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    Clinical Trial Results:
    An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

    Summary
    EudraCT number
    		 2017-003019-21
    Trial protocol
    		 BE   ES   DE   GB  
    Global end of trial date
    08 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2021
    First version publication date
    17 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IMMU-132-05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02574455
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 45
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    France: 62
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Spain: 58
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    United States: 342
    Worldwide total number of subjects
    529
    EEA total number of subjects
    167
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    428
    From 65 to 84 years
    101
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Belgium, Canada, France, Germany, Spain, the United Kingdom, and the United States. The first participant was screened on 07 November 2017. The last study visit occurred on 08 December 2020.

    Pre-assignment
    Screening details
    		 730 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sacituzumab govitecan
    Arm description
    		 Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sacituzumab govitecan
    Investigational medicinal product code
    Other name
    IMMU-132, Trodelvy®
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/kg administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump. Infusion rate for the first 15 minutes will start with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour.

    Arm title
    		 Treatment of Physician’s Choice (TPC)
    Arm description
    		 Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Eribulin
    Investigational medicinal product code
    Other name
    Halaven
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Gemzar
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Navelbine
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.

    Number of subjects in period 1
    		Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Started
    267
    262
    Completed
    0
    0
    Not completed
    267
    262
         Withdrawal of Consent
    11
    28
         Death
    197
    210
         Sponsor`s Decision
    55
    20
         Lost to follow-up
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sacituzumab govitecan
    Reporting group description
    		 Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).

    Reporting group title
    Treatment of Physician’s Choice (TPC)
    Reporting group description
    		 Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.

    Reporting group values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC) Total
    Number of subjects
    		 267 262 529
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.0 ± 11.34 54.0 ± 11.69 -
    Gender categorical
    Units: Subjects
        Female
    		 265 262 527
        Male
    		 2 0 2
    Race
    Units: Subjects
        Asian
    		 13 9 22
        Black
    		 28 34 62
        White
    		 215 203 418
        Other
    		 11 16 27
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 20 25 45
        Not Hispanic or Latino
    		 234 226 460
        Unknown or Not Reported
    		 13 11 24

    End points

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    End points reporting groups
    Reporting group title
    Sacituzumab govitecan
    Reporting group description
    		 Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).

    Reporting group title
    Treatment of Physician’s Choice (TPC)
    Reporting group description
    		 Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.

    Primary: Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population

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    End point title
    		 Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population
    End point description
    PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [≥] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. The BM-ve Population included all randomized participants who were randomized to the strata of no baseline brain metastasis at the time of randomization.
    End point type
    Primary
    End point timeframe
    From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    235
    233
    Units: months
        median (confidence interval 95%)
    5.6 (4.3 to 6.3)
    1.7 (1.5 to 2.6)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.387
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.305
         upper limit
    		 0.492
    Notes
    [1] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.

    Secondary: Progression-Free Survival (PFS) by IRC Assessment in the ITT Population

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    End point title
    		 Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
    End point description
    PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. The ITT Population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    267
    262
    Units: months
        median (confidence interval 95%)
    4.8 (4.1 to 5.8)
    1.7 (1.5 to 2.5)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.413
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 0.517
    Notes
    [2] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.

    Secondary: Overall Survival (OS) in BM-ve Population

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    End point title
    		 Overall Survival (OS) in BM-ve Population
    End point description
    Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. Participants in the BM-ve Population were analyzed.
    End point type
    Secondary
    End point timeframe
    From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    235
    233
    Units: months
        median (confidence interval 95%)
    12.1 (10.7 to 14.0)
    6.7 (5.8 to 7.7)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.481
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 0.592
    Notes
    [3] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.

    Secondary: Overall Survival (OS) in ITT Population

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    End point title
    		 Overall Survival (OS) in ITT Population
    End point description
    Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. Participants in the ITT Population were analyzed.
    End point type
    Secondary
    End point timeframe
    From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    267
    262
    Units: months
        median (confidence interval 95%)
    11.8 (10.5 to 13.8)
    6.9 (5.9 to 7.7)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.514
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.422
         upper limit
    		 0.625
    Notes
    [4] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.

    Secondary: Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population

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    End point title
    		 Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
    End point description
    ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions. Participants in the BM-ve Population with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    235
    233
    Units: percentage of participants
    number (confidence interval 95%)
        ORR by IRC Assessment N=230,230
    34.9 (28.8 to 41.4)
    4.7 (2.4 to 8.3)
        ORR by Investigator Assessment
    33.2 (27.2 to 39.6)
    6.4 (3.6 to 10.4)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    ORR by IRC Assessment
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.859
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.59
         upper limit
    		 21.095
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    ORR by Investigator Assessment
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.363
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.063
         upper limit
    		 13.341

    Secondary: Time to Objective Response by the Investigator Assessment in BM-ve Population

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    End point title
    		 Time to Objective Response by the Investigator Assessment in BM-ve Population
    End point description
    Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. Participants in the BM-ve Population with objective response were analyzed.
    End point type
    Secondary
    End point timeframe
    From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    78
    15
    Units: months
        arithmetic mean (standard deviation)
    2.14 ± 1.322
    2.72 ± 2.933
    No statistical analyses for this end point

    Secondary: Time to Objective Response by the IRC Assessment in BM-ve Population

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    End point title
    		 Time to Objective Response by the IRC Assessment in BM-ve Population
    End point description
    Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. Participants in the BM-ve Population with objective response were analyzed.
    End point type
    Secondary
    End point timeframe
    From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    82
    11
    Units: months
        arithmetic mean (standard deviation)
    2.67 ± 1.913
    1.86 ± 0.919
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population

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    End point title
    		 Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
    End point description
    DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants in the BM-ve Population with objective response were analyzed. 9999=Due to smaller number of participants with an event, upper limit of 95% confidence interval (CI) could not be calculated.
    End point type
    Secondary
    End point timeframe
    From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    82
    15
    Units: months
    median (confidence interval 95%)
        IRC Assessment N=82,11
    6.3 (5.5 to 7.9)
    3.6 (2.8 to 9999)
        Investigator Assessment N=78,15
    6.9 (5.6 to 7.9)
    3.0 (2.8 to 4.3)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    DOR by IRC Assessment
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0683 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.407
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 1.107
    Notes
    [5] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    DOR by Investigator Assessment
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [6]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.212
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.103
         upper limit
    		 0.435
    Notes
    [6] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.

    Secondary: Time to Progression (TTP) by Investigator Assessment in BM-ve Population

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    End point title
    		 Time to Progression (TTP) by Investigator Assessment in BM-ve Population
    End point description
    Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. Participants in the BM-ve Population were analyzed.
    End point type
    Secondary
    End point timeframe
    From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    235
    233
    Units: months
        median (confidence interval 95%)
    5.7 (5.2 to 6.9)
    1.8 (1.5 to 2.6)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    TTP by Investigator Assessment
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [7]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.317
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.248
         upper limit
    		 0.404
    Notes
    [7] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.

    Secondary: Time to Progression (TTP) by IRC Assessment in BM-ve Population

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    End point title
    		 Time to Progression (TTP) by IRC Assessment in BM-ve Population
    End point description
    Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. Participants in the BM-ve Population were analyzed.
    End point type
    Secondary
    End point timeframe
    From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    235
    233
    Units: months
        median (confidence interval 95%)
    5.8 (4.8 to 6.9)
    2.1 (1.5 to 2.7)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    TTP by IRC Assessment
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [8]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.406
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.315
         upper limit
    		 0.525
    Notes
    [8] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.

    Secondary: Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population

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    End point title
    		 Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
    End point description
    CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started/appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants in the BM-ve Population were analyzed.
    End point type
    Secondary
    End point timeframe
    From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    235
    233
    Units: percentage of participants
    number (confidence interval 95%)
        IRC Assessment
    44.7 (38.2 to 51.3)
    8.6 (5.3 to 12.9)
        Investigator Assessment
    45.5 (39.0 to 52.1)
    10.3 (6.7 to 14.9)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    CBR by IRC Assessment
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    8.543
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.055
         upper limit
    		 14.437
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    CBR by Investigator Assessment
    Comparison groups
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.492
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.54
         upper limit
    		 12.364

    Secondary: Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug

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    End point title
    		 Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug
    End point description
    Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute’s Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious: • Fatal • Life-threatening • Disabling/incapacitating • Results in hospitalization or prolongs a hospital stay • A congenital abnormality • Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC.
    End point type
    Secondary
    End point timeframe
    First dose date up to last follow-up (maximum up to 30.8 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    258
    224
    Units: percentage of participants
    number (not applicable)
        Any TEAEs
    99.6
    97.8
        SAEs
    26.7
    28.6
        TEAEs Leading to Discontinuation of Study Drug
    4.7
    5.4
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score

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    End point title
    		 Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score
    End point description
    The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning [phy fun], role functioning [rol fun], emotional functioning [emo fun], cognitive functioning [cog fun], social functioning [soc fun]), 1 global health status (glo hea sta) scale, 3 symptom scales (fatigue, nausea and vomiting [nau and vom], pain), and 6 single items (dyspnea, insomnia, loss of appetite [app loss], constipation [con], diarrhea, financial difficulties [fin dif]). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement. Participants in the Safety analysis set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; End of Treatment (EOT) (up to 29.6 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    258
    224
    Units: score on a scale
    arithmetic mean (standard deviation)
        Global Health Status/QoL: Baseline N=247,217
    61.9 ± 21.31
    56.4 ± 22.21
        Glo Hea Sta Change From Baseline at EOT N=181,147
    -5.8 ± 22.71
    -9.4 ± 20.46
        Physical Functioning: Baseline N=248,217
    73.2 ± 21.69
    71.2 ± 21.24
        Phy Fun Change From Baseline at EOT N=183,147
    -4.6 ± 21.07
    -13.5 ± 20.54
        Role Functioning: Baseline N=248,217
    68.1 ± 30.35
    65.1 ± 30.31
        Rol Fun Change From Baseline at EOT N=183,146
    -8.4 ± 32.87
    -18.8 ± 29.83
        Emotional Functioning: Baseline N=247,217
    71.9 ± 22.33
    68.9 ± 23.87
        Emo Fun Change From Baseline at EOT N=182,147
    -3.8 ± 25.02
    -3.5 ± 22.16
        Cognitive Functioning: Baseline N=247,217
    81.7 ± 21.08
    79.5 ± 23.91
        Cog Fun Change From Baseline at EOT N=182,147
    -7.5 ± 22.81
    -6.1 ± 22.92
        Social Functioning: Baseline N=247,216
    69.1 ± 29.96
    69.6 ± 26.88
        Soc Fun Change From Baseline at EOT N=182,145
    -5.9 ± 27.52
    -10.3 ± 29.60
        Fatigue: Baseline N=248,217
    39.4 ± 25.72
    42.1 ± 25.99
        Fatigue: Change From Baseline at EOT N=183,147
    5.1 ± 25.93
    14.0 ± 23.05
        Nausea and Vomiting: Baseline N=248,217
    8.3 ± 16.36
    10.3 ± 18.26
        Nau and Vom Change From Baseline at EOT N=183,147
    5.2 ± 23.93
    7.3 ± 23.33
        Pain: Baseline N=248,217
    37.9 ± 30.54
    42.5 ± 30.38
        Pain: Change From Baseline at EOT N=183,147
    2.8 ± 27.84
    6.8 ± 30.33
        Dyspnoea: Baseline N=248,217
    25.4 ± 30.36
    25.0 ± 29.09
        Dyspnoea: Change From Baseline at EOT N=180,146
    0.7 ± 30.91
    5.9 ± 28.95
        Insomnia: Baseline N=248,217
    33.2 ± 30.95
    35.6 ± 31.42
        Insomnia: Change From Baseline at EOT N=183,147
    4.4 ± 34.67
    -4.3 ± 32.24
        Appetite Loss: Baseline N=248,217
    20.8 ± 27.34
    25.8 ± 28.68
        App Loss: Change From Baseline at EOT N=183,147
    3.1 ± 31.78
    10.0 ± 30.32
        Constipation: Baseline N=247,217
    17.7 ± 27.18
    19.0 ± 26.56
        Con Change From Baseline at EOT N=182,147
    3.3 ± 28.92
    7.0 ± 31.27
        Diarrhoea: Baseline N=247,217
    7.2 ± 17.73
    6.5 ± 15.69
        Diarrhoea: Change From Baseline at EOT N=182,147
    11.4 ± 28.56
    3.6 ± 22.46
        Financial Difficulties: Baseline N=246,217
    27.6 ± 34.39
    22.4 ± 30.91
        Fin Dif Change From Baseline at EOT N=181,147
    0.4 ± 24.09
    1.1 ± 23.54
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline

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    End point title
    		 Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
    End point description
    Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported. Participants in the Safety analysis set were analyzed.
    End point type
    Secondary
    End point timeframe
    First dose date up to last follow-up (maximum up to 30.8 months)
    End point values
    		 Sacituzumab govitecan Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    258
    224
    Units: percentage of participants
    number (not applicable)
        Anemia
    8.9
    5.4
        Lymphocyte Count Decreased
    33.3
    25.0
        Neutrophil Count Decreased
    48.8
    35.3
        Platelet Count Decreased
    1.2
    2.7
        White Blood Cell Decreased
    41.1
    25.4
        Alanine Aminotransferase Increased
    1.2
    2.2
        Alkaline Phosphatase Increased
    3.1
    3.6
        Aspartate Aminotransferase Increased
    3.5
    2.2
        Blood Bilirubin Increased
    1.9
    2.7
        Creatinine Increased
    0.4
    0
        Hypercalcemia
    0
    0.4
        Hyperglycemia
    3.1
    3.1
        Hyperkalemia
    0.8
    0
        Hypermagnesemia
    0.4
    0.4
        Hypernatremia
    0
    0
        Hypoalbumenemia
    0.8
    1.3
        Hypocalcemia
    1.6
    1.3
        Hypoglycemia
    0.4
    0
        Hypokalemia
    4.3
    0.9
        Hypomagnesemia
    0.8
    0
        Hyponatremia
    3.9
    3.6
        Hypophosphatemia
    8.1
    3.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events: First dose date up to last follow-up (maximum up to 30.8 months); All-Cause Mortality: From randomization up to 30.8 months
    Adverse event reporting additional description
    Serious Adverse Events and Other Adverse Events: Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC. All-Cause Mortality: The ITT Population included all randomized participants (i.e. participants exposed, sacituzumab govitecan=267, TPC=262).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Treatment of Physician’s Choice (TPC)
    Reporting group description
    		 Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.

    Reporting group title
    Sacituzumab Govitecan
    Reporting group description
    		 Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.

    Serious adverse events
    		 Treatment of Physician’s Choice (TPC) Sacituzumab Govitecan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    64 / 224 (28.57%)
    69 / 258 (26.74%)
         number of deaths (all causes)
    222
    201
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour haemorrhage
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 224 (0.45%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pregnancy
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 224 (2.23%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    2 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyperthermia
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion site extravasation
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast ulceration
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    7 / 224 (3.13%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    6 / 224 (2.68%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 224 (0.89%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 224 (0.89%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypoxia
         subjects affected / exposed
    1 / 224 (0.45%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 224 (0.45%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood lactic acid increased
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation necrosis
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    2 / 224 (0.89%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 224 (0.00%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    4 / 224 (1.79%)
    13 / 258 (5.04%)
         occurrences causally related to treatment / all
    4 / 4
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 224 (0.45%)
    5 / 258 (1.94%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    2 / 224 (0.89%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 224 (0.00%)
    9 / 258 (3.49%)
         occurrences causally related to treatment / all
    0 / 0
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 224 (1.34%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 224 (0.00%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 224 (0.00%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 224 (1.79%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 224 (1.79%)
    7 / 258 (2.71%)
         occurrences causally related to treatment / all
    3 / 4
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 224 (1.79%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 224 (0.89%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 224 (0.00%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 224 (0.45%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corynebacterium infection
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Phlebitis infective
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment of Physician’s Choice (TPC) Sacituzumab Govitecan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    213 / 224 (95.09%)
    256 / 258 (99.22%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    14 / 224 (6.25%)
    17 / 258 (6.59%)
         occurrences all number
    21
    34
    Lymphoedema
         subjects affected / exposed
    7 / 224 (3.13%)
    14 / 258 (5.43%)
         occurrences all number
    7
    14
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    28 / 224 (12.50%)
    39 / 258 (15.12%)
         occurrences all number
    34
    57
    Fatigue
         subjects affected / exposed
    89 / 224 (39.73%)
    133 / 258 (51.55%)
         occurrences all number
    110
    181
    Pyrexia
         subjects affected / exposed
    27 / 224 (12.05%)
    37 / 258 (14.34%)
         occurrences all number
    40
    49
    Oedema peripheral
         subjects affected / exposed
    24 / 224 (10.71%)
    25 / 258 (9.69%)
         occurrences all number
    25
    28
    Pain
         subjects affected / exposed
    11 / 224 (4.91%)
    18 / 258 (6.98%)
         occurrences all number
    12
    18
    Mucosal inflammation
         subjects affected / exposed
    14 / 224 (6.25%)
    20 / 258 (7.75%)
         occurrences all number
    16
    23
    Chills
         subjects affected / exposed
    6 / 224 (2.68%)
    14 / 258 (5.43%)
         occurrences all number
    6
    16
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    8 / 224 (3.57%)
    14 / 258 (5.43%)
         occurrences all number
    9
    15
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    41 / 224 (18.30%)
    45 / 258 (17.44%)
         occurrences all number
    46
    50
    Cough
         subjects affected / exposed
    40 / 224 (17.86%)
    61 / 258 (23.64%)
         occurrences all number
    41
    75
    Oropharyngeal pain
         subjects affected / exposed
    9 / 224 (4.02%)
    14 / 258 (5.43%)
         occurrences all number
    10
    17
    Dyspnoea exertional
         subjects affected / exposed
    3 / 224 (1.34%)
    13 / 258 (5.04%)
         occurrences all number
    3
    14
    Nasal congestion
         subjects affected / exposed
    3 / 224 (1.34%)
    13 / 258 (5.04%)
         occurrences all number
    3
    14
    Rhinorrhoea
         subjects affected / exposed
    1 / 224 (0.45%)
    15 / 258 (5.81%)
         occurrences all number
    1
    15
    Epistaxis
         subjects affected / exposed
    1 / 224 (0.45%)
    13 / 258 (5.04%)
         occurrences all number
    1
    15
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    11 / 224 (4.91%)
    30 / 258 (11.63%)
         occurrences all number
    11
    33
    Anxiety
         subjects affected / exposed
    8 / 224 (3.57%)
    17 / 258 (6.59%)
         occurrences all number
    8
    18
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    45 / 224 (20.09%)
    71 / 258 (27.52%)
         occurrences all number
    97
    185
    Aspartate aminotransferase increased
         subjects affected / exposed
    27 / 224 (12.05%)
    30 / 258 (11.63%)
         occurrences all number
    31
    50
    White blood cell count decreased
         subjects affected / exposed
    23 / 224 (10.27%)
    33 / 258 (12.79%)
         occurrences all number
    37
    80
    Alanine aminotransferase increased
         subjects affected / exposed
    22 / 224 (9.82%)
    28 / 258 (10.85%)
         occurrences all number
    25
    43
    Weight decreased
         subjects affected / exposed
    15 / 224 (6.70%)
    22 / 258 (8.53%)
         occurrences all number
    15
    24
    Lymphocyte count decreased
         subjects affected / exposed
    13 / 224 (5.80%)
    20 / 258 (7.75%)
         occurrences all number
    17
    44
    Platelet count decreased
         subjects affected / exposed
    15 / 224 (6.70%)
    7 / 258 (2.71%)
         occurrences all number
    17
    20
    Blood alkaline phosphatase increased
         subjects affected / exposed
    12 / 224 (5.36%)
    17 / 258 (6.59%)
         occurrences all number
    13
    28
    Nervous system disorders
    Headache
         subjects affected / exposed
    28 / 224 (12.50%)
    47 / 258 (18.22%)
         occurrences all number
    30
    64
    Dizziness
         subjects affected / exposed
    16 / 224 (7.14%)
    28 / 258 (10.85%)
         occurrences all number
    19
    34
    Neuropathy peripheral
         subjects affected / exposed
    24 / 224 (10.71%)
    9 / 258 (3.49%)
         occurrences all number
    25
    10
    Dysgeusia
         subjects affected / exposed
    6 / 224 (2.68%)
    22 / 258 (8.53%)
         occurrences all number
    11
    23
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    56 / 224 (25.00%)
    108 / 258 (41.86%)
         occurrences all number
    108
    275
    Anaemia
         subjects affected / exposed
    61 / 224 (27.23%)
    102 / 258 (39.53%)
         occurrences all number
    72
    145
    Thrombocytopenia
         subjects affected / exposed
    14 / 224 (6.25%)
    9 / 258 (3.49%)
         occurrences all number
    18
    14
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    68 / 224 (30.36%)
    160 / 258 (62.02%)
         occurrences all number
    95
    288
    Diarrhoea
         subjects affected / exposed
    38 / 224 (16.96%)
    168 / 258 (65.12%)
         occurrences all number
    63
    403
    Constipation
         subjects affected / exposed
    52 / 224 (23.21%)
    96 / 258 (37.21%)
         occurrences all number
    68
    160
    Vomiting
         subjects affected / exposed
    36 / 224 (16.07%)
    85 / 258 (32.95%)
         occurrences all number
    51
    165
    Stomatitis
         subjects affected / exposed
    14 / 224 (6.25%)
    27 / 258 (10.47%)
         occurrences all number
    17
    36
    Abdominal pain
         subjects affected / exposed
    16 / 224 (7.14%)
    54 / 258 (20.93%)
         occurrences all number
    20
    74
    Abdominal pain upper
         subjects affected / exposed
    8 / 224 (3.57%)
    23 / 258 (8.91%)
         occurrences all number
    9
    24
    Gastrooesophageal reflux disease
         subjects affected / exposed
    7 / 224 (3.13%)
    14 / 258 (5.43%)
         occurrences all number
    7
    14
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    36 / 224 (16.07%)
    121 / 258 (46.90%)
         occurrences all number
    36
    124
    Rash
         subjects affected / exposed
    12 / 224 (5.36%)
    32 / 258 (12.40%)
         occurrences all number
    15
    44
    Pruritus
         subjects affected / exposed
    7 / 224 (3.13%)
    26 / 258 (10.08%)
         occurrences all number
    7
    34
    Rash maculo-papular
         subjects affected / exposed
    3 / 224 (1.34%)
    18 / 258 (6.98%)
         occurrences all number
    3
    25
    Dry skin
         subjects affected / exposed
    3 / 224 (1.34%)
    17 / 258 (6.59%)
         occurrences all number
    3
    18
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    30 / 224 (13.39%)
    44 / 258 (17.05%)
         occurrences all number
    31
    51
    Arthralgia
         subjects affected / exposed
    16 / 224 (7.14%)
    33 / 258 (12.79%)
         occurrences all number
    18
    39
    Pain in extremity
         subjects affected / exposed
    17 / 224 (7.59%)
    21 / 258 (8.14%)
         occurrences all number
    19
    28
    Bone pain
         subjects affected / exposed
    14 / 224 (6.25%)
    21 / 258 (8.14%)
         occurrences all number
    18
    26
    Myalgia
         subjects affected / exposed
    19 / 224 (8.48%)
    12 / 258 (4.65%)
         occurrences all number
    22
    13
    Musculoskeletal chest pain
         subjects affected / exposed
    6 / 224 (2.68%)
    17 / 258 (6.59%)
         occurrences all number
    6
    21
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    17 / 224 (7.59%)
    35 / 258 (13.57%)
         occurrences all number
    19
    47
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 224 (3.13%)
    32 / 258 (12.40%)
         occurrences all number
    8
    44
    Nasopharyngitis
         subjects affected / exposed
    5 / 224 (2.23%)
    18 / 258 (6.98%)
         occurrences all number
    5
    23
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    46 / 224 (20.54%)
    71 / 258 (27.52%)
         occurrences all number
    56
    75
    Hypokalaemia
         subjects affected / exposed
    29 / 224 (12.95%)
    46 / 258 (17.83%)
         occurrences all number
    30
    72
    Hyperglycaemia
         subjects affected / exposed
    12 / 224 (5.36%)
    18 / 258 (6.98%)
         occurrences all number
    17
    38
    Hypomagnesaemia
         subjects affected / exposed
    13 / 224 (5.80%)
    32 / 258 (12.40%)
         occurrences all number
    16
    42
    Hypophosphataemia
         subjects affected / exposed
    9 / 224 (4.02%)
    15 / 258 (5.81%)
         occurrences all number
    18
    20
    Hypocalcaemia
         subjects affected / exposed
    5 / 224 (2.23%)
    17 / 258 (6.59%)
         occurrences all number
    6
    23

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2017
    • Added guidelines for infusion reactions, dose delay, dose reduction and treatment discontinuation • Added the inclusion criterion that all participants should have been previously treated with taxane regardless of disease stage (adjuvant, neoadjuvant or advanced) when it was given • Revised the inclusion criterion that participants with treated, non-progressive brain metastases must have stable magnetic resonance imaging (MRI) scans for at least 3 months, including within 4 weeks of study entry • Added collection of breast cancer susceptibility gene (BRCA) 1 and BRCA2 mutational status, if known • Removed baseline brain imaging requirement to rule out brain metastases • Removed the CTCAE patient-reported outcome (PRO) questionnaire.
    31 Jul 2017
    • Revised the computed tomography (CT)/MRI scans from every 6 weeks for 24 weeks to every 6 weeks for 36 weeks.
    22 Feb 2018
    • Allowed participants with locally advanced TNBC to be enrolled • Sample size increased from 328 to 488 participants • Defined as <10% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization • Added the secondary objective and secondary efficacy endpoint of PFS in the ITT Population • Added that ORR and PFS would also be determined by the investigator • Added PFS and OS in the ITT Population • Added an exploratory analysis of Trop-2 tumor expression and efficacy • Increased the sample size and number of participating sites • Limited the number of participants with brain metastasis at 15% • Added eligibility requirements for participants who had either a contraindication or were intolerant to taxanes • Excluded participants who had received >5 prior standard of care chemotherapies for locally advanced or metastatic disease • Excluded participants with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and participants with a history of bowel obstruction • Excluded participants who had received a live vaccine within 30 days of randomization.
    14 May 2018
    • Removed secondary objective and secondary efficacy endpoint of PFS by investigator assessment • Added inclusion criteria that defined stable CNS disease for participants with brain metastasis • Removed the exclusion of participants who had received >5 prior standard of care chemotherapies for locally advanced or metastatic disease • Excluded participants who had previously received irinotecan • Excluded participants with rapid deterioration during screening • Added a hierarchical testing strategy for efficacy.
    14 Jun 2019
    • Removed assessment of other tumor markers • Clarified that both total and free SN-38 (a camptothecin-derived agent) would be assessed • Added that participants who were receiving clinical benefit from sacituzumab govitecan (SG) at the end of the study would be enrolled in a rollover study to ensure continued access to SG • Added that disease progression was not to be reported as an AE • Removed the interim futility analysis for PFS • Added that the significance level for the final analysis of OS in the ITT population would be determined by the Lan-DeMets spending function to ensure alpha was controlled at a 2-sided alpha of 0.05 which was subsequently changed to a 2-sided alpha of 0.0443.
    26 Aug 2019
    • Clarified PK sampling time points.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30786188
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