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    Clinical Trial Results:
    Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

    Summary
    EudraCT number
    		 2018-004201-33
    Trial protocol
    		 GB   FR   DE   NL   ES   BE   IT  
    Global end of trial date
    20 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2024
    First version publication date
    11 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IMMU-132-09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03901339
    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
    20 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).
    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
    08 May 2019
    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: 25
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    France: 137
    Country: Number of subjects enrolled
    Germany: 46
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Spain: 69
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    United States: 228
    Worldwide total number of subjects
    543
    EEA total number of subjects
    300
    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)
    403
    From 65 to 84 years
    139
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Belgium, Canada, France, Germany, Italy, the Netherlands, Spain, the United Kingdom, and the United States.

    Pre-assignment
    Screening details
    		 776 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 on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met (up to 40.1 months).
    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 of body weight, administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump.

    Arm title
    		 Treatment of Physician's Choice (TPC)
    Arm description
    		 Participants received TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as single-agent treatment determined by investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per National Comprehensive Cancer Network guidelines (with dose modifications for if toxic) • Eribulin was administered IV at dose 1.4 mg/m^2 at North American sites; 1.2 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). • Capecitabine 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 (up to 12.9 months). • Gemcitabine 800 to 1200 mg/m^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). • Vinorelbine 25 mg/m^2 was administered as weekly IV injection (up to 8.1 months) and was not allowed as TPC for any participant with Grade 2 neuropathy
    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
    Eribulin was administered IV at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites.

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Navelbine
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vinorelbine 25 mg/m^2 was administered as a weekly IV injection.

    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
    Gemcitabine 800 to 1200 mg/m^2 was administered IV.

    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
    Capecitabine 1000 to 1250 mg/m^2 was administered orally twice daily for 2 weeks followed by 1-week rest period.

    Number of subjects in period 1
    		Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Started
    272
    271
    Completed
    0
    0
    Not completed
    272
    271
         Death
    220
    192
         Sponsor request
    30
    23
         Reason not specified
    5
    7
         Lost to follow-up
    4
    7
         Informed consent withdrawn
    13
    40
         Covid19
    -
    2

    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 on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met (up to 40.1 months).

    Reporting group title
    Treatment of Physician's Choice (TPC)
    Reporting group description
    		 Participants received TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as single-agent treatment determined by investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per National Comprehensive Cancer Network guidelines (with dose modifications for if toxic) • Eribulin was administered IV at dose 1.4 mg/m^2 at North American sites; 1.2 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). • Capecitabine 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 (up to 12.9 months). • Gemcitabine 800 to 1200 mg/m^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). • Vinorelbine 25 mg/m^2 was administered as weekly IV injection (up to 8.1 months) and was not allowed as TPC for any participant with Grade 2 neuropathy

    Reporting group values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC) Total
    Number of subjects
    		 272 271 543
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 199 204 403
        From 65-84 years
    		 72 67 139
        85 years and over
    		 1 0 1
    Gender categorical
    Units: Subjects
        Female
    		 270 268 538
        Male
    		 2 3 5
    Race
    Units: Subjects
        White
    		 184 178 362
        Unknown or Not Reported
    		 69 70 139
        Black or African American
    		 8 13 21
        Asian
    		 11 5 16
        Other or More Than One Race
    		 0 4 4
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
    Ethnicity
    PLACEHOLDER0
    Units: Subjects
        Hispanic or Latino
    		 6 12 18
        Not Hispanic or Latino
    		 222 204 426
        Unknown or Not Reported
    		 44 55 99

    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 on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met (up to 40.1 months).

    Reporting group title
    Treatment of Physician's Choice (TPC)
    Reporting group description
    		 Participants received TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as single-agent treatment determined by investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per National Comprehensive Cancer Network guidelines (with dose modifications for if toxic) • Eribulin was administered IV at dose 1.4 mg/m^2 at North American sites; 1.2 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). • Capecitabine 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 (up to 12.9 months). • Gemcitabine 800 to 1200 mg/m^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). • Vinorelbine 25 mg/m^2 was administered as weekly IV injection (up to 8.1 months) and was not allowed as TPC for any participant with Grade 2 neuropathy

    Primary: Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment

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    End point title
    		 Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment
    End point description
    PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not.
    End point type
    Primary
    End point timeframe
    Up to 42.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    272
    271
    Units: months
        median (confidence interval 95%)
    5.5 (4.2 to 6.9)
    4.0 (3.0 to 4.4)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    Sacituzumab Govitecan vs Treatment of Physician's Choice (TPC)
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.653
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.526
         upper limit
    		 0.812
    Notes
    [1] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis and endocrine therapy in the metastatic setting for at least 6 months.

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time from the date of randomization to the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive. Participants in the ITT Population were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 42.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    272
    271
    Units: months
        median (confidence interval 95%)
    14.5 (13.0 to 16.0)
    11.2 (10.2 to 12.6)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0133 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.788
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.652
         upper limit
    		 0.952
    Notes
    [2] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.

    Secondary: Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment

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    End point title
    		 Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment
    End point description
    ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR) that was confirmed at 4 weeks or later after initial response by BICR and LIR using RECIST 1.1. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Participants in the ITT Population with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 42.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    272
    271
    Units: percentage of participants
    number (confidence interval 95%)
        ORR by BICR Assessment
    21.3 (16.6 to 26.7)
    14.0 (10.1 to 18.7)
        ORR by LIR Assessment
    16.5 (12.3 to 21.5)
    9.2 (6.1 to 13.3)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    ORR by BICR Assessment
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0268
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.662
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.058
         upper limit
    		 2.609
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    ORR by LIR Assessment
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0098
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.989
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.174
         upper limit
    		 3.369

    Secondary: Clinical Benefit Rate (CBR) by BICR and LIR Assessment

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    End point title
    		 Clinical Benefit Rate (CBR) by BICR and LIR Assessment
    End point description
    CBR was defined as the percentage of participants with the best overall response of CR, PR, or durable stable disease (duration of SD ≥ 6 months after randomization). CBR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. 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. PD: Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. Participants in the ITT Population with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 42.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    272
    271
    Units: percentage of participants
    number (confidence interval 95%)
        CBR by BICR Assessment
    33.8 (28.2 to 39.8)
    22.1 (17.3 to 27.6)
        CBR by LIR Assessment
    32.4 (26.8 to 38.3)
    21.0 (16.3 to 26.4)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    CBR by BICR Assessment
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0025
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.796
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.227
         upper limit
    		 2.628
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    CBR by LIR Assessment
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0024
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.834
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.237
         upper limit
    		 2.717

    Secondary: Duration of Response (DOR) by BICR and LIR Assessment

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    End point title
    		 Duration of Response (DOR) by BICR and LIR Assessment
    End point description
    DOR was defined as the time from the date a response of CR or PR was first documented until the date of the first documentation of disease progression or date of death (whichever occurred first). DOR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. DOR was estimated using Kaplan-Meier estimate. Participants in the ITT Population with confirmed objective response were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 42.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    58
    38
    Units: months
    median (confidence interval 95%)
        DOR by BICR Assessment
    8.1 (6.7 to 8.9)
    5.6 (3.8 to 7.9)
        DOR by LIR Assessment N=45,25
    7.0 (5.6 to 8.9)
    4.3 (4.2 to 6.1)
    No statistical analyses for this end point

    Secondary: PFS by LIR Assessment

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    End point title
    		 PFS by LIR Assessment
    End point description
    PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to LIR using RECIST 1.1. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. Participants in the ITT Population were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 42.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    272
    271
    Units: months
        median (confidence interval 95%)
    4.3 (3.8 to 5.4)
    3.1 (2.7 to 4.0)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    PFS by LIR Assessment
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.728
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.602
         upper limit
    		 0.881
    Notes
    [3] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.

    Secondary: Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30)

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    End point title
    		 Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30)
    End point description
    TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the global health status/QoL scale.The EORTC QLQ-C30 is a 30-item questionnaire to assess QoL of cancer patients.Responses to global health status,'How would you rate your overall health during the past week?' (Item 29)and the QoL 'How would you rate your overall quality of life during the past week?'(Item 30)questions were scored on 7-point scale (1=very poor; 7=excellent). All scales and single-item measures range in score from 0 to 100. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores for GHS show a better level of functioning. The HRQOL-Evaluable Population included all participants who had an evaluable assessment at baseline and at least 1 evaluable assessment at postbaseline visits. Participants with a baseline global health status/QOL score ≥ 10 were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 37.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    234
    207
    Units: months
        median (confidence interval 95%)
    4.3 (3.1 to 5.7)
    3.0 (2.2 to 3.9)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    Sacituzumab Govitecan vs Treatment of Physician's Choice (TPC))
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    441
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0059 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.751
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.612
         upper limit
    		 0.922
    Notes
    [4] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.

    Secondary: Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (TESAEs)
    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 5.0. 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 Participants in the Safety Population were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 43.4 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    268
    249
    Units: percentage of participants
        number (not applicable)
    27.6
    19.3
    No statistical analyses for this end point

    Secondary: TTD of Fatigue Score as Measured by EORTC QLQ-C30

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    End point title
    		 TTD of Fatigue Score as Measured by EORTC QLQ-C30
    End point description
    TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the fatigue score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in functional scales,1 global health status scale,symptom scales,and single items.All of the scales and single-item measures range in score from 0 to 100.Participant responses to 3 questions about fatigue 'Did you need to rest', 'Have you felt weak' and 'Were you tired' were scored on a 4-point scale (1=not at all;4=very much).Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant). Participants in the HRQOL-Evaluable Population with baseline fatigue score ≤ 90 were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 37.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    234
    205
    Units: months
        median (confidence interval 95%)
    2.2 (1.6 to 2.8)
    1.4 (1.1 to 1.9)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    439
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0021 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.732
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.598
         upper limit
    		 0.894
    Notes
    [5] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.

    Secondary: Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
    End point description
    An AE was defined as any untoward medical occurrence in a subject administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. The Safety Population included all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 43.4 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    268
    249
    Units: percentage of participants
        number (not applicable)
    100.0
    96.0
    No statistical analyses for this end point

    Secondary: TTD of Pain Score as Measured by EORTC QLQ-C30

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    End point title
    		 TTD of Pain Score as Measured by EORTC QLQ-C30
    End point description
    TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the pain score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in functional scales,global health status scale,3 symptom scales,and 6 single items.All of the scales and single-item measures range in score from 0 to 100. Participant responses to 2 questions about pain, 'Have you had pain' and 'Did pain interfere with your daily activities' were scored on 4-point scale (1=not at all;4=very much). Summed raw scores were standardized by linear transformation so that scores ranges from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant). Participants in the HRQOL-Evaluable Population with baseline pain score ≤ 90 were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 37.8 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    229
    202
    Units: months
        median (confidence interval 95%)
    3.8 (2.8 to 5.0)
    3.5 (2.8 to 5.0)
    Statistical analysis title
    		 Sacituzumab Govitecan vs TPC
    Statistical analysis description
    Sacituzumab govitecan v Treatment of Physician’s Choice (TPC)
    Comparison groups
    Sacituzumab Govitecan v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    431
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4151 [6]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.918
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.748
         upper limit
    		 1.126
    Notes
    [6] - Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.

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

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    End point title
    		 Percentage of Participants Who Experienced 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. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.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 Population with post-baseline values were analyzed.'Number Analyzed' indicates participants with post-baseline values with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 43.4 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    265
    242
    Units: percentage of participants
    number (not applicable)
        Alanine Aminotransferase Increased N=264,237
    1.1
    2.1
        Hypoalbuminemia N=262,236
    0
    0.4
        Alkaline Phosphatase Increased N=263,237
    0
    0.8
        Aspartate Aminotransferase Increased N=264,237
    1.5
    1.3
        Bilirubin Increased N=264,237
    2.3
    0.8
        Creatinine Increased N=263,237
    0.4
    1.7
        Creatinine Clearance Decreased N=263,237
    2.3
    1.3
        Hypoglycemia N=262,237
    1.1
    0.8
        Hypermagnesemia N=260,233
    0.4
    0
        Hypomagnesemia N=260,233
    0.8
    0
        Hyperkalemia N=263,237
    1.9
    0
        Hypokalemia N=263,237
    4.2
    0.4
        Hyponatremia N=263,237
    0.8
    0.4
        Anemia N=265,241
    7.5
    5.0
        Hemoglobin Increased N=265,241
    1.1
    0
        Leukocytes Decreased N=265,241
    38.9
    25.7
        Leukocytosis N=265,241
    0.4
    0.4
        Lymphocytes Decreased N=265,241
    21.5
    13.7
        Lymphocytes Increased N=265,241
    1.9
    2.1
        Neutrophils Decreased N=265,241
    53.2
    40.2
        Platelets Decreased N=265,241
    1.9
    3.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Shift from Baseline Value to Best Value During Treatment

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    End point title
    		 Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Shift from Baseline Value to Best Value During Treatment
    End point description
    ECOG performance status (PS) measured on-therapy assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease performance without restriction;1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature;2=Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;3=Capable of only limited self-care;confined to bed or chair more than 50% of waking hours;4=Completely disabled; cannot carry on any self-care; totally confined to bed or chair;5=Dead. Lower score indicated good performance status. Percentage of participants with Baseline ECOG PS score and corresponding changes to the best values post-baseline have been reported. Participants in the Safety Population were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 43.4 months
    End point values
    		 Sacituzumab Govitecan Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    268
    249
    Units: percentage of participants
    number (not applicable)
        Baseline ECOG 0, During Treatment ECOG 0
    34.9
    38.7
        Baseline ECOG 0, During Treatment ECOG 1
    7.8
    8.9
        Baseline ECOG 0, During Treatment ECOG 2
    0
    0.4
        Baseline ECOG 1, During Treatment ECOG 0
    19.4
    11.5
        Baseline ECOG 1, During Treatment ECOG 1
    36.4
    38.3
        Baseline ECOG 1, During Treatment ECOG 2
    1.6
    2.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events and All-Cause Mortality: Up to 43.4 months
    Adverse event reporting additional description
    Adverse Events: The Safety Population included all participants who received at least 1 dose of study drug; All-Cause Mortality: The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Treatment of Physician's Choice (TPC)
    Reporting group description
    		 Participants received TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as single-agent treatment determined by investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per National Comprehensive Cancer Network guidelines (with dose modifications for if toxic) • Eribulin was administered IV at dose 1.4 mg/m^2 at North American sites; 1.2 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). • Capecitabine 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 (up to 12.9 months). • Gemcitabine 800 to 1200 mg/m^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). • Vinorelbine 25 mg/m^2 was administered as weekly IV injection (up to 8.1 months) and was not allowed as TPC for any participant with Grade 2 neuropathy.

    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 on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met (up to 40.1 months).

    Serious adverse events
    		 Treatment of Physician's Choice (TPC) Sacituzumab Govitecan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    48 / 249 (19.28%)
    74 / 268 (27.61%)
         number of deaths (all causes)
    238
    234
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 268 (1.12%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health ~ deterioration
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 249 (1.61%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumothorax
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 249 (0.80%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device leakage
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Liver function test increased
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose decreased
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Compression fracture
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (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
    Nervous system disorder
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epilepsy
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    10 / 249 (4.02%)
    11 / 268 (4.10%)
         occurrences causally related to treatment / all
    10 / 10
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 249 (0.80%)
    8 / 268 (2.99%)
         occurrences causally related to treatment / all
    2 / 2
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 249 (0.00%)
    6 / 268 (2.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 249 (0.80%)
    5 / 268 (1.87%)
         occurrences causally related to treatment / all
    2 / 2
    6 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    5 / 249 (2.01%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 249 (0.40%)
    13 / 268 (4.85%)
         occurrences causally related to treatment / all
    1 / 1
    12 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 249 (0.40%)
    4 / 268 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    0 / 249 (0.00%)
    5 / 268 (1.87%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract obstruction
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 249 (0.40%)
    3 / 268 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Secondary adrenocortical ~ insufficiency
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 249 (1.20%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection ~ viral
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 249 (2.01%)
    4 / 268 (1.49%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 268 (1.12%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 249 (0.40%)
    3 / 268 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Covid-19 pneumonia
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Anal abscess
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii infection
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 249 (0.80%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         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
    234 / 249 (93.98%)
    264 / 268 (98.51%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    44 / 249 (17.67%)
    34 / 268 (12.69%)
         occurrences all number
    66
    54
    Alanine aminotransferase increased
         subjects affected / exposed
    37 / 249 (14.86%)
    30 / 268 (11.19%)
         occurrences all number
    52
    46
    Blood alkaline phosphatase increased
         subjects affected / exposed
    27 / 249 (10.84%)
    25 / 268 (9.33%)
         occurrences all number
    30
    36
    Weight decreased
         subjects affected / exposed
    14 / 249 (5.62%)
    15 / 268 (5.60%)
         occurrences all number
    14
    15
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    13 / 249 (5.22%)
    9 / 268 (3.36%)
         occurrences all number
    15
    9
    Blood bilirubin increased
         subjects affected / exposed
    14 / 249 (5.62%)
    8 / 268 (2.99%)
         occurrences all number
    16
    9
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 249 (4.42%)
    16 / 268 (5.97%)
         occurrences all number
    12
    19
    Nervous system disorders
    Headache
         subjects affected / exposed
    36 / 249 (14.46%)
    44 / 268 (16.42%)
         occurrences all number
    44
    54
    Dizziness
         subjects affected / exposed
    10 / 249 (4.02%)
    23 / 268 (8.58%)
         occurrences all number
    11
    30
    Neuropathy peripheral
         subjects affected / exposed
    20 / 249 (8.03%)
    11 / 268 (4.10%)
         occurrences all number
    24
    12
    Peripheral sensory neuropathy
         subjects affected / exposed
    16 / 249 (6.43%)
    10 / 268 (3.73%)
         occurrences all number
    18
    10
    Paraesthesia
         subjects affected / exposed
    14 / 249 (5.62%)
    8 / 268 (2.99%)
         occurrences all number
    14
    8
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    41 / 249 (16.47%)
    17 / 268 (6.34%)
         occurrences all number
    61
    23
    Lymphopenia
         subjects affected / exposed
    29 / 249 (11.65%)
    32 / 268 (11.94%)
         occurrences all number
    39
    70
    Leukopenia
         subjects affected / exposed
    25 / 249 (10.04%)
    37 / 268 (13.81%)
         occurrences all number
    38
    67
    Anaemia
         subjects affected / exposed
    68 / 249 (27.31%)
    97 / 268 (36.19%)
         occurrences all number
    82
    128
    Neutropenia
         subjects affected / exposed
    134 / 249 (53.82%)
    184 / 268 (68.66%)
         occurrences all number
    257
    409
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    14 / 249 (5.62%)
    17 / 268 (6.34%)
         occurrences all number
    14
    19
    Pain
         subjects affected / exposed
    11 / 249 (4.42%)
    14 / 268 (5.22%)
         occurrences all number
    11
    14
    Mucosal inflammation
         subjects affected / exposed
    14 / 249 (5.62%)
    23 / 268 (8.58%)
         occurrences all number
    16
    36
    Pyrexia
         subjects affected / exposed
    44 / 249 (17.67%)
    38 / 268 (14.18%)
         occurrences all number
    65
    46
    Asthenia
         subjects affected / exposed
    49 / 249 (19.68%)
    62 / 268 (23.13%)
         occurrences all number
    56
    97
    Fatigue
         subjects affected / exposed
    81 / 249 (32.53%)
    106 / 268 (39.55%)
         occurrences all number
    90
    114
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    86 / 249 (34.54%)
    157 / 268 (58.58%)
         occurrences all number
    107
    233
    Diarrhoea
         subjects affected / exposed
    57 / 249 (22.89%)
    163 / 268 (60.82%)
         occurrences all number
    76
    311
    Abdominal pain
         subjects affected / exposed
    34 / 249 (13.65%)
    51 / 268 (19.03%)
         occurrences all number
    37
    70
    Vomiting
         subjects affected / exposed
    39 / 249 (15.66%)
    63 / 268 (23.51%)
         occurrences all number
    70
    95
    Constipation
         subjects affected / exposed
    61 / 249 (24.50%)
    93 / 268 (34.70%)
         occurrences all number
    71
    125
    Dry mouth
         subjects affected / exposed
    5 / 249 (2.01%)
    16 / 268 (5.97%)
         occurrences all number
    5
    16
    Gastrooesophageal reflux disease
         subjects affected / exposed
    9 / 249 (3.61%)
    14 / 268 (5.22%)
         occurrences all number
    9
    15
    Abdominal distension
         subjects affected / exposed
    8 / 249 (3.21%)
    17 / 268 (6.34%)
         occurrences all number
    9
    18
    Dyspepsia
         subjects affected / exposed
    7 / 249 (2.81%)
    19 / 268 (7.09%)
         occurrences all number
    7
    21
    Stomatitis
         subjects affected / exposed
    18 / 249 (7.23%)
    23 / 268 (8.58%)
         occurrences all number
    20
    34
    Abdominal pain upper
         subjects affected / exposed
    15 / 249 (6.02%)
    26 / 268 (9.70%)
         occurrences all number
    16
    27
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    38 / 249 (15.26%)
    48 / 268 (17.91%)
         occurrences all number
    43
    59
    Cough
         subjects affected / exposed
    18 / 249 (7.23%)
    33 / 268 (12.31%)
         occurrences all number
    21
    40
    Epistaxis
         subjects affected / exposed
    6 / 249 (2.41%)
    22 / 268 (8.21%)
         occurrences all number
    6
    23
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    14 / 249 (5.62%)
    24 / 268 (8.96%)
         occurrences all number
    14
    27
    Alopecia
         subjects affected / exposed
    46 / 249 (18.47%)
    128 / 268 (47.76%)
         occurrences all number
    47
    129
    Pruritus
         subjects affected / exposed
    6 / 249 (2.41%)
    32 / 268 (11.94%)
         occurrences all number
    6
    37
    Dry skin
         subjects affected / exposed
    8 / 249 (3.21%)
    18 / 268 (6.72%)
         occurrences all number
    8
    18
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    14 / 249 (5.62%)
    6 / 268 (2.24%)
         occurrences all number
    16
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    19 / 249 (7.63%)
    21 / 268 (7.84%)
         occurrences all number
    21
    24
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    29 / 249 (11.65%)
    40 / 268 (14.93%)
         occurrences all number
    30
    46
    Back pain
         subjects affected / exposed
    30 / 249 (12.05%)
    35 / 268 (13.06%)
         occurrences all number
    32
    40
    Bone pain
         subjects affected / exposed
    16 / 249 (6.43%)
    21 / 268 (7.84%)
         occurrences all number
    18
    24
    Myalgia
         subjects affected / exposed
    20 / 249 (8.03%)
    17 / 268 (6.34%)
         occurrences all number
    22
    26
    Muscle spasms
         subjects affected / exposed
    11 / 249 (4.42%)
    19 / 268 (7.09%)
         occurrences all number
    12
    23
    Pain in extremity
         subjects affected / exposed
    13 / 249 (5.22%)
    17 / 268 (6.34%)
         occurrences all number
    15
    22
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    24 / 249 (9.64%)
    24 / 268 (8.96%)
         occurrences all number
    32
    36
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    52 / 249 (20.88%)
    57 / 268 (21.27%)
         occurrences all number
    54
    74
    Hypokalaemia
         subjects affected / exposed
    9 / 249 (3.61%)
    30 / 268 (11.19%)
         occurrences all number
    9
    32
    Hyperglycaemia
         subjects affected / exposed
    17 / 249 (6.83%)
    10 / 268 (3.73%)
         occurrences all number
    21
    19
    Hypomagnesaemia
         subjects affected / exposed
    9 / 249 (3.61%)
    16 / 268 (5.97%)
         occurrences all number
    15
    18

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2021
    - Changes made to align with the Health Authority Requirements - With cancellation of interim analysis, ORR was no longer a primary endpoint - BICR assessment added in alignment of Health Authority requirement - Clarified alpha allocation - Text added to update Sponsor’s position to not conduct interim analysis - Primary analysis of PFS was conducted on BICR assessment - All tumor-based endpoints were summarized based on both BICR and LIR
    23 Aug 2021
    - Change in Sponsor language throughout to reflect Immunomedics, Inc. is now part of the Gilead group of companies. - The Sponsor signature page was moved to Appendix 1 and other appendices have been re-numbered. - Abbreviations were added to the Schedule of Procedures table.

    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/37633306
    http://www.ncbi.nlm.nih.gov/pubmed/36027558
    http://www.ncbi.nlm.nih.gov/pubmed/32223649
    http://www.ncbi.nlm.nih.gov/pubmed/38748596
    http://www.ncbi.nlm.nih.gov/pubmed/38270051
    http://www.ncbi.nlm.nih.gov/pubmed/39067902
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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