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    Clinical Trial Results:
    A Multicenter, Open-Label, Single-Arm Safety Study of Herceptin SC In Combination With Perjeta and Docetaxel in Treatment of Patients With HER2-Positive Advanced Breast Cancer (Metastatic or Locally Recurrent).

    Summary
    EudraCT number
    		 2014-001458-40
    Trial protocol
    		 PT   GB   IT   ES   HU   BE   DE   FR   BG   PL  
    Global end of trial date
    22 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Mar 2020
    First version publication date
    05 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BO29159
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02402712
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche, Ltd.
    Sponsor organisation address
    Grenzarcherstrasse 124, Basel, Switzerland, 4070
    Public contact
    F. Hoffmann-La Roche, Ltd., Roche Trial Information Hotline, +41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.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
    22 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    An open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer.
    Protection of trial subjects
    This study was conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. All study subjects were required to read and sign and informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 18
    Country: Number of subjects enrolled
    Bulgaria: 5
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Spain: 31
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    United Kingdom: 45
    Country: Number of subjects enrolled
    Hungary: 43
    Country: Number of subjects enrolled
    Italy: 81
    Country: Number of subjects enrolled
    Mexico: 44
    Country: Number of subjects enrolled
    Poland: 82
    Country: Number of subjects enrolled
    Portugal: 21
    Worldwide total number of subjects
    418
    EEA total number of subjects
    373
    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)
    315
    From 65 to 84 years
    103
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (metastatic or locally recurrent) who had not previously received systemic non-hormonal anti-cancer therapy in the metastatic setting.

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

    Arms
    Arm title
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Arm description
    		 Single arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Herceptin SC
    Investigational medicinal product code
    Other name
    Trastuzumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Fixed dose of 600 mg/5 mL administered as a subcutaneous (SC) injection into the thigh on Day 1 of each cycle every 3 weeks (Q3W) throughout the treatment phase.

    Investigational medicinal product name
    Perjeta IV
    Investigational medicinal product code
    Other name
    Pertuzumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as an intravenous (IV) infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle Q3W throughout the treatment phase. Perjeta IV was administered 60 minutes after the end of Herceptin SC administration.

    Investigational medicinal product name
    Docetaxel IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered after Herceptin SC and Perjeta IV on Day 1 at a recommended initial dose of 75 mg/m2, of each cycle Q3W throughout the treatment phase. After Cycle 6, continuation of docetaxel treatment was at the discretion of the treating physician in agreement with the patient. The dose of docetaxel could be escalated to 100 mg/m2 at the investigator’s discretion on subsequent cycles if the initial dose is well tolerated.

    Number of subjects in period 1
    		Herceptin SC + Perjeta IV + Docetaxel IV
    Started
    418
    Received Study Drug
    412
    Completed
    276
    Not completed
    142
         Withdrawal By Subject
    43
         Other
    3
         Death
    87
         Lost to follow-up
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Herceptin SC + Perjeta IV + Docetaxel IV
    Reporting group description
    		 Single arm

    Reporting group values
    		 Herceptin SC + Perjeta IV + Docetaxel IV Total
    Number of subjects
    		 418 418
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 315 315
        From 65-84 years
    		 103 103
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.6 ± 11.7 -
    Gender categorical
    Units: Subjects
        Female
    		 418 418
        Male
    		 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 26 26
        Asian
    		 3 3
        Black or African American
    		 8 8
        White
    		 352 352
        Multiple
    		 2 2
        Unknown
    		 27 27
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 69 69
        Not Hispanic or Latino
    		 309 309
        Not Stated
    		 28 28
        Unknown
    		 12 12
    Subject analysis sets

    Subject analysis set title
    Herceptin SC + Perjeta IV + Docetaxel IV
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety-Evaluable Subjects

    Subject analysis sets values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects
    412
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    310
        From 65-84 years
    102
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.6 ± 11.7
    Gender categorical
    Units: Subjects
        Female
    412
        Male
    0
    Race
    Units: Subjects
        American Indian or Alaska Native
    26
        Asian
    2
        Black or African American
    8
        White
    347
        Multiple
    2
        Unknown
    27
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    69
        Not Hispanic or Latino
    305
        Not Stated
    27
        Unknown
    11

    End points

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    End points reporting groups
    Reporting group title
    Herceptin SC + Perjeta IV + Docetaxel IV
    Reporting group description
    		 Single arm

    Subject analysis set title
    Herceptin SC + Perjeta IV + Docetaxel IV
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety-Evaluable Subjects

    Primary: Number of Subjects with at Least one Adverse Event (AEs)

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    End point title
    		 Number of Subjects with at Least one Adverse Event (AEs) [1]
    End point description
    According to the ICH guideline for Good Clinical Practice, an adverse event is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution.
    End point type
    Primary
    End point timeframe
    Up to 24 months after the last subject has been enrolled, approximately 3.5 years
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary objective for this study is to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in patients with HER2−positive advanced (metastatic or locally recurrent) breast cancer. As there is only one treatment group in this study, no comparisons were done, and thus descriptive statistics (numbers of patients and percentages) were used to summarize results.
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    412
    Units: Subjects
    406
    No statistical analyses for this end point

    Primary: Number of Subjects with at Least one Adverse Events Grade ≥3, According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0

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    End point title
    		 Number of Subjects with at Least one Adverse Events Grade ≥3, According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 [2]
    End point description
    Adverse events Grade ≥ 3 for the treatment of Herceptin SC in combination with Perjeta IV, and Docetaxel IV
    End point type
    Primary
    End point timeframe
    Up to 24 months after the last subject has been enrolled, approximately 3.5 years
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary objective for this study is to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in patients with HER2−positive advanced (metastatic or locally recurrent) breast cancer. As there is only one treatment group in this study, no comparisons were done, and thus descriptive statistics (numbers of patients and percentages) were used to summarize results.
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    412
    Units: Subjects
    221
    No statistical analyses for this end point

    Primary: Number of Subjects with Cardiac Adverse Events, Congestive Heart Failure (CHF), and Cardiac Death

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    End point title
    		 Number of Subjects with Cardiac Adverse Events, Congestive Heart Failure (CHF), and Cardiac Death [3]
    End point description
    Cardiac adverse events, defined as one of the following: All-grade adverse events within the System Organ Class (SOC) of Cardiac Disorders, Grade ≥3 cardiac adverse events according to NCI CTCAE v4.0 within the SOC of Cardiac Disorders, serious cardiac adverse events within the SOC of Cardiac Disorders, serious adverse events suggestive of CHF defined by any adverse events within the standardized MedDRA query (SMQ) of cardiac failure (wide), CHF assessed by the investigator using NCI CTCAE grades and New York Heart Association class (MedDRA preferred term), Cardiac deaths defined as deaths caused by an event within the SOC of Cardiac Disorders
    End point type
    Primary
    End point timeframe
    Up to 24 months after the last patient has been enrolled, approximately 3.5 years
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary objective for this study is to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in patients with HER2−positive advanced (metastatic or locally recurrent) breast cancer. As there is only one treatment group in this study, no comparisons were done, and thus descriptive statistics (numbers of patients and percentages) were used to summarize results.
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    412
    Units: Subjects
        All-grade AEs within the SOC Cardiac Disorders
    33
        Grade ≥3 AEs within the SOC Cardiac Disorders
    3
        Serious AEs within the SOC Cardiac Disorders
    4
        Serious AE suggesting CHF
    1
        Cardiac Death
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Significant Decrease in LVEF (≥10 Percentage Points from Baseline to LVEF <50%)

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    End point title
    		 Number of Subjects with Significant Decrease in LVEF (≥10 Percentage Points from Baseline to LVEF <50%) [4]
    End point description
    Significant Decrease in LVEF ≥10% Percentage Points from Baseline to LVEF <50%
    End point type
    Primary
    End point timeframe
    Up to 24 months after last subject enrolled, approximately 3.5 years
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary objective for this study is to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in patients with HER2−positive advanced (metastatic or locally recurrent) breast cancer. As there is only one treatment group in this study, no comparisons were done, and thus descriptive statistics (numbers of patients and percentages) were used to summarize results.
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    396
    Units: Subjects
    40
    No statistical analyses for this end point

    Secondary: Progression-Free Survival, Tumor Assessments According to RECIST v1.1

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    End point title
    		 Progression-Free Survival, Tumor Assessments According to RECIST v1.1
    End point description
    Kaplan-Meier Event-Free Rates for Progression-Free Survival Over Time
    End point type
    Secondary
    End point timeframe
    6 months, 12 months, 18 months, 24 months
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    412
    Units: Percentage
    arithmetic mean (confidence interval 95%)
        6 Months
    86.47 (83.11 to 89.83)
        12 Months
    64.13 (59.34 to 68.92)
        18 Months
    51.47 (46.44 to 56.50)
        24 Months
    42.47 (37.42 to 47.53)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Kaplan-Meier Event-Free Rates for Overall Survival Over Time
    End point type
    Secondary
    End point timeframe
    6 months, 12 months, 18 months, 24 months
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    412
    Units: Percentage
    arithmetic mean (confidence interval 95%)
        6 Months
    97.29 (95.70 to 98.87)
        12 Months
    92.89 (90.35 to 95.43)
        18 months
    86.79 (83.41 to 90.17)
        24 months
    81.13 (77.19 to 85.06)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR), Defined as a Complete Response (CR) or a Partial Response (PR)

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    End point title
    		 Objective Response Rate (ORR), Defined as a Complete Response (CR) or a Partial Response (PR)
    End point description
    ORR is defined as a complete response or partial response determined by the investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart. Subjects with disease localized only to the bone will not be included in the analysis of objective response. Only subjects with measurable disease at baseline will be included in the analysis of objective response. An estimate of the ORR and its two-sided 95% CI according to Pearson Clopper is calculated.
    End point type
    Secondary
    End point timeframe
    Up to 3.5 years
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    336
    Units: Percentage
        arithmetic mean (confidence interval 95%)
    75.6 (70.64 to 80.09)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Anti-Herceptin Antibodies at Baseline

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    End point title
    		 Percentage of Subjects with Anti-Herceptin Antibodies at Baseline
    End point description
    Percentage of subjects anti-drug antibody (ADA)-positive at baseline
    End point type
    Secondary
    End point timeframe
    Up to 3.5 years
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    398
    Units: Percentage
        number (not applicable)
    14.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-Emergent Anti-Herceptin Antibodies

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    End point title
    		 Percentage of Subjects with Treatment-Emergent Anti-Herceptin Antibodies
    End point description
    Percentage of subjects ADA-positive post-baseline
    End point type
    Secondary
    End point timeframe
    Up to 3.5 years
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    396
    Units: Percentage
        number (not applicable)
    24
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Anti-rHuPH20 Antibodies at Baseline

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    End point title
    		 Percentage of Subjects with Anti-rHuPH20 Antibodies at Baseline
    End point description
    Percentage of subjects ADA-positive at baseline
    End point type
    Secondary
    End point timeframe
    Up to 3.5 years
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    399
    Units: Percentage
        number (not applicable)
    6.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-Emergent Anti-rHuPH20 Antibodies

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    End point title
    		 Percentage of Subjects with Treatment-Emergent Anti-rHuPH20 Antibodies
    End point description
    Percentage of subjects ADA-positive post-baseline
    End point type
    Secondary
    End point timeframe
    Up to 3.5 years
    End point values
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Number of subjects analysed
    396
    Units: Percentage
        number (not applicable)
    2.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 months after the last patient has been enrolled, approximately 3.5 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Herceptin SC + Perjeta IV + Docetaxel IV
    Reporting group description
    		 -

    Serious adverse events
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    107 / 412 (25.97%)
         number of deaths (all causes)
    87
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphocytic leukaemia
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Tumour haemorrhage
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hypertension
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    4 / 412 (0.97%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    1 / 4
    Pyrexia
         subjects affected / exposed
    3 / 412 (0.73%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    4 / 412 (0.97%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood electrolytes decreased
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Incisional hernia, obstructive
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ventricular hypokinesia
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    3 / 412 (0.73%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    25 / 412 (6.07%)
         occurrences causally related to treatment / all
    26 / 26
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    4 / 412 (0.97%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    9 / 412 (2.18%)
         occurrences causally related to treatment / all
    8 / 10
         deaths causally related to treatment / all
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Breast abscess
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mastitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 412 (1.46%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 1
    Post procedural infection
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular device infection
         subjects affected / exposed
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Herceptin SC + Perjeta IV + Docetaxel IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    399 / 412 (96.84%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    23 / 412 (5.58%)
         occurrences all number
    25
    Hypertension
         subjects affected / exposed
    36 / 412 (8.74%)
         occurrences all number
    42
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    136 / 412 (33.01%)
         occurrences all number
    243
    Fatigue
         subjects affected / exposed
    94 / 412 (22.82%)
         occurrences all number
    128
    Mucosal inflammation
         subjects affected / exposed
    68 / 412 (16.50%)
         occurrences all number
    95
    Oedema peripheral
         subjects affected / exposed
    51 / 412 (12.38%)
         occurrences all number
    62
    Pyrexia
         subjects affected / exposed
    64 / 412 (15.53%)
         occurrences all number
    84
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    48 / 412 (11.65%)
         occurrences all number
    65
    Epistaxis
         subjects affected / exposed
    58 / 412 (14.08%)
         occurrences all number
    77
    Oropharyngeal pain
         subjects affected / exposed
    26 / 412 (6.31%)
         occurrences all number
    31
    Rhinorrhoea
         subjects affected / exposed
    30 / 412 (7.28%)
         occurrences all number
    34
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    35 / 412 (8.50%)
         occurrences all number
    40
    Investigations
    Ejection fraction decreased
         subjects affected / exposed
    48 / 412 (11.65%)
         occurrences all number
    60
    Weight decreased
         subjects affected / exposed
    23 / 412 (5.58%)
         occurrences all number
    25
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    65 / 412 (15.78%)
         occurrences all number
    90
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    34 / 412 (8.25%)
         occurrences all number
    38
    Headache
         subjects affected / exposed
    44 / 412 (10.68%)
         occurrences all number
    53
    Neuropathy peripheral
         subjects affected / exposed
    42 / 412 (10.19%)
         occurrences all number
    43
    Paraesthesia
         subjects affected / exposed
    37 / 412 (8.98%)
         occurrences all number
    45
    Taste disorder
         subjects affected / exposed
    26 / 412 (6.31%)
         occurrences all number
    28
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    75 / 412 (18.20%)
         occurrences all number
    83
    Leukopenia
         subjects affected / exposed
    29 / 412 (7.04%)
         occurrences all number
    36
    Neutropenia
         subjects affected / exposed
    71 / 412 (17.23%)
         occurrences all number
    104
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    64 / 412 (15.53%)
         occurrences all number
    76
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    26 / 412 (6.31%)
         occurrences all number
    33
    Abdominal pain upper
         subjects affected / exposed
    31 / 412 (7.52%)
         occurrences all number
    36
    Constipation
         subjects affected / exposed
    39 / 412 (9.47%)
         occurrences all number
    51
    Diarrhoea
         subjects affected / exposed
    259 / 412 (62.86%)
         occurrences all number
    575
    Dyspepsia
         subjects affected / exposed
    32 / 412 (7.77%)
         occurrences all number
    34
    Nausea
         subjects affected / exposed
    115 / 412 (27.91%)
         occurrences all number
    181
    Stomatitis
         subjects affected / exposed
    56 / 412 (13.59%)
         occurrences all number
    80
    Vomiting
         subjects affected / exposed
    56 / 412 (13.59%)
         occurrences all number
    90
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    193 / 412 (46.84%)
         occurrences all number
    197
    Dry skin
         subjects affected / exposed
    23 / 412 (5.58%)
         occurrences all number
    26
    Erythema
         subjects affected / exposed
    23 / 412 (5.58%)
         occurrences all number
    30
    Nail disorder
         subjects affected / exposed
    23 / 412 (5.58%)
         occurrences all number
    25
    Pruritus
         subjects affected / exposed
    47 / 412 (11.41%)
         occurrences all number
    56
    Rash
         subjects affected / exposed
    68 / 412 (16.50%)
         occurrences all number
    89
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    21 / 412 (5.10%)
         occurrences all number
    25
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    82 / 412 (19.90%)
         occurrences all number
    116
    Back pain
         subjects affected / exposed
    34 / 412 (8.25%)
         occurrences all number
    50
    Bone pain
         subjects affected / exposed
    33 / 412 (8.01%)
         occurrences all number
    37
    Muscle spasms
         subjects affected / exposed
    32 / 412 (7.77%)
         occurrences all number
    38
    Musculoskeletal pain
         subjects affected / exposed
    21 / 412 (5.10%)
         occurrences all number
    29
    Myalgia
         subjects affected / exposed
    49 / 412 (11.89%)
         occurrences all number
    68
    Pain in extremity
         subjects affected / exposed
    42 / 412 (10.19%)
         occurrences all number
    54
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    42 / 412 (10.19%)
         occurrences all number
    45
    Influenza
         subjects affected / exposed
    23 / 412 (5.58%)
         occurrences all number
    25
    Nasopharyngitis
         subjects affected / exposed
    36 / 412 (8.74%)
         occurrences all number
    48
    Rhinitis
         subjects affected / exposed
    21 / 412 (5.10%)
         occurrences all number
    25
    Upper respiratory tract infection
         subjects affected / exposed
    29 / 412 (7.04%)
         occurrences all number
    45
    Urinary tract infection
         subjects affected / exposed
    23 / 412 (5.58%)
         occurrences all number
    29
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    61 / 412 (14.81%)
         occurrences all number
    85
    Hypokalaemia
         subjects affected / exposed
    24 / 412 (5.83%)
         occurrences all number
    29

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2015
    Protocol BO29159 has been amended to correct a typographical error in one of exclusion criteria from “at least” to “less than.”

    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
    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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