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Trial record 40 of 173 for:    pertuzumab

A Study of Pertuzumab and Trastuzumab Subcutaneous (SC) Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (SAPPHIRE)

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ClinicalTrials.gov Identifier: NCT02019277
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : July 23, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Docetaxel
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Pertuzumab
Drug: Trastuzumab
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description Participants received first-line therapy with pertuzumab administered via intravenous (IV) infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 milligrams (mg), followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via subcutaneous (SC) injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until disease progression (PD), unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Period Title: Overall Study
Started 50
Completed 38
Not Completed 12
Reason Not Completed
Withdrawal by Subject             3
Death             7
Did no Cooperate             1
Adverse Event             1
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) population, which included all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
52.9  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
49
  98.0%
Male
1
   2.0%
1.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs) and Serious AEs
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs and SAEs was reported. AEs included both SAEs and non-SAEs. The 95% confidence interval (CI) was computed using Clopper-Pearson method.
Time Frame Baseline up to 28 days after last study drug administration (up to 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety population, which included all enrolled participants who received at least one dose of pertuzumab IV or trastuzumab SC.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
AEs
100.0
(92.9 to 100.0)
SAEs
54.0
(39.3 to 68.2)
2.Primary Outcome
Title Percentage of Participants With AEs by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 Intensity Grades
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of AEs were graded according to NCI CTCAE version 4.0 on a 5-point scale: Grade 1=Mild, intervention not indicated; Grade 2=Moderate, local or noninvasive intervention indicated; Grade 3=Severe or medically significant but not immediately life-threatening; Grade 4= Life-threatening consequences, urgent intervention indicated; and Grade 5=Death related to AE. Percentage of participants with AEs by maximum severity grades was reported.
Time Frame Baseline up to 28 days after last study drug administration (up to 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 4.0
Grade 2 32.0
Grade 3 50.0
Grade 4 12.0
Grade 5 2.0
3.Primary Outcome
Title Percentage of Participants With AEs Leading to Premature Discontinuation of Investigational Medicinal Products (IMPs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs leading to premature discontinuation of IMPs (pertuzumab and trastuzumab) was reported. AEs included both SAEs and non-SAEs. The 95% CI was computed using Clopper-Pearson method.
Time Frame Baseline up to 28 days after last study drug administration (up to 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.0
(4.5 to 24.3)
4.Primary Outcome
Title Percentage of Participants With AEs of Suspected Cardiac Origin, by New York Heart Association Classification (NYHA)
Hide Description NYHA functional classification includes: Class I (no limitation in physical activity; ordinary physical activity does not cause fatigue, breathlessness or palpitation), Class II (slight limitation of physical activity; ordinary physical activity results in fatigue, palpitation, breathlessness or angina pectoris), Class III (marked limitation of physical activity; less than ordinary activity will lead to symptomatically 'moderate' heart failure) and Class IV (inability to carry out any physical activity without discomfort; symptoms of congestive cardiac failure are present even at rest). Percentage of participants with AEs suspected to be of cardiac origin by maximum NYHA classification was reported.
Time Frame Baseline up to 28 days after last study drug administration (up to 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
Class I 6.0
Class II 4.0
Class III 2.0
Class IV 0.0
5.Primary Outcome
Title Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Below 50%
Hide Description LVEF was assessed using echocardiography (ECHO) or multiple-gated acquisition (MUGA) scans. Percentage of participants with LVEF below 50% at any time during the study was reported.
Time Frame Baseline up to 28 days after last study drug administration (up to 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
8.0
6.Secondary Outcome
Title Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Hide Description BOR was defined as a confirmed CR or PR. All measurable lesions up to a maximum of 2 lesions per organ and 5 in total were identified as target lesions (TLs) and recorded at baseline. A sum of the diameters (longest for non-nodal lesions, short axis [SA] for nodal lesions) for all TLs was calculated as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs and were recorded at baseline. CR was defined as the disappearance of all TLs and SA reduction to less than (<) 10 millimeter (mm) for nodal TLs/ non-TLs. PR was defined as greater than or equal to (>/=) 30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. The 95% CI was computed using Clopper-Pearson method.
Time Frame Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Only participants with measurable disease at baseline were included in the analysis. Participants without a post-baseline tumor assessment were considered non-responders.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.3
(58.1 to 85.4)
7.Secondary Outcome
Title Percentage of Participants With PD (Assessed According to RECIST Version 1.1) or Death Due to Any Cause
Hide Description For TLs, PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD, taking as reference the smallest SD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time Frame Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
60.0
8.Secondary Outcome
Title Progression-free Survival (PFS) Assessed According to RECIST Version 1.1
Hide Description PFS was defined as the time from start of treatment until first documented PD or death from any cause, whichever occurred first. Participants without PD, death, or who were lost to follow-up at the time of analysis were censored at the date of the last tumor assessment when non-progression was documented or at the last date of follow-up, whichever was last. Participants without tumor assessment data after the baseline were censored at baseline unless death occurred before first scheduled tumor assessment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, and/or unequivocal progression of existing non-TLs, or appearance of 1 or more new lesions. Median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.
Time Frame Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
17.02
(12.48 to 31.18)
9.Secondary Outcome
Title Percentage of Participants Who Died Due to Any Cause
Hide Description Percentage of participants who died due to any cause during the study was reported.
Time Frame Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
18.0
10.Secondary Outcome
Title Overall Survival (OS)
Hide Description The OS was defined as the time from the start of treatment until death from any cause. Participants alive at the time of analysis and participants who were lost to follow-up were censored at their last clinical assessment date. Median OS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.
Time Frame Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(31.28 to NA)
[1]
Median and Upper Limit for 95% CI could not be estimated due to high number of censored participants.
11.Secondary Outcome
Title Event-free Survival (EFS) Assessed According to RECIST Version 1.1
Hide Description EFS was defined as the time from the start of treatment until the first documented initiation of non-protocol-specified treatment for metastatic breast cancer, PD, or death from any cause, whichever occurred first. Participants without treatment change, PD, death, or who were lost to follow-up at the time of analysis were censored at the date of the last tumor assessment when non-progression was documented or at the last date of follow-up, whichever was last. Participants without tumor assessment after baseline were censored at baseline unless death occurred before first scheduled tumor assessment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, and/or unequivocal progression of existing non-TLs, or appearance of 1 or more new lesions. Median EFS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.
Time Frame Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
17.02
(12.48 to 31.18)
12.Secondary Outcome
Title Percentage of Participants Who Died During Receiving Second-Line of Treatment
Hide Description Percentage of participants who died from any cause during second-line of treatment was reported.
Time Frame From start of second-line of treatment (any time from baseline up to 35 months) up to death due to any cause or study end (up to approximately 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population participants who started second-line of treatment.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of participants
30.0
13.Secondary Outcome
Title OS During Second-Line of Treatment
Hide Description The OS during second-line therapy was defined as the time from the start of second-line therapy (failure of first-line therapy) until death from any cause. Participants alive at the time of analysis and participants who were lost to follow-up were censored at their last clinical assessment date. Median OS during second-line therapy was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.
Time Frame From start of second-line of treatment (any time from baseline up to 35 months) up to death due to any cause or study end (up to approximately 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population participants who started second-line of treatment.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
21.29
(14.85 to 29.04)
14.Secondary Outcome
Title Number of Participants Receiving Second-Line Treatment by Treatment Type
Hide Description Second-line anti-cancer treatment was initiated after disease progression on first-line therapy. Number of participants who started second-line of treatment by treatment type was reported. Participants who received combination treatment were counted for each treatment type.
Time Frame Baseline up to approximately 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population participants who started second-line of treatment.
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description:
Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Capecitabine 8
Cyclophosphamide 2
Denosumab 2
Doxorubicin 1
Epirubicin 1
Eribulin 1
Fluorouracil 1
Lapatinib 4
Nanoparticle Paclitaxel 1
Paclitaxel 4
Pertuzumab 5
Trastuzumab 13
Trastuzumab Emtansine 10
Vinorelbine 1
Time Frame Baseline up to 28 days after last study drug administration (up to 36 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trastuzumab, Pertuzumab, and Taxane
Hide Arm/Group Description Participants received first-line therapy with pertuzumab administered via IV infusion on Day 1 of first treatment cycle (1 cycle = 21 days) at a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle; trastuzumab administered via SC injection at a dose of 600 mg on Day 2 of first treatment cycle, and on Day 1 of each subsequent cycle if both pertuzumab and trastuzumab were well tolerated in Cycle 1; and taxane treatment (docetaxel, paclitaxel, or nabpaclitaxel), administered at the discretion of the investigator, per routine clinical practices and local prescribing instructions. Participants continued study treatment until PD, unacceptable toxicity, or withdrawal of consent. Participants with unacceptable toxicity or PD were switched to standard treatment of the investigator’s choice. All participants were followed-up until withdrawal of consent, loss to follow-up, death, or study closure.
All-Cause Mortality
Trastuzumab, Pertuzumab, and Taxane
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Trastuzumab, Pertuzumab, and Taxane
Affected / at Risk (%)
Total   27/50 (54.00%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  4/50 (8.00%) 
Anaemia * 1  1/50 (2.00%) 
Neutropenia * 1  1/50 (2.00%) 
Cardiac disorders   
Cardiac failure * 1  1/50 (2.00%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/50 (2.00%) 
Gastritis * 1  1/50 (2.00%) 
Nausea * 1  1/50 (2.00%) 
Oesophagitis * 1  1/50 (2.00%) 
General disorders   
Pyrexia * 1  7/50 (14.00%) 
Mucosal inflammation * 1  1/50 (2.00%) 
Immune system disorders   
Drug hypersensitivity * 1  1/50 (2.00%) 
Infections and infestations   
Cellulitis * 1  2/50 (4.00%) 
Upper respiratory tract infection * 1  2/50 (4.00%) 
Device related infection * 1  1/50 (2.00%) 
Gastroenteritis * 1  1/50 (2.00%) 
Sepsis * 1  1/50 (2.00%) 
Urinary tract infection * 1  1/50 (2.00%) 
Wound infection * 1  1/50 (2.00%) 
Injury, poisoning and procedural complications   
Femur fracture * 1  1/50 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  1/50 (2.00%) 
Nervous system disorders   
Syncope * 1  1/50 (2.00%) 
Psychiatric disorders   
Anxiety * 1  1/50 (2.00%) 
Depression * 1  1/50 (2.00%) 
Psychotic disorder * 1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism * 1  2/50 (4.00%) 
Dyspnoea * 1  1/50 (2.00%) 
Skin and subcutaneous tissue disorders   
Dermatitis bullous * 1  1/50 (2.00%) 
Dermatomyositis * 1  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab, Pertuzumab, and Taxane
Affected / at Risk (%)
Total   49/50 (98.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  4/50 (8.00%) 
Neutropenia * 1  8/50 (16.00%) 
Cardiac disorders   
Tachycardia * 1  3/50 (6.00%) 
Eye disorders   
Dry eye * 1  6/50 (12.00%) 
Lacrimation increased * 1  4/50 (8.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  5/50 (10.00%) 
Abdominal pain upper * 1  3/50 (6.00%) 
Constipation * 1  9/50 (18.00%) 
Diarrhoea * 1  35/50 (70.00%) 
Dry mouth * 1  3/50 (6.00%) 
Dyspepsia * 1  3/50 (6.00%) 
Gastrooesophageal reflux disease * 1  12/50 (24.00%) 
Nausea * 1  23/50 (46.00%) 
Stomatitis * 1  6/50 (12.00%) 
Vomiting * 1  17/50 (34.00%) 
General disorders   
Chest discomfort * 1  3/50 (6.00%) 
Chest pain * 1  3/50 (6.00%) 
Chills * 1  4/50 (8.00%) 
Fatigue * 1  34/50 (68.00%) 
Injection site reaction * 1  3/50 (6.00%) 
Mucosal inflammation * 1  5/50 (10.00%) 
Oedema peripheral * 1  4/50 (8.00%) 
Pain * 1  3/50 (6.00%) 
Infections and infestations   
Conjunctivitis * 1  3/50 (6.00%) 
Nail infection * 1  3/50 (6.00%) 
Oral candidiasis * 1  4/50 (8.00%) 
Paronychia * 1  7/50 (14.00%) 
Rash pustular * 1  4/50 (8.00%) 
Sinusitis * 1  4/50 (8.00%) 
Upper respiratory tract infection * 1  19/50 (38.00%) 
Urinary tract infection * 1  10/50 (20.00%) 
Investigations   
Weight decreased * 1  3/50 (6.00%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  6/50 (12.00%) 
Hypocalcaemia * 1  3/50 (6.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  12/50 (24.00%) 
Back pain * 1  10/50 (20.00%) 
Bone pain * 1  3/50 (6.00%) 
Muscle spasms * 1  14/50 (28.00%) 
Musculoskeletal chest pain * 1  3/50 (6.00%) 
Musculoskeletal pain * 1  6/50 (12.00%) 
Myalgia * 1  18/50 (36.00%) 
Pain in extremity * 1  11/50 (22.00%) 
Nervous system disorders   
Dizziness * 1  9/50 (18.00%) 
Dysgeusia * 1  7/50 (14.00%) 
Headache * 1  17/50 (34.00%) 
Lethargy * 1  5/50 (10.00%) 
Neuropathy peripheral * 1  28/50 (56.00%) 
Peripheral sensory neuropathy * 1  5/50 (10.00%) 
Psychiatric disorders   
Anxiety * 1  4/50 (8.00%) 
Depression * 1  3/50 (6.00%) 
Insomnia * 1  6/50 (12.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  9/50 (18.00%) 
Dyspnoea * 1  6/50 (12.00%) 
Dyspnoea exertional * 1  3/50 (6.00%) 
Epistaxis * 1  12/50 (24.00%) 
Oropharyngeal pain * 1  7/50 (14.00%) 
Rhinorrhoea * 1  4/50 (8.00%) 
Skin and subcutaneous tissue disorders   
Acne * 1  4/50 (8.00%) 
Alopecia * 1  27/50 (54.00%) 
Dermatitis acneiform * 1  3/50 (6.00%) 
Dry skin * 1  8/50 (16.00%) 
Erythema * 1  4/50 (8.00%) 
Nail disorder * 1  12/50 (24.00%) 
Pruritus * 1  7/50 (14.00%) 
Rash * 1  26/50 (52.00%) 
Skin lesion * 1  3/50 (6.00%) 
Surgical and medical procedures   
Tooth extraction * 1  3/50 (6.00%) 
Vascular disorders   
Hot flush * 1  7/50 (14.00%) 
Hypertension * 1  6/50 (12.00%) 
Lymphoedema * 1  3/50 (6.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02019277     History of Changes
Other Study ID Numbers: ML28784
First Submitted: December 18, 2013
First Posted: December 24, 2013
Results First Submitted: October 10, 2017
Results First Posted: July 23, 2018
Last Update Posted: September 13, 2018