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Trial record 34 of 168 for:    pertuzumab

A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer (VELVET)

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ClinicalTrials.gov Identifier: NCT01565083
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Pertuzumab
Drug: Trastuzumab
Drug: Vinorelbine
Enrollment 213
Recruitment Details  
Pre-assignment Details Due to non-randomized nature of the study (single infusion cohort started enrollment only after separate infusion cohort recruitment was completed) and different baseline characteristics of participants, the comparison between the 2 cohorts was not performed. Hence, the efficacy and safety results for the 2 cohorts should be considered separately.
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description Pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg per kilogram (mg/kg) on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg per meter-squared (mg/m^2) on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Period Title: Overall Study
Started 106 107
Completed 73 68
Not Completed 33 39
Reason Not Completed
Withdrawal by Subject             6             4
Lost to Follow-up             2             7
Death             22             23
Other             3             5
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion Total
Hide Arm/Group Description Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). Total of all reporting groups
Overall Number of Baseline Participants 106 107 213
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants enrolled into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 107 participants 213 participants
56.9  (11.80) 55.6  (13.17) 56.2  (12.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 107 participants 213 participants
Female
106
 100.0%
106
  99.1%
212
  99.5%
Male
0
   0.0%
1
   0.9%
1
   0.5%
1.Primary Outcome
Title Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Hide Description Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach.
Time Frame Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only participants with measurable disease at baseline were included in the analysis.
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 89 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.2
(63.8 to 82.9)
63.7
(53.0 to 73.6)
2.Secondary Outcome
Title Time to Response as Assessed by Investigator According to RECIST v 1.1
Hide Description For participants with a BOR of CR or PR, time to response = (Date of first confirmed CR/PR - Date of first study treatment) + 1. For participants without a CR or PR, time to response = (Date of adequate last tumor assessment - Date of first study treatment) + 1. For participant with no tumor assessment (or if all assessments were progressive disease [PD]) the censoring day was set to date of first study treatment +1. CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.
Time Frame Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only participants with measurable disease at baseline were included in the analysis.
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 89 91
Median (95% Confidence Interval)
Unit of Measure: months
2.1
(2.0 to 2.2)
2.2
(2.1 to 4.4)
3.Secondary Outcome
Title Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1
Hide Description DOR, in participants with a BOR of CR or PR, was defined as the period from the date of initial PR or CR until the date of PD or death from any cause. Participants with no documented PD or death after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively (regardless of the response at intermediate assessments). CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.
Time Frame Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only participants with a BOR of CR or PR and with measurable disease at baseline were included in the analysis.
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 66 58
Median (95% Confidence Interval)
Unit of Measure: months
13.3
(10.6 to 16.2)
11.8
(7.5 to 17.9)
4.Secondary Outcome
Title Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause
Hide Description 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, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause was reported.
Time Frame Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 106 107
Measure Type: Number
Unit of Measure: percentage of participants
69.8 67.3
5.Secondary Outcome
Title Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1
Hide Description PFS was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PFS events were censored at the time of the last evaluable tumor assessment. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or died due to any cause were considered as having an event. The median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.
Time Frame Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 106 107
Median (95% Confidence Interval)
Unit of Measure: months
14.3
(11.2 to 17.5)
11.5
(10.3 to 15.8)
6.Secondary Outcome
Title Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1
Hide Description 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, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 was reported.
Time Frame Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 106 107
Measure Type: Number
Unit of Measure: percentage of participants
67.9 61.7
7.Secondary Outcome
Title Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1
Hide Description TTP was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1. Participants who did not have a radio-graphically documented PD and had died due to reason other than PD were censored on the last available tumor assessment prior to the death date. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. 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, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 were considered as having an event. The median TTP was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.
Time Frame Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 106 107
Median (95% Confidence Interval)
Unit of Measure: months
14.9
(11.3 to 17.9)
12.8
(10.4 to 17.1)
8.Secondary Outcome
Title Percentage of Participants Who Died From Any Cause
Hide Description Percentage of participants who died due to any cause was reported.
Time Frame Baseline until death (up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 106 107
Measure Type: Number
Unit of Measure: percentage of participants
21.7 21.5
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from first intake of any study medication to the date of death, regardless of the cause of death. Participants who were known to be alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study treatment, and participants with no post-baseline information were censored at the date of first study treatment plus 1 day. Participants who died due to any cause were considered as having an event. The median OS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.
Time Frame Baseline until death (up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 106 107
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and corresponding CI could not be calculated due to low number of participants who had an event.
10.Secondary Outcome
Title Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score
Hide Description EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time Frame Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)
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Hide Analysis Population Description
ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 102 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n = 102, 102) 69.7  (22.74) 68.6  (23.58)
Change at Cycle 3 (n = 83, 90) 0.9  (19.31) 1.7  (23.16)
Change at Cycle 6 (n=68, 82) 1.0  (23.59) 4.3  (24.49)
Change at Cycle 9 (n=67, 68) 2.2  (23.00) 6.6  (26.29)
Change at Cycle 12 (n=53, 59) -1.4  (30.19) 6.8  (23.59)
Change at Cycle 15 (n=43, 43) 6.3  (19.34) 8.1  (24.45)
Change at Cycle 18 (n=32, 28) 5.7  (21.83) 6.5  (22.12)
Change at Cycle 21 (n=30, 27) 3.2  (20.00) 1.3  (28.50)
Change at Cycle 24 (n=25, 26) 3.1  (17.06) 2.8  (23.16)
Change at Cycle 27 (n=21, 24) 5.9  (18.79) 1.1  (20.16)
Change at Cycle 30 (n=18, 19) 5.4  (19.87) 9.5  (19.68)
Change at Cycle 33 (n=15, 15) 2.9  (24.03) 13.4  (19.65)
Change at Cycle 36 (n=14, 7) 4.8  (17.37) 7.3  (21.72)
Change at Cycle 39 (n=6, 1) 15.8  (19.85) 50.0 [1]   (NA)
Change at Cycle 42 (n=2, 0) -5.0  (14.14) NA [2]   (NA)
Change at Cycle 45 (n=1, 0) 5.0 [1]   (NA) NA [2]   (NA)
[1]
Standard deviation data was not available because only 1 participant was evaluable at indicated time point.
[2]
Data was not available because no participant was evaluable at indicated time point.
11.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Hide Description FACT-B questionnaire is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time Frame Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)
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Hide Analysis Population Description
ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description:
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Overall Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n = 100, 100) 76.7  (13.46) 78.5  (16.06)
Change at Cycle 3 (n = 82, 90) -1.96  (10.872) -2.57  (13.159)
Change at Cycle 6 (n=70, 79) -0.97  (12.749) 0.47  (13.724)
Change at Cycle 9 (n=65, 60) 1.44  (13.189) -0.42  (14.602)
Change at Cycle 12 (n=52, 51) 0.40  (12.057) 0.51  (14.510)
Change at Cycle 15 (n=43, 44) 2.72  (10.989) 0.09  (13.713)
Change at Cycle 18 (n=32, 32) 4.58  (11.801) 0.51  (16.512)
Change at Cycle 21 (n=29, 24) 3.22  (13.178) -0.23  (16.116)
Change at Cycle 24 (n= 26, 23) 1.19  (10.660) -1.03  (14.546)
Change at Cycle 27 (n=20, 22) 4.91  (9.900) 0.55  (14.185)
Change at Cycle 30 (n=18, 24) 3.96  (11.082) -0.26  (17.381)
Change at Cycle 33 (n=14, 17) 5.75  (13.272) 1.76  (19.179)
Change at Cycle 36 (n=15, 13) 1.26  (9.210) 2.74  (14.354)
Change at Cycle 39 (n=6, 6) -3.68  (16.866) 7.33  (20.992)
Change at Cycle 42 (n=4, 0) -0.17  (10.599) NA [1]   (NA)
Change at Cycle 45 (n=1, 0) 1.00 [2]   (NA) NA [1]   (NA)
[1]
Data was not available because no participant was evaluable at indicated time point.
[2]
Standard deviation data was not available because only 1 participant was evaluable at indicated time point.
Time Frame Day 1 until 28 days after last study treatment (up to approximately 3.5 years)
Adverse Event Reporting Description Treatment-emergent adverse events (TEAEs) are adverse events occurring between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Safety Population included all participants who received at least one dose of any study treatment in any of the 2 cohorts.
 
Arm/Group Title Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Hide Arm/Group Description Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
All-Cause Mortality
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   32/106 (30.19%)   44/107 (41.12%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  6/106 (5.66%)  3/107 (2.80%) 
Leukopenia * 1  1/106 (0.94%)  0/107 (0.00%) 
Neutropenia * 1  1/106 (0.94%)  3/107 (2.80%) 
Cardiac disorders     
Arrhythmia * 1  1/106 (0.94%)  0/107 (0.00%) 
Atrial fibrillation * 1  0/106 (0.00%)  1/107 (0.93%) 
Cardiac failure * 1  0/106 (0.00%)  1/107 (0.93%) 
Left ventricular dysfunction * 1  1/106 (0.94%)  0/107 (0.00%) 
Myocardial infarction * 1  1/106 (0.94%)  0/107 (0.00%) 
Supraventricular tachycardia * 1  0/106 (0.00%)  1/107 (0.93%) 
Tachycardia * 1  0/106 (0.00%)  1/107 (0.93%) 
Gastrointestinal disorders     
Abdominal hernia obstructive * 1  0/106 (0.00%)  1/107 (0.93%) 
Abdominal pain * 1  2/106 (1.89%)  0/107 (0.00%) 
Constipation * 1  1/106 (0.94%)  0/107 (0.00%) 
Diarrhoea * 1  1/106 (0.94%)  1/107 (0.93%) 
Gastric ulcer haemorrhage * 1  0/106 (0.00%)  1/107 (0.93%) 
Intestinal obstruction * 1  0/106 (0.00%)  2/107 (1.87%) 
Nausea * 1  0/106 (0.00%)  2/107 (1.87%) 
Oesophagitis * 1  0/106 (0.00%)  1/107 (0.93%) 
Pancreatitis acute * 1  1/106 (0.94%)  0/107 (0.00%) 
General disorders     
Fatigue * 1  0/106 (0.00%)  1/107 (0.93%) 
Malaise * 1  1/106 (0.94%)  1/107 (0.93%) 
Pyrexia * 1  2/106 (1.89%)  6/107 (5.61%) 
Immune system disorders     
Drug hypersensitivity * 1  2/106 (1.89%)  0/107 (0.00%) 
Hypersensitivity * 1  5/106 (4.72%)  0/107 (0.00%) 
Infections and infestations     
Device related infection * 1  1/106 (0.94%)  2/107 (1.87%) 
Erysipelas * 1  0/106 (0.00%)  1/107 (0.93%) 
Gastroenteritis * 1  0/106 (0.00%)  1/107 (0.93%) 
Implant site infection * 1  0/106 (0.00%)  1/107 (0.93%) 
Influenza * 1  1/106 (0.94%)  0/107 (0.00%) 
Meningitis * 1  0/106 (0.00%)  1/107 (0.93%) 
Nosocomial infection * 1  1/106 (0.94%)  0/107 (0.00%) 
Pneumonia * 1  2/106 (1.89%)  4/107 (3.74%) 
Sepsis * 1  0/106 (0.00%)  1/107 (0.93%) 
Septic shock * 1  2/106 (1.89%)  1/107 (0.93%) 
Urinary tract infection * 1  1/106 (0.94%)  0/107 (0.00%) 
Injury, poisoning and procedural complications     
Femoral neck fracture * 1  0/106 (0.00%)  1/107 (0.93%) 
Femur fracture * 1  0/106 (0.00%)  1/107 (0.93%) 
Infusion related reaction * 1  1/106 (0.94%)  0/107 (0.00%) 
Wound dehiscence * 1  0/106 (0.00%)  1/107 (0.93%) 
Investigations     
Blood creatine phosphokinase increased * 1  0/106 (0.00%)  1/107 (0.93%) 
Ejection fraction decreased * 1  1/106 (0.94%)  1/107 (0.93%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  0/106 (0.00%)  1/107 (0.93%) 
Musculoskeletal and connective tissue disorders     
Osteonecrosis of jaw * 1  0/106 (0.00%)  1/107 (0.93%) 
Pathological fracture * 1  0/106 (0.00%)  1/107 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastrointestinal stromal tumour * 1  0/106 (0.00%)  1/107 (0.93%) 
Malignant melanoma * 1  0/106 (0.00%)  1/107 (0.93%) 
Neuroendocrine tumour * 1  0/106 (0.00%)  1/107 (0.93%) 
Nervous system disorders     
Paraparesis * 1  1/106 (0.94%)  0/107 (0.00%) 
Sensorimotor disorder * 1  1/106 (0.94%)  0/107 (0.00%) 
Syncope * 1  0/106 (0.00%)  1/107 (0.93%) 
Psychiatric disorders     
Depression * 1  0/106 (0.00%)  1/107 (0.93%) 
Psychotic disorder * 1  0/106 (0.00%)  1/107 (0.93%) 
Renal and urinary disorders     
Acute kidney injury * 1  1/106 (0.94%)  0/107 (0.00%) 
Haematuria * 1  0/106 (0.00%)  1/107 (0.93%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  1/106 (0.94%)  0/107 (0.00%) 
Interstitial lung disease * 1  1/106 (0.94%)  0/107 (0.00%) 
Pleural effusion * 1  0/106 (0.00%)  2/107 (1.87%) 
Pulmonary embolism * 1  1/106 (0.94%)  2/107 (1.87%) 
Vascular disorders     
Deep vein thrombosis * 1  1/106 (0.94%)  1/107 (0.93%) 
Jugular vein thrombosis * 1  0/106 (0.00%)  1/107 (0.93%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   103/106 (97.17%)   106/107 (99.07%) 
Blood and lymphatic system disorders     
Anaemia * 1  36/106 (33.96%)  19/107 (17.76%) 
Leukopenia * 1  24/106 (22.64%)  16/107 (14.95%) 
Neutropenia * 1  54/106 (50.94%)  61/107 (57.01%) 
Cardiac disorders     
Tachycardia * 1  3/106 (2.83%)  7/107 (6.54%) 
Eye disorders     
Cataract * 1  2/106 (1.89%)  6/107 (5.61%) 
Lacrimation increased * 1  6/106 (5.66%)  6/107 (5.61%) 
Gastrointestinal disorders     
Abdominal pain * 1  15/106 (14.15%)  19/107 (17.76%) 
Abdominal pain upper * 1  20/106 (18.87%)  22/107 (20.56%) 
Constipation * 1  35/106 (33.02%)  35/107 (32.71%) 
Diarrhoea * 1  61/106 (57.55%)  62/107 (57.94%) 
Dry mouth * 1  2/106 (1.89%)  7/107 (6.54%) 
Dyspepsia * 1  7/106 (6.60%)  15/107 (14.02%) 
Haemorrhoids * 1  9/106 (8.49%)  4/107 (3.74%) 
Nausea * 1  52/106 (49.06%)  44/107 (41.12%) 
Stomatitis * 1  19/106 (17.92%)  26/107 (24.30%) 
Vomiting * 1  34/106 (32.08%)  25/107 (23.36%) 
General disorders     
Asthenia * 1  42/106 (39.62%)  29/107 (27.10%) 
Chest pain * 1  7/106 (6.60%)  10/107 (9.35%) 
Chills * 1  30/106 (28.30%)  14/107 (13.08%) 
Extravasation * 1  1/106 (0.94%)  7/107 (6.54%) 
Fatigue * 1  36/106 (33.96%)  41/107 (38.32%) 
Influenza like illness * 1  7/106 (6.60%)  9/107 (8.41%) 
Mucosal inflammation * 1  16/106 (15.09%)  26/107 (24.30%) 
Oedema peripheral * 1  6/106 (5.66%)  13/107 (12.15%) 
Pain * 1  7/106 (6.60%)  12/107 (11.21%) 
Pyrexia * 1  35/106 (33.02%)  22/107 (20.56%) 
Immune system disorders     
Hypersensitivity * 1  6/106 (5.66%)  4/107 (3.74%) 
Infections and infestations     
Conjunctivitis * 1  8/106 (7.55%)  3/107 (2.80%) 
Cystitis * 1  8/106 (7.55%)  16/107 (14.95%) 
Gastroenteritis * 1  6/106 (5.66%)  3/107 (2.80%) 
Influenza * 1  11/106 (10.38%)  4/107 (3.74%) 
Nasopharyngitis * 1  20/106 (18.87%)  15/107 (14.02%) 
Paronychia * 1  2/106 (1.89%)  6/107 (5.61%) 
Rhinitis * 1  14/106 (13.21%)  7/107 (6.54%) 
Sinusitis * 1  4/106 (3.77%)  7/107 (6.54%) 
Upper respiratory tract infection * 1  5/106 (4.72%)  15/107 (14.02%) 
Urinary tract infection * 1  11/106 (10.38%)  13/107 (12.15%) 
Injury, poisoning and procedural complications     
Radiation skin injury * 1  1/106 (0.94%)  6/107 (5.61%) 
Investigations     
Alanine aminotransferase increased * 1  8/106 (7.55%)  11/107 (10.28%) 
Aspartate aminotransferase increased * 1  4/106 (3.77%)  10/107 (9.35%) 
Ejection fraction decreased * 1  9/106 (8.49%)  2/107 (1.87%) 
Gamma-glutamyltransferase increased * 1  9/106 (8.49%)  9/107 (8.41%) 
Weight decreased * 1  22/106 (20.75%)  22/107 (20.56%) 
Weight increased * 1  1/106 (0.94%)  6/107 (5.61%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  23/106 (21.70%)  24/107 (22.43%) 
Hypocalcaemia * 1  6/106 (5.66%)  5/107 (4.67%) 
Hypokalaemia * 1  7/106 (6.60%)  5/107 (4.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  18/106 (16.98%)  16/107 (14.95%) 
Back pain * 1  18/106 (16.98%)  27/107 (25.23%) 
Bone pain * 1  13/106 (12.26%)  7/107 (6.54%) 
Muscle spasms * 1  21/106 (19.81%)  28/107 (26.17%) 
Myalgia * 1  20/106 (18.87%)  11/107 (10.28%) 
Neck pain * 1  2/106 (1.89%)  6/107 (5.61%) 
Pain in extremity * 1  14/106 (13.21%)  29/107 (27.10%) 
Nervous system disorders     
Dizziness * 1  4/106 (3.77%)  16/107 (14.95%) 
Dysgeusia * 1  9/106 (8.49%)  8/107 (7.48%) 
Headache * 1  15/106 (14.15%)  27/107 (25.23%) 
Neuropathy peripheral * 1  11/106 (10.38%)  23/107 (21.50%) 
Paraesthesia * 1  20/106 (18.87%)  9/107 (8.41%) 
Peripheral sensory neuropathy * 1  9/106 (8.49%)  10/107 (9.35%) 
Polyneuropathy * 1  5/106 (4.72%)  8/107 (7.48%) 
Psychiatric disorders     
Anxiety * 1  2/106 (1.89%)  10/107 (9.35%) 
Depression * 1  10/106 (9.43%)  8/107 (7.48%) 
Insomnia * 1  10/106 (9.43%)  19/107 (17.76%) 
Renal and urinary disorders     
Dysuria * 1  3/106 (2.83%)  7/107 (6.54%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  18/106 (16.98%)  24/107 (22.43%) 
Dyspnoea * 1  12/106 (11.32%)  26/107 (24.30%) 
Epistaxis * 1  14/106 (13.21%)  21/107 (19.63%) 
Nasal dryness * 1  2/106 (1.89%)  6/107 (5.61%) 
Nasal inflammation * 1  3/106 (2.83%)  8/107 (7.48%) 
Oropharyngeal pain * 1  13/106 (12.26%)  5/107 (4.67%) 
Rhinorrhoea * 1  5/106 (4.72%)  7/107 (6.54%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  27/106 (25.47%)  28/107 (26.17%) 
Dry skin * 1  7/106 (6.60%)  12/107 (11.21%) 
Erythema * 1  9/106 (8.49%)  3/107 (2.80%) 
Nail disorder * 1  6/106 (5.66%)  6/107 (5.61%) 
Onychoclasis * 1  2/106 (1.89%)  8/107 (7.48%) 
Pruritus * 1  12/106 (11.32%)  9/107 (8.41%) 
Rash * 1  25/106 (23.58%)  12/107 (11.21%) 
Vascular disorders     
Hot flush * 1  7/106 (6.60%)  5/107 (4.67%) 
Hypertension * 1  8/106 (7.55%)  31/107 (28.97%) 
Hypotension * 1  6/106 (5.66%)  3/107 (2.80%) 
Phlebitis * 1  3/106 (2.83%)  8/107 (7.48%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
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
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01565083     History of Changes
Other Study ID Numbers: MO27782
2011-003308-18 ( EudraCT Number )
First Submitted: March 26, 2012
First Posted: March 28, 2012
Results First Submitted: September 30, 2016
Results First Posted: November 22, 2016
Last Update Posted: November 22, 2016