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Trial record 1 of 1 for:    NCT01026142
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A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)

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ClinicalTrials.gov Identifier: NCT01026142
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : October 13, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Capecitabine
Drug: Pertuzumab
Drug: Trastuzumab
Enrollment 452
Recruitment Details 452 participants were randomized to one of two treatment arms: trastuzumab and capecitabine (Arm A, 224 participants) or pertuzumab with trastuzumab and capecitabine (Arm B, 228 participants). Of participants randomized to Arm A: trastuzumab and capecitabine, 6 participants did not receive study treatment.
Pre-assignment Details  
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks. Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Period Title: Overall Study
Started 224 228
Completed 52 65
Not Completed 172 163
Reason Not Completed
Death             136             134
Withdrew consent or lost to follow-up             36             29
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab Total
Hide Arm/Group Description Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks. Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks. Total of all reporting groups
Overall Number of Baseline Participants 218 228 446
Hide Baseline Analysis Population Description
This is the safety population, which includes all participants who received any amount of study drug; 6 participants randomized to the Capecitabine + Trastuzumab arm withdrew before receiving any study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 228 participants 446 participants
55.1  (10.10) 53.0  (11.21) 54.0  (10.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 228 participants 446 participants
Female
218
 100.0%
228
 100.0%
446
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 218 participants 228 participants 446 participants
Russian Federation 8 3 11
Argentina 3 4 7
Romania 6 8 14
Hungary 13 29 42
Hong Kong 5 11 16
United Kingdom 18 17 35
Thailand 0 5 5
Spain 39 31 70
Canada 3 6 9
Czech Republic 12 10 22
Austria 2 3 5
Netherlands 0 2 2
Belgium 12 11 23
Poland 6 6 12
Brazil 7 6 13
Korea, Republic of 14 24 38
Italy 16 18 34
Mexico 1 0 1
France 19 12 31
Peru 7 8 15
Germany 23 11 34
Croatia 4 3 7
1.Primary Outcome
Title Progression Free Survival (Independent Assessment)
Hide Description Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed.
Time Frame Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 224 228
Median (95% Confidence Interval)
Unit of Measure: months
9.0
(8 to 10)
11.1
(9 to 13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: Capecitabine + Trastuzumab, B: Capecitabine + Trastuzumab + Pertuzumab
Comments

The null hypothesis for the primary endpoint is that the survival distributions of IRF-assessed PFS in the two treatment groups are the same. The alternative hypothesis is that the survival distributions of IRF-assessed PFS in the treatment and the control arms are different:

H0: IRF PFS<pertuzumab> = IRF PFS<control> vs. H1: IRF PFS<pertuzumab> ≠ IRF PFS<control>
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0731
Comments The primary endpoint, IRF-assessed PFS, is tested at a two-sided 5% significance level.
Method Log Rank
Comments Two-sided and stratified by: prior CNS disease present/absent, measurable disease at baseline, and response to trastuzumab in 1L metastatic setting.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.65 to 1.02
Estimation Comments The stratified Cox proportional hazard model will be used to estimate the HR between the two treatment arms and its 95% CI.
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the time from the date of randomization to the date of death from any cause. The results of the final OS analysis are presented here. Participants who were alive or lost to follow-up at the time of the analysis were censored at the last known alive date. Participants with no postbaseline information were censored at the time of randomization plus 1 day. Prior to the final data analysis cut-off, it was ensured that all participants who were in survival follow-up had been contacted as recently as possible within the last 3 months to confirm current survival status.
Time Frame From randomization until death from any cause (up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 224 228
Median (95% Confidence Interval)
Unit of Measure: Months
28.1
(22 to 35)
37.2
(33 to 42)
3.Secondary Outcome
Title Overall Survival (OS) Rate Based on a 2-year Truncated Analysis
Hide Description The Overall Survival (OS) 2-year truncated analysis is the Kaplan-Meier estimate of the percentage of participants who were surviving at 2 years. OS is defined as the time from the date of randomization to the date of death from any cause, with censoring of all events and follow-up beyond the end of the second year.
Time Frame From randomization until death from any cause (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 224 228
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
55.0
(48.07 to 61.85)
74.9
(69.05 to 80.68)
4.Secondary Outcome
Title Investigator Assessment Progression-Free Survival (PFS)
Hide Description Investigator Assessment Progression-Free Survival (PFS) was defined as the time from randomization to the first documented progressive disease, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death from any cause, whichever occurred first. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 224 228
Median (95% Confidence Interval)
Unit of Measure: Months
9.0
(8 to 12)
11.8
(9 to 14)
5.Secondary Outcome
Title Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment
Hide Description Time to Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease (PD), based on IRF assessment.
Time Frame Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 224 228
Median (95% Confidence Interval)
Unit of Measure: Weeks
39.0
(35 to 44)
50.6
(39 to 62)
6.Secondary Outcome
Title Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment
Hide Description Time to Treatment Failure (TTF) was defined as time between randomization and date of disease progression based on independent review, death, or withdrawal of treatment due to adverse events, withdrawn informed consent, refusal of treatment/failure to cooperate, or failure to return, whichever occurred first.
Time Frame Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 224 228
Median (95% Confidence Interval)
Unit of Measure: Weeks
39.0
(34 to 44)
50.9
(39 to 62)
7.Secondary Outcome
Title Overall Objective Response Rate (ORR)
Hide Description Overall Objective Response Rate is based upon investigator and IRF assessments. Objective Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) among those who had measurable disease at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 164 163
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response (CR) - IRF Assessment 0 1.8
Partial Response (PR) - IRF assessment 32.9 38.7
Complete Response (CR) - Investigator Assessed 1.2 6.7
Partial Response (PR) - Investigator Assessed 36.0 38.0
8.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description Clinical Benefit Rate is based upon Independent Review Facility (IRF) assessments; defined as the percentage of participants a complete response (CR), partial response (PR), or stable disease for at least 8 cycles or 6 months.
Time Frame Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 224 228
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
54.0
(47.3 to 60.7)
63.6
(57.0 to 69.8)
9.Secondary Outcome
Title Duration of Objective Response
Hide Description Duration of Objective Response was defined for the subpopulation of responders as time from first Independent Review Facility (IRF)-assessed complete response (CR) or partial response (PR) to subsequent first documented, IRF-confirmed evidence of disease progression. Only participants with an objective response were included in the analysis of duration of objective response.
Time Frame Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description:
Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
Overall Number of Participants Analyzed 54 66
Median (95% Confidence Interval)
Unit of Measure: Weeks
30.0
(21 to 42)
51.6
(42 to 57)
Time Frame Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Hide Arm/Group Description Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks. Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab [Perjeta]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
All-Cause Mortality
A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   136/218 (62.39%)      134/228 (58.77%)    
Hide Serious Adverse Events
A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/218 (24.31%)      58/228 (25.44%)    
Blood and lymphatic system disorders     
Febrile Neutropenia † 1  2/218 (0.92%)  2 1/228 (0.44%)  1
Neutropenia † 1  2/218 (0.92%)  2 1/228 (0.44%)  1
Anaemia † 1  1/218 (0.46%)  2 0/228 (0.00%)  0
Thrombocytopenia † 1  1/218 (0.46%)  1 1/228 (0.44%)  1
Pancytopenia † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Cardiac disorders     
Left Ventricular Dysfunction † 1  4/218 (1.83%)  4 13/228 (5.70%)  13
Atrial Fibrillation † 1  0/218 (0.00%)  0 2/228 (0.88%)  2
Angina Unstable † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Arteriospasm Coronary † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Cardiac Arrest † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Supraventricular Extrasystoles † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Ventricular Fibrillation † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Eye disorders     
Retinal Detachment † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Gastrointestinal disorders     
Diarrhoea † 1  6/218 (2.75%)  6 8/228 (3.51%)  8
Nausea † 1  2/218 (0.92%)  2 1/228 (0.44%)  1
Vomiting † 1  2/218 (0.92%)  2 1/228 (0.44%)  1
Abdominal Hernia † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Colitis † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Diverticulum † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Dysphagia † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Gastric Perforation † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Gastric Ulcer † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Ileus † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Subileus † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
General disorders     
General Physical Health Deterioration † 1  2/218 (0.92%)  2 2/228 (0.88%)  2
Pyrexia † 1  2/218 (0.92%)  2 2/228 (0.88%)  2
Chest Pain † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Device Related Thrombosis † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Hepatobiliary disorders     
Cholecystitis † 1  1/218 (0.46%)  1 1/228 (0.44%)  1
Hyperbilirubinaemia † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Immune system disorders     
Anaphylactic Shock † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Infections and infestations     
Sepsis † 1  2/218 (0.92%)  2 0/228 (0.00%)  0
Appendicitis † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Bacteraemia † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Catheter Site Infection † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Cellulitis † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Clostridium Difficile Colitis † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Device Related Infection † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Gastroenteritis † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Phlebitis Infective † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Pneumonia † 1  1/218 (0.46%)  1 1/228 (0.44%)  1
Pulmonary Tuberculosis † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Respiratory Tract Infection † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Urinary Tract Infection † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Injury, poisoning and procedural complications     
Femur Fracture † 1  2/218 (0.92%)  2 2/228 (0.88%)  2
Infusion Related Reaction † 1  0/218 (0.00%)  0 2/228 (0.88%)  2
Acetabulum Fracture † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Bone Fissure † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Craniocerebral Injury † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Facial Bones Fracture † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Fracture † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Hip Fracture † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Joint Dislocation † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Lumbar Vertebral Fracture † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Meniscus Injury † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Subdural Haematoma † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Synovial Rupture † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Wrist Fracture † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Subarachnoid Haemorrhage † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Investigations     
Blood Sodium Decreased † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalaemia † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Musculoskeletal and connective tissue disorders     
Back Pain † 1  1/218 (0.46%)  1 2/228 (0.88%)  2
Bone Pain † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Joint Swelling † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Osteitis † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Osteonecrosis † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Pain in Extremity † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Acute Promyelocytic Leukaemia † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Cervix Carcinoma † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Breast Cancer † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Nervous system disorders     
Syncope † 1  2/218 (0.92%)  2 1/228 (0.44%)  1
Dizziness † 1  1/218 (0.46%)  1 1/228 (0.44%)  1
Hemiparesis † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Ischaemic Stroke † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Sciatica † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Secondary Cerebellar Degeneration † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Status Epilepticus † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Psychiatric disorders     
Delirium † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Depression † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Renal and urinary disorders     
Ureteric Stenosis † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Reproductive system and breast disorders     
Endometrial Hyperplasia † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism † 1  4/218 (1.83%)  4 3/228 (1.32%)  4
Pulmonary Thrombosis † 1  0/218 (0.00%)  0 2/228 (0.88%)  2
Dyspnoea † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Skin and subcutaneous tissue disorders     
Palmar-Plantar Erythrodysaesthesia Syndrome † 1  1/218 (0.46%)  1 1/228 (0.44%)  1
Rash † 1  0/218 (0.00%)  0 1/228 (0.44%)  1
Vascular disorders     
Vena Cava Thrombosis † 1  1/218 (0.46%)  1 2/228 (0.88%)  2
Hypertension † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Thrombophlebitis Superficial † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
Venous Thrombosis † 1  1/218 (0.46%)  1 0/228 (0.00%)  0
1
Term from vocabulary, MedDRA (20.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A: Capecitabine + Trastuzumab B: Capecitabine + Trastuzumab + Pertuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   209/218 (95.87%)      216/228 (94.74%)    
Blood and lymphatic system disorders     
Neutropenia † 1  38/218 (17.43%)  89 29/228 (12.72%)  74
Anaemia † 1  17/218 (7.80%)  23 21/228 (9.21%)  28
Cardiac disorders     
Left Ventricular Dysfunction † 1  5/218 (2.29%)  5 13/228 (5.70%)  15
Eye disorders     
Lacrimation Increased † 1  13/218 (5.96%)  17 6/228 (2.63%)  8
Gastrointestinal disorders     
Diarrhoea † 1  128/218 (58.72%)  275 157/228 (68.86%)  436
Nausea † 1  97/218 (44.50%)  152 88/228 (38.60%)  129
Vomiting † 1  45/218 (20.64%)  56 37/228 (16.23%)  58
Stomatitis † 1  32/218 (14.68%)  39 41/228 (17.98%)  60
Abdominal Pain † 1  30/218 (13.76%)  36 28/228 (12.28%)  50
Abdominal Pain Upper † 1  24/218 (11.01%)  31 29/228 (12.72%)  45
Dyspepsia † 1  22/218 (10.09%)  23 24/228 (10.53%)  33
Constipation † 1  21/218 (9.63%)  27 18/228 (7.89%)  22
General disorders     
Asthenia † 1  51/218 (23.39%)  87 47/228 (20.61%)  77
Fatigue † 1  39/218 (17.89%)  59 44/228 (19.30%)  62
Mucosal Inflammation † 1  27/218 (12.39%)  36 32/228 (14.04%)  45
Pyrexia † 1  20/218 (9.17%)  24 29/228 (12.72%)  41
Oedema Peripheral † 1  13/218 (5.96%)  13 18/228 (7.89%)  19
Chest Pain † 1  12/218 (5.50%)  15 9/228 (3.95%)  11
Infections and infestations     
Viral Upper Respiratory Tract Infection † 1  12/218 (5.50%)  15 25/228 (10.96%)  37
Urinary Tract Infection † 1  17/218 (7.80%)  20 21/228 (9.21%)  28
Upper Respiratory Tract Infection † 1  9/218 (4.13%)  12 19/228 (8.33%)  46
Paronychia † 1  11/218 (5.05%)  15 15/228 (6.58%)  16
Influenza † 1  4/218 (1.83%)  5 12/228 (5.26%)  12
Investigations     
Weight Decreased † 1  13/218 (5.96%)  14 19/228 (8.33%)  20
Aspartate Aminotransferase Increased † 1  11/218 (5.05%)  15 17/228 (7.46%)  26
Alanine Aminotransferase Increased † 1  8/218 (3.67%)  11 17/228 (7.46%)  24
Metabolism and nutrition disorders     
Decreased Appetite † 1  28/218 (12.84%)  43 36/228 (15.79%)  43
Hypokalaemia † 1  13/218 (5.96%)  19 28/228 (12.28%)  40
Musculoskeletal and connective tissue disorders     
Pain in Extremity † 1  15/218 (6.88%)  24 27/228 (11.84%)  32
Arthralgia † 1  17/218 (7.80%)  19 21/228 (9.21%)  27
Back Pain † 1  18/218 (8.26%)  23 20/228 (8.77%)  23
Muscle Spasms † 1  12/218 (5.50%)  20 17/228 (7.46%)  21
Bone Pain † 1  12/218 (5.50%)  16 8/228 (3.51%)  9
Myalgia † 1  6/218 (2.75%)  8 12/228 (5.26%)  19
Musculoskeletal Chest Pain † 1  5/218 (2.29%)  7 12/228 (5.26%)  13
Nervous system disorders     
Headache † 1  39/218 (17.89%)  68 40/228 (17.54%)  52
Dizziness † 1  21/218 (9.63%)  28 24/228 (10.53%)  26
Neuropathy Peripheral † 1  14/218 (6.42%)  17 16/228 (7.02%)  17
Paraesthesia † 1  13/218 (5.96%)  15 9/228 (3.95%)  9
Psychiatric disorders     
Insomnia † 1  12/218 (5.50%)  17 23/228 (10.09%)  27
Respiratory, thoracic and mediastinal disorders     
Cough † 1  22/218 (10.09%)  27 30/228 (13.16%)  38
Dyspnoea † 1  24/218 (11.01%)  28 21/228 (9.21%)  25
Epistaxis † 1  9/218 (4.13%)  9 12/228 (5.26%)  14
Skin and subcutaneous tissue disorders     
Palmar-Plantar Erythrodysaesthesia Syndrome † 1  159/218 (72.94%)  242 129/228 (56.58%)  179
Rash † 1  11/218 (5.05%)  12 35/228 (15.35%)  45
Pruritus † 1  7/218 (3.21%)  7 21/228 (9.21%)  29
Dry Skin † 1  9/218 (4.13%)  10 16/228 (7.02%)  17
Nail Disorder † 1  8/218 (3.67%)  8 14/228 (6.14%)  15
Alopecia † 1  11/218 (5.05%)  12 6/228 (2.63%)  6
Vascular disorders     
Hypertension † 1  14/218 (6.42%)  18 19/228 (8.33%)  19
1
Term from vocabulary, MedDRA (20.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
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: NCT01026142    
Other Study ID Numbers: MO22324
2008-006801-17 ( EudraCT Number )
First Submitted: November 27, 2009
First Posted: December 4, 2009
Results First Submitted: August 17, 2016
Results First Posted: October 13, 2016
Last Update Posted: August 14, 2018