None listed
Conditions
Interventions
Group 1 Type of group
Capecitabine 1250 mg/m2 po twice daily for 14 days every 3 weeks + Trastuzumab 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
Group name:Group 2 Type of group
Capecitabine 1000 mg/m2 po twice daily for 14 days every 3 weeks + Pertuzumab 840 mg iv loading, then 420 mg iv every 3 weeks + Trastuzumab 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Sex/Gender
Female
Age
18 Years to 92 Years
Inclusion criteria
Inclusion criteria: • Adult female patients >/=18 years of age • Metastatic HER2 positive breast cancer • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 • Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen) • Prior treatment with taxane-containing regimen • Left ventricular ejection fraction (LVEF) >/=50 percent • For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment
Exclusion criteria
Exclusion criteria: • Prior treatment with pertuzumab or capecitabine • Concurrent treatment with other experimental drug • Concurrent immunotherapy or anticancer hormonal therapy • Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease) • Central nervous system (CNS) metastases, which are not well controlled • History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 • History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment • History of myocardial infarction within 6 months prior to randomization • History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab • History of another cancer which could affect compliance or result interpretation • Inadequate organ function • Pregnant or breastfeeding women • life expectancy < 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Progression Free Survival (Independent Assessment) Timepoints: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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Overall Survival (OS) Timepoints:From randomization until death from any cause (up to 7.5 years) ; Outcome name: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. Measure:Overall Survival (OS) Rate Based on a 2-year Truncated Analysis Timepoints:From randomization until death from any cause (up to 2 years) ; Outcome name: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. Measure:Investigator Assessment Progression-Free Survival (PFS) Timepoints:Tumor assessments every 9 weeks from rand | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Estonia, France, Germany, Hong Kong, Hungaria, Italy, Korea South, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Slovakia, Spain, Switzerland, Thailand, United Kindgdom
Contacts
Public ContactYngrid Saldarriaga
COVANCE PERU SERVICES S.A.
Outcome results
None listed