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Sponsor: Hoffmann-La Roche
Conditions: Breast Cancer
Interventions: Capecitabine, Capecitabine, Pertuzumab, Trastuzumab
Countries: Argentina, Austria, Belgium, Brazil, Canada, Croatia, Czechia, Estonia
This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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: * 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
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- La Plata, Argentina
- Quilmes, Argentina
- Rosario, Argentina
- Santa Fe, Argentina
- Krems, Austria
- Rankweil, Austria
- Salzburg, Austria
- Vienna, Austria
- Bonheiden, Belgium
- Brasschaat, Belgium
- Brussels, Belgium
- Charleroi, Belgium
- Haine-Saint-Paul, Belgium
- Hasselt, Belgium
- Kortrijk, Belgium
- Liège, Belgium
- Liège, Belgium
- Namur, Belgium
- Sint-Niklaas, Belgium
- Cachoeiro de Itapemirim, Espírito Santo, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo- SP, São Paulo, Brazil
- Oshawa, Ontario, Canada
- Toronto, Ontario, Canada
- Toronto, Ontario, Canada
- Zagreb, Croatia
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