A Multicenter Randomized Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab on Progression Free Survival, as 2nd-line Treatment in Patients With HER2-positive Metastatic Breast Cancer That Has Progressed After Previous Treatment With Trastuzumab.
Inclusion Criteria:
- Adult patients >/=18 years of age
- Metastatic HER2 positive breast cancer
- 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
- 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)
- CNS metastases, which are not well controlled
- History of exposure to anthracycline cumulative dose equivalent to 360mg/m2
doxorubicin
- 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