A Multicenter, Single Arm, Open-Label PhIV Study to Investigate the Effect of First-Line Herceptin (Trastuzumab) in Combination With a Taxane in Patients With Metastatic Breast Cancer Who Relapsed After Receiving (Neo)Adjuvant Herceptin for HER2-Positive Early Breast Cancer
Inclusion Criteria:
- Female patients, >/= 18 years of age
- Locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular
lymph nodes is regarded as metastatic disease)
- HER2-positive primary disease
- Patients must have received Herceptin in the adjuvant and/or neoadjuvant setting
- Relapsed breast cancer >/= 6 months after discontinuing last drugs of Herceptin
and/or chemotherapy in the adjuvant and/or neoadjuvant setting for HER2-positive
breast cancer
- Measurable disease according to RECIST 1.0
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Maximum cumulative dose of doxorubicin = 360 mg/m2 or of epirubicin = 720 mg/m2
or no prior anthracyclines
- At least 3 weeks after prior surgery or radiotherapy
Exclusion Criteria:
- Pregnant or breastfeeding women
- Previous chemotherapy for metastatic breast cancer (prior endocrine therapy till
progressive disease is allowed)
- Pleural effusions, ascites or bone lesions as only manifestation of disease
- Brain metastases
- Invasive malignancy other than metastatic breast cancer
- Inadequate bone marrow, hepatic or renal function
- Prior treatment with anti-HER therapies other than (neo)adjuvant Herceptin