A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment

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

This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Participants will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.

Inclusion Criteria:

• Female participants , >/= 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
• Participants 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