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

• Overall response rate (Complete and partial response), tumour assessments according RECIST criteria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
• Duration of response: Time from objective response to disease progression [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
• Safety: Incidence of adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
• Determination of biomarkers indicative for response (serum and tumour tissue analyses) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastutumab) in combination with a taxane as first line therapy in patients with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Patients 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.

• Drug: trastuzumab [Herceptin]
  4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
• Drug: paclitaxel
  90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks)
• Drug: docetaxel
  100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks)

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