Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 157
Healthy volunteers: no

Brief summary:
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration \[po\] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: capecitabine [Xeloda] intervention 2: Taxotere intervention 3: Herceptin (HER2-neu positive patients only) intervention 4: capecitabine [Xeloda] intervention 5: Taxotere
Intervention descriptions: intervention 1: 825mg/m2 po bid on days 1-14 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: 4mg/kg iv (loading dose) followed by 2mg/kg iv weekly intervention 4: 825mg/m2 po bid on days 1-14 of each 3 week cycle intervention 5: 75mg/m2 iv on day 1 of each 3 week cycle

Protocol document: