Conditions: Breast Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2611
Healthy volunteers: no

Brief summary:
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: capecitabine [Xeloda] intervention 2: Taxotere intervention 3: 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: 100mg/m2 iv on day 1 of each 3 week cycle

Protocol document: