Conditions: Breast Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 72
Healthy volunteers: no

Brief summary:
This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Docetaxel intervention 3: Standard chemotherapy
Intervention descriptions: intervention 1: 15mg/kg iv on day 1 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: As prescribed

Protocol document: