Conditions: Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 52
Healthy volunteers: no

Brief summary:
This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. 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: Standard chemotherapy intervention 2: bevacizumab [Avastin] intervention 3: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: As prescribed intervention 2: 15mg/kg iv 3 weekly in cycles 1-8 intervention 3: 8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.

Protocol document: