A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Standard chemotherapy; Drug: bevacizumab [Avastin]; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559754

ML20382

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients, >=18 years of age;
• primary HER2-negative operable breast cancer;
• tumor >2cm in size;
• ECOG performance status 0-1.

Exclusion criteria

• previous treatment for breast cancer;
• metastatic disease;
• current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) or full-dose anticoagulants for therapeutic purposes;
• clinically significant cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Docetaxel

Drug: bevacizumab [Avastin]

Drug: Standard chemotherapy