Overview

A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
Female
Summary
This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Albumin-Bound Paclitaxel
Bevacizumab
Gemcitabine
Paclitaxel
Criteria
Inclusion Criteria:

- Female patients, ≥ 18 years of age.

- Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients
with bone metastasis only.

- HER-2 negative disease.

- Candidates for chemotherapy.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

- Previous chemotherapy for metastatic or locally advanced breast cancer.

- Previous radiotherapy for treatment of metastatic breast cancer.

- Any prior adjuvant treatment with anthracyclines completed < 6 months prior to
enrollment.

- Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or
clopidogrel (> 75mg/day).