A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

Roche

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: 5-fluorouracil

Biological: Bevacizumab

Drug: Cyclophosphamide

Drug: Epidoxorubicin

Drug: Paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00559845

2006-003291-35 (EudraCT Number)

ML19884

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment

56 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

female participants, >=18 years of age;
stage III, or inflammatory breast cancer;
estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
normal left ventricular ejection fraction (LVEF).

Exclusion criteria

previous chemotherapy/endocrine therapy;
evidence of distant metastatic disease;
other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.