Official Title

(E5103) A DOUBLE-BLIND PHASE III TRIAL OF DOXORUBICIN AND CYCLOPHOSPHAMIDE FOLLOWED BY PACLITAXEL WITH BEVACIZUMAB OR PLACEBO IN PATIENTS WITH LYMPH NODE POSITIVE AND HIGH RISK LYMPH NODE NEGATIVE BREAST CANCER

Purpose

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.

Detailed Description

Eligibility Criteria

Inclusion Criteria

Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, breast conservation surgery and axillary dissection or breast conservation surgery and sentinel node biopsy NOTE: breast conservation surgery includes lumpectomy, partial mastectomy, and excisional biopsy

Margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS)

patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible

Time from last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) to planned treatment start date must be > 28 days and =< 84 days

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Within =< 8 weeks prior to randomization: Absolute neutrophil count >= 1,000/mm^3

Exclusion Criteria

Patients must not have clinical evidence of inflammatory disease or fixed axillary nodes at diagnosis

Patients must not have received prior cytotoxic chemotherapy or hormonal therapy for this breast cancer

prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed NOTE: prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry

similarly, prior raloxifene use is allowed but must be discontinued at study entry

Patients must not have had any major surgical procedure within 28 days of planned treatment start date NOTE: non-operative biopsy or placement of a vascular access device is not considered a major surgery

Patients may not have had placement of a vascular access device within 24 hours of planned day 1 of treatment

Patients must not have a bleeding diathesis, hereditary or acquired bleeding disorder or coagulopathy

Keywords and/or Specific Medical Conditions

Allergy and Immunology

Obstetrics and Gynecology

Oncology (Adult)

Sponsors

National Cancer Institute (NCI)