A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase III, multicenter, randomized, placebo-controlled, blinded trial is designed to evaluate the efficacy and safety of bevacizumab when combined with standard chemotherapy compared with chemotherapy alone in subjects with previously treated metastatic breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Signed informed consent form.

• ≥ 18 years of age.

• Histologically confirmed carcinoma of the breast with measurable or non-measurable metastatic disease that has progressed (patients with a history of brain metastasis are eligible for study participation [USA only], as long as their brain metastases have been treated and they have no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone).

• Progression of disease during or following administration of one (non-investigational) chemotherapy regimen administered in the first-line setting.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• For women of childbearing potential, use of an effective means of non-hormonal contraception.

• Life expectancy ≥ 3 months.

• Willingness and capacity to comply with study and follow-up procedures.

Exclusion Criteria:

• Prior hormonal therapy only as treatment for metastatic disease without chemotherapy. Patients must have received chemotherapy for their metastatic disease in the first-line setting. Hormone therapy alone is not allowed.

• For subjects who have received prior anthracycline-based therapy, documentation of left ventricular ejection fraction < 50% by either multiple gated acquisition (MUGA) or echocardiogram (ECHO).

• Treatment with more than one prior cytotoxic regimen for metastatic breast cancer (MBC).

• HER2-positive status (patients who have unknown HER2 status, and for whom determination of HER2 status is not possible, are eligible for this study).

• Unknown estrogen receptor (ER) and progesterone receptor (PR) status.

• Radiation therapy other than for palliation or brain metastasis, biologic therapy, or chemotherapy for MBC within 21 days prior to Day 0 (Day 1 of Cycle 1 of treatment).

• Prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) pathway-targeted therapy.

• Untreated brain metastasis.

• Inadequately controlled hypertension.

• Unstable angina.

• New York Heart Association Grade II or greater congestive heart failure (CHF).

• History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab/placebo infusion).

• History of stroke or transient ischemic attack within 6 months prior to Day 0.

• Clinically significant peripheral vascular disease.

• Evidence of bleeding diathesis or coagulopathy.

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the study.

• Minor surgical procedures, fine-needle aspirations, or core biopsies within 7 days prior to Day 0.

• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.

• Serious, non-healing wound, ulcer, or bone fracture.

• History of anaphylactic reaction to monoclonal antibody therapy not controlled with treatment premedication.

• History of other malignancies within 5 years of Day 0, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

• inadequate organ function.

• Pregnancy (positive serum pregnancy test) or lactation.

• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the subject at high risk from treatment complications.