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A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer

Phase 3
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.

Outcome Time Frame:

Baseline to data cut-off (up to 3 years, 2 months)

Safety Issue:


Principal Investigator

Leo Faoro, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

September 2012

Related Keywords:

  • Metastatic Breast Cancer
  • Ribbon 2
  • Avastin
  • MBC
  • Breast cancer
  • Breast Neoplasms