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A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Genentech.   Recruitment status was  Active, not recruiting

First Received on January 23, 2006.   Last Updated on September 22, 2008   History of Changes
Sponsor: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00281697
  Purpose

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 MBC.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: bevacizumab
Drug: chemotherapy
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS in individual primary chemotherapy cohorts [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • 1-year survival; overall survival [ Time Frame: 1-year; until death or loss to follow up ] [ Designated as safety issue: No ]
  • Objective response and duration of objective response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Serious and selected adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: February 2006
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab
Intravenous repeating dose
Drug: chemotherapy
Repeating dose
Placebo Comparator: 2 Drug: chemotherapy
Repeating dose
Drug: placebo
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 [U.S. 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
  • 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 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 ER and PR status
  • Radiation therapy other than for palliation or brain metastasis, biologic therapy, or chemotherapy for MBC within 21 days prior to Day 0
  • Prior therapy with bevacizumab or other VEGF pathway-targeted therapy
  • Untreated brain metastasis
  • Inadequately controlled hypertension
  • Unstable angina
  • New York Heart Association Grade II or greater 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281697

  Show 312 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Jai Balkissoon, M.D. Genentech
  More Information

No publications provided

Responsible Party: Jai Balkissoon, M.D., Study Director, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00281697     History of Changes
Other Study ID Numbers: AVF3693g
Study First Received: January 23, 2006
Last Updated: September 22, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Ribbon 2
Avastin
MBC
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012