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A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Genentech
Hoffmann-La Roche
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00262067
  Purpose

This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.


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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: A Multicenter, Phase III, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer

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:
  • Objective response [ 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 ]
  • Progression-free survival in patient subsets defined by chemotherapy administered [ 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 ]
  • Clinical cardiotoxicity [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: December 2005
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: bevacizumab
Intravenous repeating dose
Drug: chemotherapy
Repeating dose
2: Placebo Comparator 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:

  • Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease
  • Signed Informed Consent Form
  • Age ≥ 18 years
  • For women of childbearing potential, use of accepted and effective method of non-hormonal contraception
  • ECOG performance status of 0 or 1
  • Ability and capacity to comply with study and follow-up procedures
  • For anthracycline cohort only: adequate left ventricular function at study entry, defined as an LVEF ≥ 50% by either MUGA scan or ECHO.
  • For subjects who have received recent radiation therapy: recovery prior to Day 0 from any significant (Grade ≥ 3) acute toxicity

Exclusion Criteria:

  • Unknown HER2 status or known HER2-positive status
  • Prior chemotherapy for locally recurrent or metastatic disease
  • Prior hormonal therapy less than 1week prior to Day 0.
  • Prior adjuvant or neoadjuvant chemotherapy within 12 months prior to Day 0
  • For anthracycline cohort only: prior anthracycline as part of neoadjuvant or adjuvant therapy for localized breast cancer
  • Investigational therapy within 28 days of Day 0
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study
  • Minor surgical procedures, such as fine needle aspirations or core biopsies, within 7 days prior to Day 0
  • Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy
  • Known brain or other CNS metastases
  • Blood pressure of > 150/100 mmHg
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater CHF
  • History of myocardial infarction within 6 months prior to Day 0
  • 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
  • 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
  • Pregnancy (positive serum pregnancy test) or lactation
  • Inadequate organ function, as evidenced by any of the following laboratory values: Absolute neutrophil count < 1500/uL; Platelet count < 100,000/uL; Total bilirubin > 1.5 mg/dL; Alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal (> 5x ULN in subjects with known liver or, for alkaline phosphatase elevations, bone involvement); Alkaline phosphatase > 2x ULN (> 7x ULN in subjects with known bone involvement); Serum creatinine > 2.0 mg/dL; PTT and/or either INR or PT > 1.5x upper limit of normal (except for subjects receiving anti-coagulation therapy); Urine protein/creatinine ratio > 1.0 at screening for U.S. subjects, or urine dipstick for proteinuria ≥ 1+ at screening followed by 24-hour urine collection demonstrating > 1 g protein/24 hr for ex-U.S. subjects
  • Uncontrolled serious medical or psychiatric illness
  • Active infection requiring IV antibiotics at Day 0
  • 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 (Subjects with a history of bilateral breast cancer will be eligible)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262067

Sponsors and Collaborators
Genentech
Hoffmann-La Roche
Investigators
Study Director: See Phan, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc. ( See Phan, M.D., Study Director )
Study ID Numbers: AVF3694g, BO20094
Study First Received: December 2, 2005
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00262067  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
MBC
Breast Cancer
Avastin
Adenocarcinoma

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Bevacizumab
Adenocarcinoma
Breast Diseases

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

ClinicalTrials.gov processed this record on January 16, 2009