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Monoclonal Antibodies

Bevacizumab + chemotherapy for Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the data cut-off date of 31 jul 2008 (up to 2 years, 7 months)
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the data cut-off date of 31 jul 2008 (up to 2 years, 7 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the data cut-off date of 31 jul 2008 (up to 2 years, 7 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary outcome measures
1-year Survival
Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bevacizumab + chemotherapyExperimental Treatment2 Interventions
Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle plus one of several standard chemotherapies (taxanes, anthracycline-based regimens, or capecitabine) for metastatic breast cancer.
Group II: Placebo + chemotherapyPlacebo Group2 Interventions
Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + 1 of several standard chemotherapies (taxanes, anthracycline-based regimens, or capecitabine) for metastatic breast cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,540 Previous Clinical Trials
566,692 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Leonardo Faoro, MDStudy DirectorGenentech, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments
Wedam, Suparna B., Julia A. Beaver, Laleh Amiri-Kordestani, Erik Bloomquist, Shenghui Tang, Kirsten B. Goldberg, Rajeshwari Sridhara, et al.. 2018. “US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.74.6917.
clinicaltrials.govStudy
A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)
2005. "A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00262067.
All > Metastatic Breast Cancer > Breast
~64 spots leftby Apr 2025
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