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Monoclonal Antibodies

A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)

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

All Individual Drugs Already Approved

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to the data cut-off date of 31 jul 2008 (up to 2 years, 7 months)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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