NCT00262067

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,237 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes a blinded treatment phase, an optional open-label post-progression phase, and a survival follow-up phase. During the blinded treatment phase, patients receive chemotherapy and study drug (bevacizumab or placebo) every 3 weeks until disease progression, treatment-limiting toxicity, or death due to any cause. The optional open-label post-progression phase consists of chemotherapy treatment (per investigator discretion) and optional treatment with open-label bevacizumab. Patients who complete the study or who discontinue from treatment (regardless of participation in the optional open-label post-progression phase) will be followed for survival and subsequent anti-cancer therapies every 4 months until death, withdrawal of consent, loss to follow-up, or study termination. Patients who discontinue from treatment during the blinded treatment phase for reasons other than disease progression will have tumor assessments every 9 weeks until documented disease progression or death.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Patients received bevacizumab until disease progression, treatment limiting toxicity, or death due to any cause up to a maximum treatment duration of 48 months. The dose of bevacizumab was based on the patient's weight at either screening or baseline and remained the same throughout the blinded treatment phase of the study. The initial dose was delivered over 90±10 minutes. If there were no infusion related adverse events (fever and/or chills), the second infusion was delivered over 60±10 minutes. If the 60 minute infusion was well tolerated, all subsequent infusions were delivered over 30±10 minutes.
DRUG	Placebo	Placebo consisted of the vehicle for bevacizumab without the antibody.
DRUG	Chemotherapy	The chemotherapy was selected by the investigator prior to randomization. Chemotherapy treatment continued until disease progression, unacceptable toxicity, investigator/patient decision, or death, whichever occurred first, except for the anthracycline-based regimens, which had a maximum treatment duration of 8 cycles. Taxanes - 1 of the following 2 taxanes on Day 1 of every 21-day cycle 1. Docetaxel 75-100 mg/m\^2 IV 2. Paclitaxel protein-bound particles (Abraxane®) 260 mg/m\^2 IV Anthracyclines - 1 of the following 4 anthracycline-based regimens on Day 1 of every 21-day cycle 1. 5-fluorouracil 500 mg/m\^2 IV + epirubicin 90-100 mg/m\^2 IV + cyclophosphamide 500 mg/m\^2 IV 2. 5-fluorouracil 500 mg/m\^2 IV + doxorubicin 50 mg/m\^2 IV + cyclophosphamide 500 mg/m\^2 IV 3. Doxorubicin 50-60 mg/m\^2 IV + cyclophosphamide 500-600 mg/m\^2 IV 4. Epirubicin 90-100 mg/m\^2 IV + cyclophosphamide 500-600 mg/m\^2 IV Capecitabine: 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day cycle

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-07-01
• Completion: 2013-12-01
• First posted: 2005-12-06
• Last updated: 2013-12-13
• Results posted: 2013-10-25

Locations

92 sites across 22 countries: United States, Australia, Brazil, Canada, France, Greece, Guatemala, Mexico, Netherlands, Norway, Panama, Peru, Philippines, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom, Uruguay