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

NCT00262067 ↗

Phase 3 Unknown 1237 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2005-12
Primary completion: 2008-07
Completion: 2013-12

Publications

Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Docetaxel	Small molecule	100 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Background	Epirubicin	Small molecule	90 mg/m2	Intravenous
Background	Epirubicin	Small molecule	100 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	260 mg/m2	Intravenous
Background	fluorouracil	Small molecule	500 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications