A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

Phase 3 Completed 736 enrolled Hoffmann-La Roche

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Timeline

Start: 2006-03
Primary completion: 2007-10
Completion: 2013-10

Outcome

Met primary endpoint

registry Docetaxel 100 mg/m^2 Plus Placebo vs Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg; p = 0.0318; Hazard Ratio (HR) 0.79 (95% CI 0.63 to 0.98); Log Rank NCT00333775 ↗

registry Docetaxel 100 mg/m^2 Plus Placebo vs Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg; p = 0.0036; Hazard Ratio, log 0.72 (95% CI 0.57 to 0.90); Log Rank NCT00333775 ↗

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	7.5 mg/kg	Intravenous
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Docetaxel	Small molecule	100 mg/m2	Intravenous