NCT00493636

1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy

A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to Placebo When Administered in Combination With Chemotherapy for Patients With Locally Advanced or MBC That Has Progressed During or After Bevacizumab Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Accelerated Community Oncology Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to compare progression-free survival in patients treated with sorafenib and gemcitabine/capecitabine versus patients treated with placebo and gemcitabine/capecitabine for locally advanced or metastatic breast cancer that has progressed during or following treatment with a bevacizumab-containing regimen.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
DRUG	Sorafenib	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
DRUG	Placebo	Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
DRUG	Capecitabine	Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-09-01
• Completion: 2012-11-01
• First posted: 2007-06-28
• Last updated: 2014-05-20
• Results posted: 2014-05-16

Locations

44 sites across 1 country: United States