Therapy for Locally Advanced Breast Cancer Using Doxil, Paclitaxel, and Cyclophosphamide With Avastin

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

December 31, 2014

Study Completion Date

June 30, 2015

Conditions
Invasive Breast Cancer
Interventions
DRUG

Doxil, Paclitaxel, Cyclophosphamide, Avastin

"Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience \<pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Doxil 30 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3. Patients who experience \<pCR to primary chemotherapy will receive an additional year of Avastin15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation."

Trial Locations (1)

35294 - 0104

University of Alabama at Birmingham, Birmingham

Sponsors
All Listed Sponsors
collaborator

Ortho Biotech, Inc.

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

University of Alabama at Birmingham

OTHER

NCT00635050 - Therapy for Locally Advanced Breast Cancer Using Doxil, Paclitaxel, and Cyclophosphamide With Avastin | Biotech Hunter | Biotech Hunter