Phase II Bevacizumab + Tax In Advanced Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

November 30, 2001

Primary Completion Date

December 31, 2005

Study Completion Date

August 31, 2010

Conditions
Breast Cancer
Interventions
BIOLOGICAL

bevacizumab

Patients receive bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.

DRUG

cyclophosphamide

Approximately 4 weeks after the completion of radiotherapy, patients receive cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

DRUG

docetaxel

Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.

DRUG

doxorubicin hydrochloride

Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

PROCEDURE

adjuvant therapy

"After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.~Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."

PROCEDURE

conventional surgery

After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery.

PROCEDURE

neoadjuvant therapy

"Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.~Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."

RADIATION

radiation therapy

Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.

Trial Locations (5)

44121

UH-Green Road, South Euclid

44122

UH-Chagrin Highlands, Orange

44130

UH-Southwest, Middleburg Heights

44145

UH-Westlake, Westlake

44106-5055

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00027885 - Phase II Bevacizumab + Tax In Advanced Breast Cancer | Biotech Hunter | Biotech Hunter