Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

April 30, 2001

Primary Completion Date

November 30, 2004

Study Completion Date

July 31, 2011

Conditions
Breast Cancer
Interventions
DRUG

Herceptin

Starting dose of 4 mg/kg by vein, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy for a total of 24 doses.

DRUG

Taxol

225 mg/m\^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles.

DRUG

Fluorouracil

500 mg/m\^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals.

DRUG

Cytoxan

500 mg/m\^2 on Day 1 of each cycle for 4 cycles.

DRUG

Epirubicin

75 mg/m\^2 IV on Day 1 of each cycle for 4 cycles.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

collaborator

Genentech, Inc.

INDUSTRY