Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

273

Participants

Timeline

Start Date

September 30, 2003

Primary Completion Date

August 31, 2007

Study Completion Date

September 30, 2010

Conditions
Breast Cancer
Interventions
DRUG

5-Fluorouracil

"FEC Chemotherapy: 500 mg/m\^2 IV on day 1 of 21 day cycle.~FAC Chemotherapy: 500 mg/m\^2 IV on day 1 and day 4 of 21 day cycle."

DRUG

Cyclophosphamide

"FAC and FEC Chemotherapy:~500 mg/m\^2 IV on day 1 of 21 day cycle."

DRUG

Doxorubicin

FAC Chemotherapy: 50 mg/m\^2 IV on day 1 over 72 hour continuous infusion or IV bolus.

DRUG

Paclitaxel

80 mg/m\^2 by vein (IVPB) over 1 hour every week for 12 weeks

DRUG

Epirubicin

FEC: 100 mg/m\^2 IV on day 1 of 21 day cycle.

Trial Locations (4)

77030

UT MD Anderson Cancer Center, Houston

Unknown

Centro Medico Nacional de Occidente, Guadalajara

Instituto Nacional de Enfermedades Neoplasicas, Lima

Grupo Español de Investigacion en Cancer de Mama, Madrid

Sponsors
All Listed Sponsors
collaborator

Breast Cancer Research Foundation

OTHER

lead

M.D. Anderson Cancer Center

OTHER