Biologic Correlative Taxotere/AC

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 30, 2002

Primary Completion Date

April 30, 2006

Study Completion Date

January 31, 2012

Conditions
Breast Cancer
Interventions
DRUG

Taxotere

Docetaxel (Taxotere) 100 mg/m2 is to be administered on day 1. A core biopsy is to be performed one day after chemotherapy (day 2) and on days 8, 15 and 22. On day 22, after repeat core biopsy, a second cycle of docetaxel (Taxotere) chemotherapy (100 mg/m2) will be given. Docetaxel (Taxotere) will be given three-weekly for a total of four cycles. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.

DRUG

Adriamycin/cytoxan

Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.

Trial Locations (1)

77030

Baylor Breast Center, Houston

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

lead

Baylor Breast Care Center

OTHER

NCT00206466 - Biologic Correlative Taxotere/AC | Biotech Hunter | Biotech Hunter