NCT00005908 - Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2000

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions

Breast CancerBreast Neoplasm

Interventions

DRUG

Docetaxel - Dose A

Dose A-Cohort 1 Docetaxel 75 mg/m\^2 intravenous day 1

DRUG

Anastrozole

1 mg orally daily for five years

DRUG

cyclophosphamide

600 mg/m\^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1

DRUG

Docetaxel - Dose B

Dose B - Cohort 2 Docetaxel 60 mg/m\^2 intravenous day 1

DRUG

Doxorubicin hydrochloride

60 mg/m\^2 will be administered as a slow intravenous push on day 1

DRUG

Tamoxifen Citrate

20 mg/day orally for five years

DRUG

Capecitabine - Dose B

Dose B - Cohort 2 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15

DRUG

Capecitabine - Dose A

capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles

Trial Locations (1)

National Naval Medical Center, Bethesda

All Listed Sponsors

lead

National Cancer Institute (NCI)

NIH