NCT00590785 - Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394) | Biotech Hunter

Enrollment

60

Participants

Timeline

Start Date

August 13, 1996

Primary Completion Date

June 10, 1997

Study Completion Date

January 13, 2015

Conditions

High RiskBreast CancerPositive NodesCyclophosphamideDoxorubicin

Interventions

DRUG

Doxorubicin

High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.

DRUG

Cyclophosphamide

High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.

DRUG

G-CSF

High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.

DRUG

tamoxifen

High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.

DRUG

ciprofloxacin

High-dose sequential doxorubicin x 4 given with G-CSF on Days 3 - 12+ and followed by high-dose cyclophosphamide x 3 (A+C) given with G-CSF and ciprofloxacin on Days 3-12, followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamxifen 20 mg daily for 5 years.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York