Trial Information

A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients

OBJECTIVES:

- Compare the impact of adjuvant epirubicin with or without docetaxel and concurrent or
sequential tamoxifen on time to relapse and overall survival in postmenopausal women
with node-positive breast cancer.

- Compare the toxic effects of these regimens in this patient population.

- Compare the quality of life in terms of shift in long term toxicity and differences in
recuperation in women treated with these regimens.

- Compare the incidence of thromboembolic events during the first 9 months of study and
the influence of such events on compliance in women treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to one of two adjuvant chemotherapy treatment
arms within 30 days after surgery.

- Arm I: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues
every 28 days for 6 courses.

- Arm II: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues
every 28 days for 3 courses. Patients then receive docetaxel IV over 1 hour on day 1.
Treatment continues every 21 days for 3 courses.

Patients may be further randomized to one of two tamoxifen arms. Patients not randomized to
the tamoxifen arms receive oral tamoxifen daily for 5 years concurrently with adjuvant
chemotherapy.

- Arm I: Patients receive tamoxifen as above concurrently with adjuvant chemotherapy.

- Arm II: Patients receive sequential tamoxifen as above after completion of adjuvant
chemotherapy.

Quality of life is assessed at baseline, 9 months, 2 years, and then at 5 years.

Patients are followed at 9 months, 1 year, every 4 months for 1 year, every 6 months for 2
years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.