Trial Information

UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER, THE ADJUVANT BREAST CANCER (ABC) TRIAL

OBJECTIVES:

- Estimate overall and relapse-free survival of women with early-stage breast cancer
receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian
suppression.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
institution and choice of randomization option.

Postmenopausal women are randomized to the first or second groups.

Randomization for pre- and perimenopausal women is based on the clinician's judgement of
appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be
randomized as follows: among all four groups; for chemotherapy alone (first versus second
group); for ovarian suppression alone (first versus third group); for ovarian suppression
with nonrandomized assignment to chemotherapy (second versus forth group); for chemotherapy
with nonrandomized assignment to ovarian suppression (second versus fourth group).

- First group: Patients receive tamoxifen by mouth every day for 5 years.

- Second group: Patients receive tamoxifen plus cyclophosphamide, methotrexate,
fluorouracil (CMF) or doxorubicin/cyclophosphamide (AC). CMF is given every month for 6
courses; AC is given every 3 weeks for 4 courses.

- Third group: Patients receive tamoxifen plus ovarian suppression by oophorectomy,
radiation castration, or leuprolide or goserelin.

- Fourth group: Patients receive tamoxifen plus ovarian suppression plus chemotherapy
with CMF or AC.

Patients are followed for overall and relapse-free survival.

PROJECTED ACCRUAL: Approximately 6,000 women (4,000 premenopausal, 2,000 postmenopausal)
will be accrued for this study.