NCT00002582

Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	CMF regimen
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	fluorouracil
DRUG	goserelin acetate
DRUG	leuprolide acetate
DRUG	methotrexate
DRUG	tamoxifen citrate
PROCEDURE	oophorectomy
RADIATION	radiation therapy

Timeline

• Start date: 1993-06-01
• Completion: 2007-04-01
• First posted: 2003-07-08
• Last updated: 2013-08-02

Locations

2 sites across 1 country: United Kingdom