Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00002582|
Recruitment Status : Completed
First Posted : July 8, 2003
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||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||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6000 participants|
|Official Title:||UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER, THE ADJUVANT BREAST CANCER (ABC) TRIAL|
|Study Start Date :||June 1993|
|Actual Study Completion Date :||April 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002582
|Cancer Research Campaign Trials Unit-Birmingham (CRCTU)|
|Birmingham, England, United Kingdom, B15 2TT|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||John R. Yarnold, MD, FRCR||Royal Marsden NHS Foundation Trust|
|Study Chair:||Helena Earl, MBBS, PhD, FRCP||Cancer Research Campaign Clinical Trials Centre|
|Study Chair:||Stanley B. Kaye, MD, FRCP||University of Glasgow|
|Study Chair:||Tim J. Perren, MD||Leeds Cancer Centre at St. James's University Hospital|