Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without combination chemotherapy in treating postmenopausal women with stage I or stage II breast cancer that can be surgically removed.
|Breast Cancer||Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate Drug: tamoxifen citrate Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||PROTOCOL FOR THE SCOTTISH POSTMENOPAUSAL CHEMO-ENDOCRINE TRIAL|
|Study Start Date:||June 1993|
OBJECTIVES: I. Compare the potential benefits of adjuvant tamoxifen with or without cyclophosphamide, methotrexate, and fluorouracil (CMF) in postmenopausal women with stage I-IIIA, unilateral, invasive breast cancer.
OUTLINE: This is a randomized study, multicenter study. Patients are stratified according to nodal status (positive vs negative or unknown) and hospital region. Patients undergo surgical resection with or without local radiotherapy, as appropriate. Radiotherapy begins within 8 weeks of surgery for patients randomized to arm I and within 4 weeks after completion of chemotherapy for patients randomized to arm II. Patients are randomized to 1 of 2 treatment arms, preferably within 2 weeks after surgery. Arm I: Beginning within 4 weeks after surgery, patients receive oral tamoxifen daily. Treatment continues for 5 years. Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1 (CMF). Chemotherapy continues every 3 weeks for 6 courses. Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002581
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 9NQ|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|University of Glasgow|
|Glasgow, Scotland, United Kingdom, G61 1BD|
|Inverness, Scotland, United Kingdom, 1V2 3UJ|
|Royal Alexandra Hospital|
|Paisley, Scotland, United Kingdom|
|Ayr, United Kingdom, KA6 6DX|
|Falkirk Royal Infirmary|
|Falkirk, United Kingdom, FK1 5RE|
|Study Chair:||W.D. George, MD, MS, FRCS||University of Glasgow|