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Brief Title: Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer
Official Title: Phase III Randomized Study of Adjuvant Therapy With Tamoxifen vs Endocrine Ablation vs Tamoxifen Plus Endocrine Ablation vs No Adjuvant Therapy in Patients Under Age 50 With Operable Breast Cancer
Study ID: NCT00002460
Brief 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. PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer.
Detailed Description: OBJECTIVES: I. Determine, in a prospective, randomized, controlled trial whether the administration of a course of adjuvant tamoxifen or ablation of ovarian function results in prolongation of time to recurrence or death in patients under 50 years of age with operable carcinoma of the breast. II. Determine how hormone manipulation affects mood and sexual functioning in these patients. OUTLINE: This is a randomized study. Patients are stratified by clinician. All patients are randomized following primary therapy, which, in addition to surgery, may include local irradiation, perioperative cyclophosphamide, or up to 6 cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF) for high-risk patients. Clinicians may elect to randomize patients to all groups or to only those groups including tamoxifen. The first group receives no further therapy. Then second group receives tamoxifen daily for at least 2 years. The third group receives ovarian ablation with goserelin via monthly injection for at least 2 years. The final group receives ovarian ablation with goserelin plus daily tamoxifen for at least 2 years. All patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually. PROJECTED ACCRUAL: 800 to 1,000 patients will be entered.
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: No
Hopital De Braine-L'Alleud-Waterloo, Braine-L'Alleud, , Belgium
Institut Jules Bordet, Brussels, , Belgium
U.Z. Sint-Rafael, Leuven, , Belgium
Royal Sussex County Hospital, Brighton, England, United Kingdom
Castle Hill Hospital, Cottingham, England, United Kingdom
Walsgrave Hospital, Coventry, England, United Kingdom
Mayday University Hospital, Croydon, England, United Kingdom
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom
Cookridge Hospital, Leeds, England, United Kingdom
Whittington Hospital, London, England, United Kingdom
Guy's, King's and St. Thomas' Hospitals Trust, London, England, United Kingdom
Cancer Research Campaign Clinical Trials Unit-London, London, England, United Kingdom
Royal Marsden NHS Trust, London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute, London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
South Tees Acute Hospitals NHS Trust, Middlesbrough, Cleveland, England, United Kingdom
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Derriford Hospital, Plymouth, England, United Kingdom
Portsmouth Hospitals NHS Trust, Portsmouth, England, United Kingdom
Salisbury General Infirmary, Salisbury, England, United Kingdom
Royal South Hants Hospital, Southampton, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
North Tees General Hospital, Stockton-On-Tees, England, United Kingdom
North Staffs Royal Infirmary, Stoke-On-Trent, England, United Kingdom
Radiotherapy Department, Stratford-on-Avon, Warwickshire, England, United Kingdom
Sunderland Royal Infirmary, Sunderland, England, United Kingdom
Royal Marsden Hospital, Sutton, England, United Kingdom
Royal Hampshire County Hospital, Winchester, England, United Kingdom
Belfast City Hospital Trust, Belfast, Northern Ireland, United Kingdom
Belfast City Hospital Trust, Belfast, Northern Ireland, United Kingdom
Mid-Ulster Hospital, Londonderry, Northern Ireland, United Kingdom
Ards General Hospital, Newtownards, Northern Ireland, United Kingdom
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Velindre Hospital, Cardiff, Wales, United Kingdom
Name: Michael Baum, MD, ChM, FRCS
Affiliation: University College London Hospitals
Role: STUDY_CHAIR