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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000075539 | Registry Identifier | PDQ (Physician Data Query) | |
| UKM-CRC-BR-UNDER 50 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| goserelin acetate | Drug | |||
| tamoxifen citrate | Drug | |||
| ablative endocrine surgery | Procedure | |||
| oophorectomy | Procedure |
DISEASE CHARACTERISTICS: Operable, clinical Stage I/II breast cancer (T1-3, N0-1, M0) No evidence of distant metastases on x-ray of chest, spine, and pelvis Bone scan evidence alone of secondary mass allowed unless considered unequivocal evidence of metastasis No primary carcinoma fixed to underlying muscle or chest wall No deeply fixed axillary nodes No ulceration, skin infiltration, or peau d'orange involving more than 1/3 of breast No bilateral tumors Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Under 50 Sex: Women only Menopausal status: Any status Performance status: Not specified Life expectancy: No limits on life expectancy due to intercurrent illness Hematopoietic: WBC at least 3,000 Platelets at least 90,000 Hemoglobin at least 10 g/dL Hepatic: Normal liver function required Renal: Normal kidney function required Other: Fit for surgery No prior treatment for other malignancies except: Nonmelanomatous skin cancer Cone-biopsied in situ carcinoma of the cervix English-speaking patients eligible for quality-of-life assessments
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Chemotherapy for high-risk patients allowed at the discretion of the clinician Endocrine therapy: At least 6 weeks since prior hormonal therapy No concomitant hormonal therapy including oral contraceptives (patients must discontinue the pill for 2 years) Radiotherapy: Not specified Surgery: Not specified
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| Name | Affiliation | Role |
|---|---|---|
| Michael Baum, MD, ChM, FRCS | University College London Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital De Braine-L'Alleud-Waterloo | Braine-l'Alleud | 1420 | Belgium | |||
| Institut Jules Bordet |
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| Brussels |
| 1000 |
| Belgium |
| U.Z. Sint-Rafael | Leuven | B-3000 | Belgium |
| Royal Sussex County Hospital | Brighton | England | BN2 5BE | United Kingdom |
| Castle Hill Hospital | Cottingham | England | HU16 5JQ | United Kingdom |
| Walsgrave Hospital | Coventry | England | CV2 2DX | United Kingdom |
| Mayday University Hospital | Croydon | England | United Kingdom |
| Huddersfield Royal Infirmary | Huddersfield, West Yorks | England | HD3 3EA | United Kingdom |
| Cookridge Hospital | Leeds | England | LS16 6QB | United Kingdom |
| Whittington Hospital | London | England | N19 5NF | United Kingdom |
| Guy's, King's and St. Thomas' Hospitals Trust | London | England | SE1 7EH | United Kingdom |
| Cancer Research Campaign Clinical Trials Unit-London | London | England | SE5 9NU | United Kingdom |
| Royal Marsden NHS Trust | London | England | SW3 6JJ | United Kingdom |
| Middlesex Hospital- Meyerstein Institute | London | England | W1N 8AA | United Kingdom |
| Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | L63 4JY | United Kingdom |
| South Tees Acute Hospitals NHS Trust | Middlesbrough, Cleveland | England | TS4 3BW | United Kingdom |
| Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| Derriford Hospital | Plymouth | England | PL6 8DH | United Kingdom |
| Portsmouth Hospitals NHS Trust | Portsmouth | England | P03 6AD | United Kingdom |
| Salisbury General Infirmary | Salisbury | England | SP2 7SX | United Kingdom |
| Royal South Hants Hospital | Southampton | England | SO14 0YG | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| North Tees General Hospital | Stockton-on-Tees | England | TS19 8PE | United Kingdom |
| North Staffs Royal Infirmary | Stoke-on-Trent | England | ST4 7LN | United Kingdom |
| Radiotherapy Department | Stratford-on-Avon, Warwickshire | England | CV37 6NX | United Kingdom |
| Sunderland Royal Infirmary | Sunderland | England | SR2 7JE | United Kingdom |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| Royal Hampshire County Hospital | Winchester | England | SO22 5DG | United Kingdom |
| Belfast City Hospital Trust | Belfast | Northern Ireland | BT8 8JR | United Kingdom |
| Belfast City Hospital Trust | Belfast | Northern Ireland | BT9 7AB | United Kingdom |
| Mid-Ulster Hospital | Londonderry | Northern Ireland | BT45 5EX | United Kingdom |
| Ards General Hospital | Newtownards | Northern Ireland | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | Scotland | DD1 9SY | United Kingdom |
| Velindre Hospital | Cardiff | Wales | CF4 7XL | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D013629 | Tamoxifen |
| D010052 | Ovariectomy |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002369 | Castration |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013519 | Urogenital Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
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