Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: goserelin acetate Drug: tamoxifen citrate Procedure: ablative endocrine surgery Procedure: oophorectomy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 Start Date: | September 1987 |
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.
Eligibility| Ages Eligible for Study: | up to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| Hopital De Braine-L'Alleud-Waterloo | |
| Braine-L'Alleud, Belgium, 1420 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| U.Z. Sint-Rafael | |
| Leuven, Belgium, B-3000 | |
| United Kingdom | |
| Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BE | |
| Castle Hill Hospital | |
| Cottingham, England, United Kingdom, HU16 5JQ | |
| Walsgrave Hospital | |
| Coventry, England, United Kingdom, CV2 2DX | |
| Mayday University Hospital | |
| Croydon, England, United Kingdom | |
| Huddersfield Royal Infirmary | |
| Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
| Cookridge Hospital | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Cancer Research Campaign Clinical Trials Unit-London | |
| London, England, United Kingdom, SE5 9NU | |
| Guy's, King's and St. Thomas' Hospitals Trust | |
| London, England, United Kingdom, SE1 7EH | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, W1N 8AA | |
| Royal Marsden NHS Trust | |
| London, England, United Kingdom, SW3 6JJ | |
| Whittington Hospital | |
| London, England, United Kingdom, N19 5NF | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, L63 4JY | |
| South Tees Acute Hospitals NHS Trust | |
| Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Portsmouth Hospitals NHS Trust | |
| Portsmouth, England, United Kingdom, P03 6AD | |
| Salisbury General Infirmary | |
| Salisbury, England, United Kingdom, SP2 7SX | |
| Royal South Hants Hospital | |
| Southampton, England, United Kingdom, SO14 0YG | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| North Tees General Hospital | |
| Stockton-On-Tees, England, United Kingdom, TS19 8PE | |
| North Staffs Royal Infirmary | |
| Stoke-On-Trent, England, United Kingdom, ST4 7LN | |
| Radiotherapy Department | |
| Stratford-on-Avon, Warwickshire, England, United Kingdom, CV37 6NX | |
| Sunderland Royal Infirmary | |
| Sunderland, England, United Kingdom, SR2 7JE | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Hampshire County Hospital | |
| Winchester, England, United Kingdom, SO22 5DG | |
| Belfast City Hospital Trust | |
| Belfast, Northern Ireland, United Kingdom, BT9 7AB | |
| Belfast City Hospital Trust | |
| Belfast, Northern Ireland, United Kingdom, BT8 8JR | |
| Mid-Ulster Hospital | |
| Londonderry, Northern Ireland, United Kingdom, BT45 5EX | |
| Ards General Hospital | |
| Newtownards, Northern Ireland, United Kingdom | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Velindre Hospital | |
| Cardiff, Wales, United Kingdom, CF4 7XL | |
| Study Chair: | Michael Baum, MD, ChM, FRCS | University College London Hospitals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002460 History of Changes |
| Other Study ID Numbers: | CDR0000075539, CRC-PHASE-III-88002, UKM-CRC-BR-UNDER 50 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 4, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Tamoxifen Goserelin Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013