Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT00002460
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D010052', 'term': 'Ovariectomy'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002369', 'term': 'Castration'}, {'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1987-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-06-08', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen.\n\nPURPOSE: 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.', 'detailedDescription': '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.\n\nOUTLINE: 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.\n\nPROJECTED ACCRUAL: 800 to 1,000 patients will be entered.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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\n\nPATIENT 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\n\nPRIOR 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"}, 'identificationModule': {'nctId': 'NCT00002460', 'briefTitle': 'Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CRC-PHASE-III-88002'}, 'secondaryIdInfos': [{'id': 'CDR0000075539', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'UKM-CRC-BR-UNDER 50'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'goserelin acetate', 'type': 'DRUG'}, {'name': 'tamoxifen citrate', 'type': 'DRUG'}, {'name': 'ablative endocrine surgery', 'type': 'PROCEDURE'}, {'name': 'oophorectomy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1420', 'city': "Braine-l'Alleud", 'country': 'Belgium', 'facility': "Hopital De Braine-L'Alleud-Waterloo", 'geoPoint': {'lat': 50.68363, 'lon': 4.36784}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Sint-Rafael', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Walsgrave Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Croydon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mayday University Hospital', 'geoPoint': {'lat': 51.38333, 'lon': -0.1}}, {'zip': 'HD3 3EA', 'city': 'Huddersfield, West Yorks', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Huddersfield Royal Infirmary', 'geoPoint': {'lat': 53.64904, 'lon': -1.78416}}, {'zip': 'LS16 6QB', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cookridge Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'N19 5NF', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Whittington Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Guy's, King's and St. Thomas' Hospitals Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9NU', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Campaign Clinical Trials Unit-London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1N 8AA', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Middlesex Hospital- Meyerstein Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'L63 4JY', 'city': 'Merseyside', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology NHS Trust'}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough, Cleveland', 'state': 'England', 'country': 'United Kingdom', 'facility': 'South Tees Acute Hospitals NHS Trust'}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Newcastle General Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'P03 6AD', 'city': 'Portsmouth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'SP2 7SX', 'city': 'Salisbury', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Salisbury General Infirmary', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'zip': 'SO14 0YG', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal South Hants Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'TS19 8PE', 'city': 'Stockton-on-Tees', 'state': 'England', 'country': 'United Kingdom', 'facility': 'North Tees General Hospital', 'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}, {'zip': 'ST4 7LN', 'city': 'Stoke-on-Trent', 'state': 'England', 'country': 'United Kingdom', 'facility': 'North Staffs Royal Infirmary', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'CV37 6NX', 'city': 'Stratford-on-Avon, Warwickshire', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Radiotherapy Department', 'geoPoint': {'lat': 52.19166, 'lon': -1.70734}}, {'zip': 'SR2 7JE', 'city': 'Sunderland', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sunderland Royal Infirmary', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'SO22 5DG', 'city': 'Winchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Hampshire County Hospital', 'geoPoint': {'lat': 51.06513, 'lon': -1.3187}}, {'zip': 'BT8 8JR', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital Trust', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital Trust', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'BT45 5EX', 'city': 'Londonderry', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Mid-Ulster Hospital', 'geoPoint': {'lat': 54.9981, 'lon': -7.30934}}, {'city': 'Newtownards', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Ards General Hospital', 'geoPoint': {'lat': 54.59236, 'lon': -5.69092}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital and Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'CF4 7XL', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Michael Baum, MD, ChM, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'University College London Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Research UK', 'class': 'OTHER'}}}}