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Spots Global Cancer Trial Database for Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Michael Baum, MD, ChM, FRCS

Affiliation: University College London Hospitals

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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