Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002460
• Other study ID #: CRC-PHASE-III-88002
• Secondary ID: CDR0000075539UKM
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: August 6, 2013
• Start date: September 1987

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 49 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• goserelin acetate

• tamoxifen citrate

Procedure:
• ablative endocrine surgery

• oophorectomy

Locations

Country	Name	City	State
Belgium	Hopital De Braine-L'Alleud-Waterloo	Braine-L'Alleud
Belgium	Institut Jules Bordet	Brussels
Belgium	U.Z. Sint-Rafael	Leuven
United Kingdom	Belfast City Hospital Trust	Belfast	Northern Ireland
United Kingdom	Belfast City Hospital Trust	Belfast	Northern Ireland
United Kingdom	Royal Sussex County Hospital	Brighton	England
United Kingdom	Velindre Hospital	Cardiff	Wales
United Kingdom	Castle Hill Hospital	Cottingham	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Mayday University Hospital	Croydon	England
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England
United Kingdom	Cookridge Hospital	Leeds	England
United Kingdom	Cancer Research Campaign Clinical Trials Unit-London	London	England
United Kingdom	Guy's, King's and St. Thomas' Hospitals Trust	London	England
United Kingdom	Middlesex Hospital- Meyerstein Institute	London	England
United Kingdom	Royal Marsden NHS Trust	London	England
United Kingdom	Whittington Hospital	London	England
United Kingdom	Mid-Ulster Hospital	Londonderry	Northern Ireland
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	Ards General Hospital	Newtownards	Northern Ireland
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

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Countries where clinical trial is conducted

Belgium,  United Kingdom,