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NCT00002460

Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1987-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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stage I breast cancer stage II breast cancer stage IIIA breast cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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goserelin acetate

Intervention Type DRUG

tamoxifen citrate

Intervention Type DRUG

ablative endocrine surgery

Intervention Type PROCEDURE

oophorectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Principal Investigators

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Michael Baum, MD, ChM, FRCS

Role: STUDY_CHAIR

University College London Hospitals

Locations

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Hopital De Braine-L'Alleud-Waterloo

Braine-l'Alleud, , Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

U.Z. Sint-Rafael

Leuven, , Belgium

Site Status

Royal Sussex County Hospital

Brighton, England, United Kingdom

Site Status

Castle Hill Hospital

Cottingham, England, United Kingdom

Site Status

Walsgrave Hospital

Coventry, England, United Kingdom

Site Status

Mayday University Hospital

Croydon, England, United Kingdom

Site Status

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

Site Status