Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

August 6, 2013 updated by: Cancer Research UK

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Braine-L'Alleud, Belgium, 1420
        • Hopital De Braine-L'Alleud-Waterloo
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Leuven, Belgium, B-3000
        • U.Z. Sint-Rafael
  • United Kingdom
    • England
      • Brighton, England, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Cottingham, England, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Croydon, England, United Kingdom
        • Mayday University Hospital
      • Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
      • Leeds, England, United Kingdom, LS16 6QB
        • Cookridge Hospital
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust
      • London, England, United Kingdom, SE1 7EH
        • Guy's, King's and St. Thomas' Hospitals Trust
      • London, England, United Kingdom, W1N 8AA
        • Middlesex Hospital- Meyerstein Institute
      • London, England, United Kingdom, N19 5NF
        • Whittington Hospital
      • London, England, United Kingdom, SE5 9NU
        • Cancer Research Campaign Clinical Trials Unit-London
      • Merseyside, England, United Kingdom, L63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW
        • South Tees Acute Hospitals NHS Trust
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Newcastle General Hospital
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Portsmouth, England, United Kingdom, P03 6AD
        • Portsmouth Hospitals NHS Trust
      • Salisbury, England, United Kingdom, SP2 7SX
        • Salisbury General Infirmary
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Southampton, England, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Stockton-On-Tees, England, United Kingdom, TS19 8PE
        • North Tees General Hospital
      • Stoke-On-Trent, England, United Kingdom, ST4 7LN
        • North Staffs Royal Infirmary
      • Stratford-on-Avon, Warwickshire, England, United Kingdom, CV37 6NX
        • Radiotherapy Department
      • Sunderland, England, United Kingdom, SR2 7JE
        • Sunderland Royal Infirmary
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
      • Winchester, England, United Kingdom, SO22 5DG
        • Royal Hampshire County Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Belfast City Hospital Trust
      • Belfast, Northern Ireland, United Kingdom, BT8 8JR
        • Belfast City Hospital Trust
      • Londonderry, Northern Ireland, United Kingdom, BT45 5EX
        • Mid-Ulster Hospital
      • Newtownards, Northern Ireland, United Kingdom
        • Ards General Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
    • Wales
      • Cardiff, Wales, United Kingdom, CF4 7XL
        • Velindre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research UK

Investigators

  • Study Chair: Michael Baum, MD, ChM, FRCS, University College London Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1987

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 8, 2004

First Posted (Estimate)

June 9, 2004

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-PHASE-III-88002
  • CDR0000075539 (Registry Identifier: PDQ (Physician Data Query))
  • UKM-CRC-BR-UNDER 50

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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