Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002460
First received: November 1, 1999
Last updated: August 6, 2013
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: goserelin acetate
Drug: tamoxifen citrate
Procedure: ablative endocrine surgery
Procedure: oophorectomy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1987
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

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002460

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002460     History of Changes
Other Study ID Numbers: CRC-PHASE-III-88002, CDR0000075539, UKM-CRC-BR-UNDER 50
Study First Received: November 1, 1999
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on April 17, 2014