Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

NCT00002460 | Unknown Phase 3

• 3 other identifiers: CRC-PHASE-III-88002CDR0000075539UKM-CRC-BR-UNDER 50
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 34

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.

Conditions

Breast Cancer

Keywords

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

Interventions

goserelin acetate DRUG

tamoxifen citrate DRUG

ablative endocrine surgery PROCEDURE

oophorectomy PROCEDURE

Eligibility Criteria

• Age: Up to 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (34)

Hopital De Braine-L'Alleud-Waterloo

Braine-l'Alleud, 1420, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

U.Z. Sint-Rafael

Leuven, B-3000, Belgium

Location

Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Castle Hill Hospital

Cottingham, England, HU16 5JQ, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Mayday University Hospital

Croydon, England, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Whittington Hospital

London, England, N19 5NF, United Kingdom

Location

Guy's, King's and St. Thomas' Hospitals Trust

London, England, SE1 7EH, United Kingdom

Location

Cancer Research Campaign Clinical Trials Unit-London

London, England, SE5 9NU, United Kingdom

Location

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, W1N 8AA, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, L63 4JY, United Kingdom

Location

South Tees Acute Hospitals NHS Trust

Middlesbrough, Cleveland, England, TS4 3BW, United Kingdom

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, England, P03 6AD, United Kingdom

Location

Salisbury General Infirmary

Salisbury, England, SP2 7SX, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

North Tees General Hospital

Stockton-on-Tees, England, TS19 8PE, United Kingdom

Location

North Staffs Royal Infirmary

Stoke-on-Trent, England, ST4 7LN, United Kingdom

Location

Radiotherapy Department

Stratford-on-Avon, Warwickshire, England, CV37 6NX, United Kingdom

Location

Sunderland Royal Infirmary

Sunderland, England, SR2 7JE, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Hampshire County Hospital

Winchester, England, SO22 5DG, United Kingdom

Location

Belfast City Hospital Trust

Belfast, Northern Ireland, BT8 8JR, United Kingdom

Location

Belfast City Hospital Trust

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Mid-Ulster Hospital

Londonderry, Northern Ireland, BT45 5EX, United Kingdom

Location

Ards General Hospital

Newtownards, Northern Ireland, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Velindre Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin; Tamoxifen; Ovariectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures

Study Officials

• Michael Baum, MD, ChM, FRCS

  University College London Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 9, 2004
• Study Start: September 1, 1987
• Last Updated: August 7, 2013

Record last verified: 2006-12

Locations

BE (3); GB (31)