Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer

NCT00031850 | Completed

• 5 other identifiers: NCRI-IBIS-RAZORCDR0000069233EU-20053UKCCCR-IBIS-RAZORISRCTN17775670
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of raloxifene and goserelin may be effective in preventing breast cancer. PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and goserelin in preventing breast cancer in women who have a family history of breast cancer.

Conditions

Breast Cancer

Keywords

breast cancer

Interventions

goserelin acetate DRUG

raloxifene DRUG

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * High genetic risk of developing breast cancer defined as one or more of the following: * BRCA1 or BRCA2 germ-line mutation * First-degree relative of known BRCA1 or BRCA2 mutation carrier * Family with 4 or more relatives diagnosed with female or male breast cancer or ovarian cancer before the age of 60 * Two first-degree relatives diagnosed with breast cancer before the age of 40 * p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only) * First-degree relative of a carrier in a family with classical LFS * Risk equivalent to any of the above confirmed by clinical geneticist * No evidence of breast cancer by mammography * Suspicious lesions must be confirmed as non-malignant * No prior breast cancer * No prior prophylactic mastectomy * No plan for alternative prevention measures within the next 12 months * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 30 to 45 Sex: * Female Menopausal status: * Premenopausal (follicle-stimulating hormone in premenopausal range if not menstruating) Performance status: * Not specified Life expectancy: * More than 10 years (excluding breast cancer risk) Hematopoietic: * Not specified Hepatic: * Adequate liver function Renal: * Adequate renal function Cardiovascular: * No prior deep vein thrombosis Pulmonary: * No prior pulmonary embolism Other: * Not pregnant * Fertile patients must use effective nonhormonal contraception * No psychological disorder that would preclude study compliance * No prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or cervical cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No concurrent hormonal therapy (e.g., oral contraception or hormone replacement therapy) Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * At least 30 days or 5 half-lives since prior investigational drugs * No concurrent anticoagulants

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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin; Raloxifene Hydrochloride

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; Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anthony Howell, MD

  The Christie NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2000
• Study Completion: May 1, 2007
• Last Updated: June 26, 2013

Record last verified: 2007-05

Locations

GB (1)