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

Sponsor
Institute of Cancer Research, United Kingdom (Other)
Overall Status
Completed
CT.gov ID
NCT00031850
Collaborator
(none)
150
Enrollment
1
Location
86
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

OBJECTIVES:

  • Compare the feasibility of raloxifene and goserelin versus no medical intervention in women at high genetic risk for developing breast cancer.

  • Compare the incidence of adverse effects in patients treated with these regimens.

  • Compare the effect of these regimens on bone density, biochemical markers of bone turnover, and lipid profiles in these patients.

  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene daily for 6-12 months.

  • Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients undergo annual mammograms.

Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Primary Purpose:
Prevention
Official Title:
A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
Study Start Date :
Mar 1, 2000
Actual Study Completion Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Christie Hospital NHS Trust Manchester England United Kingdom M20 4BX

    Sponsors and Collaborators

    • Institute of Cancer Research, United Kingdom

    Investigators

    • Study Chair: Anthony Howell, MD, The Christie NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00031850
    Other Study ID Numbers:
    • NCRI-IBIS-RAZOR
    • CDR0000069233
    • EU-20053
    • UKCCCR-IBIS-RAZOR
    • ISRCTN17775670
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 26, 2013
    Last Verified:
    May 1, 2007
    Keywords provided by , ,
    breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Raloxifene Hydrochloride
    Goserelin

    Study Results

    No Results Posted as of Jun 26, 2013