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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00031850
Other study ID # NCRI-IBIS-RAZOR
Secondary ID CDR0000069233EU-
Status Completed
Phase N/A
First received March 8, 2002
Last updated June 25, 2013
Start date March 2000
Est. completion date May 2007

Study information

Verified date May 2007
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 45 Years
Eligibility 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

Study Design

Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
goserelin acetate

raloxifene


Locations

Country Name City State
United Kingdom Christie Hospital NHS Trust Manchester England

Sponsors (1)

Lead Sponsor Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

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