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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00031850
First received: March 8, 2002
Last updated: June 25, 2013
Last verified: May 2007
  Purpose

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 Intervention
Breast Cancer
Drug: goserelin acetate
Drug: raloxifene

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer

Resource links provided by NLM:


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

Estimated Enrollment: 150
Study Start Date: March 2000
Study Completion Date: May 2007
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031850

Locations
United Kingdom
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 Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00031850     History of Changes
Other Study ID Numbers: NCRI-IBIS-RAZOR, CDR0000069233, EU-20053, UKCCCR-IBIS-RAZOR, ISRCTN17775670
Study First Received: March 8, 2002
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Goserelin
Raloxifene
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