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

A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: goserelin acetate; Drug: raloxifene

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Manchester, England, United Kingdom, M20 4BX
      • Christie Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom

Study record dates

Study Major Dates

• Study Start: March 1, 2000
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: March 8, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): June 26, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Goserelin; Raloxifene Hydrochloride
• Other Study ID Numbers: NCRI-IBIS-RAZOR; CDR0000069233 (Registry Identifier: PDQ (Physician Data Query)); EU-20053; UKCCCR-IBIS-RAZOR; ISRCTN17775670