Official Title: “A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive 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 may be an effective way to prevent breast cancer in premenopausal women.

PURPOSE: Phase II trial to study the effectiveness of raloxifene in preventing invasive breast cancer in premenopausal women.

Study Type: Interventional

Study Design: Prevention

OBJECTIVES: - Determine the safety and tolerability of raloxifene in premenopausal women at high risk of developing invasive breast cancer. - Determine the effect of raloxifene on blood steroid hormone levels (luteinizing hormone, estradiol, progesterone) and carotenoid levels during the menstrual cycle in these participants. - Determine the effect of raloxifene on the endometrium and ovaries in these participants. - Determine the effect of raloxifene on biochemical markers of bone metabolism, lipid profiles, and fibrinogen in these participants. - Determine the effect of raloxifene on health-related quality of life of these participants. - Determine the effect of raloxifene on bone mineral density in the spine and hip of these participants.

OUTLINE: This is an open-label study.

Participants are medically evaluated, followed by an observation period of 1 to 2 menstrual cycles. After the observation period, participants receive oral raloxifene once daily for 2 years.

Quality of life is assessed 1 week prior to study drug administration and at 6, 12, 24 and 36 months after study drug administration.

Participants are followed for 1 year.

PROJECTED ACCRUAL: A total of 41 participants will be accrued for this study within 3 years.

Intervention(s) in this Clinical Trial

• Drug: raloxifene
• Procedure: evaluation of cancer risk factors

DISEASE CHARACTERISTICS:

• At risk for developing invasive breast cancer by virtue of 1 of the following criteria:
• Gail model risk equal to that of an average 60 year old woman as determined using the Gail risk assessment model
• Lobular neoplasia
• Atypical ductal hyperplasia with a positive family history of breast cancer
• Ductal carcinoma in situ previously treated with mastectomy or lumpectomy and radiation
• BRCA1 or BRCA2 mutation-positive genotyping
• Family history consistent with hereditary cancer syndrome of increased breast cancer risk defined as 1 of the following:
• Family with more than 2 breast cancer cases and one or more cases of ovarian cancer diagnosed at any age
• Family with more than 3 breast cancer cases diagnosed before age 50
• Sister pairs with 2 breast cancers, 2 ovarian cancers, or 1 breast and 1 ovarian cancer diagnosed before age 50
• Premenopausal
• Menstrual cycle of 26-35 days
• No change in menstrual pattern within the past 6 months (no irregularities)
• FSH level less than 20 mIU/mL
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS:

• Age
• 23 to 47
• Sex
• Female
• Menopausal status
• Premenopausal
• Performance status
• Not specified
• Life expectancy
• Not specified
• Hematopoietic
• No history of bleeding disorder
• Hepatic
• No history of cirrhosis of the liver
• SGOT/SGPT no greater than 3 times upper limit of normal (ULN)
• Renal
• Creatinine no greater than 1.7 mg/dL
• Cardiovascular
• No history of pulmonary embolism or deep venous thrombosis
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile participants must use effective non-hormonal contraception (e.g. barrier methods, spermicides, or surgical methods) during and for 3 months after study
• No history of infertility with a suspected ovarian etiology or recurrent ovarian cysts
• No allergy to raloxifene
• No dysfunctional uterine bleeding
• No menorrhagia
• No cervical dysplasia or significant uterine pathology requiring concurrent surgery
• No medical or psychiatric disorder that would preclude study participation
• Normal CA 125 levels

PRIOR CONCURRENT THERAPY:

• Biologic therapy
• Not specified
• Chemotherapy
• Not specified
• Endocrine therapy
• At least 6 months since prior steroid therapy (e.g., tamoxifen, estrogen, DHEA, anabolic steroids, or oral contraceptives)
• Radiotherapy
• See Disease Characteristics
• Surgery
• See Disease Characteristics
• No prior hysterectomy

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 23 Years

Maximum Age for this Clinical Trial: 47 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Cancer Institute (NCI)

Overall Clinical Trial Officials and Contacts

Jennifer Eng-Wong, MD Study Chair National Cancer Institute (NCI)  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00019500

Study ID Number: CDR0000066428

ClinicalTrials.gov Identifier: NCT00019500

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database