Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Raloxifene in Preventing Breast Cancer in Premenopausal Women

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Completed 23 to 47 NCI NCI-98-C-0123 MB-402, NCT00019500

Objectives

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

Entry Criteria

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

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

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

Expected Enrollment

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

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.

Orzano JA, Prindiville S, Zujewski J, et al.: Mammographic density is not modulated by raloxifene in pre-menopausal women at high-risk for invasive breast cancer. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-4035, 2004.

Eng-Wong J, Hursting SD, Venzon D, et al.: Effect of raloxifene on insulin-like growth factor-I, insulin-like growth factor binding protein-3, and leptin in premenopausal women at high risk for developing breast cancer. Cancer Epidemiol Biomarkers Prev 12 (12): 1468-73, 2003.[PUBMED Abstract]

Eng-Wong J, Stratton P, Forman M, et al.: Effect of raloxifene on menstrual cycle length and quality of life in premenopausal women at high risk for invasive breast cancer. [Abstract] American Association for Cancer Research: Frontiers in Cancer Prevention Research, October 26 - 30, 2003, Phoenix, AZ. 12: A-193, 1300s, 2003.

Premkumar A, Stratton P, Johnson D, et al.: Long term effects of raloxifene on the ovary and uterus in pre-menopausal women at high risk for developing breast cancer. [Abstract] Ultrasound Obstet Gynecol 22 (Suppl 1): A-OC164, 44, 2003.

Eng-Wong J, Venzon D, Schmidt B, et al.: The effect of raloxifene on insulin-like growth factor-1 (IGF-1) and insuline-like growth factor binding protein-3 (IGFBP-3) in premenopausal women at high risk for developing breast cancer. [Abstract] American Association for Cancer Research: Frontiers in Cancer Prevention Research, October 14 -18, 2002, Boston, MA. 11: A-317, 1162s, 2002.

Premkumar A, Stratton P, Avila N, et al.: Raloxifene effects on the ovary and the uterus in premenopausal subjects at high risk for developing breast cancer - sonographic evaluation. [Abstract] Ultrasound Obstet Gynecol 20 (Supp 1): A-P174, 72, 2002.

Zujewski J, Eng-Wong J, Reynolds J, et al.: A phase 2 trial of raloxifene in premenopausal women at high risk for developing invasive breast cancer. [Abstract] Breast Cancer Res Treat 76 (Suppl 1): A-417, 2002.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Jennifer Eng-Wong, MD, Protocol chair		Ph: 301-496-5320 Email: jewong@mail.nih.gov

Registry Information
Official Title		A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer
Trial Start Date		1998-12-08
Registered in ClinicalTrials.gov		NCT00019500
Date Submitted to PDQ		1998-07-08
Information Last Verified		2005-05-26

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