Raloxifene in Preventing Breast Cancer in Premenopausal Women

June 18, 2013 updated by: National Cancer Institute (NCI)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Medicine Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

June 22, 2005

First Posted (Estimate)

June 23, 2005

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066428
  • NCI-98-C-0123
  • MB-402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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