Protocol Number: 98-C-0123

Title:

A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer

Number:

98-C-0123

Summary:

This is an open-label phase II trial designed to study the safety and tolerability of raloxifene, a selective estrogen receptor modulating agent, in pre-menopausal women at high risk of developing invasive breast cancer. Two doses of raloxifene will be studied in sequential cohorts: a 60 mg dose (standard dose) and a 300 mg dose administered daily for 2 years. The primary objective of this trial will be to determine the safety of raloxifene in a pre-menopausal population using bone mineral density as the primary endpoint. Secondary objectives include assessment of endogenous hormones and lipid levels, menstrual cycle effects, effects on endometrium and ovaries, health related quality of life, and breast density. Tissue samples will be obtained for future studies of potential surrogate endpoint biomarkers.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Bone Mineral Density

Steroid Hormones

MRI

Biomarkers

Lipids

Recruitment Keywords:

None

Conditions:

Breast Cancer

Breast Neoplasm

Investigational Drug(s):

Raloxifene

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Reproductive endocrine and endometrial effects of raloxifene hydrochloride, a selective estrogen receptor modulator, in women with regular menstrual cycles

Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women

Chemoprevention of mammary carcinogenesis in the rat: combined use of raloxifene and 9-cis retinoic acid

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004