Status:
COMPLETED
Effect of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-50 years
Phase:
NA
Brief Summary
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. 4-hydroxytamoxifen gel (a substance made when tamoxifen breaks down in the...
Detailed Description
OBJECTIVES: Primary * Determine the effect of 4-hydroxytamoxifen gel on breast density, as measured by digital mammography, in premenopausal women. * Determine the effect of this gel on breast densi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Premenopausal as determined by a menstrual history of no change in menstrual pattern within the past 6 months
- Undergoing mammography at least annually
- No prior breast cancer
- No clinical breast abnormalities suspicious for cancer
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 30 to 50
- Sex
- Female
- Menopausal status
- See Disease Characteristics
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception
- No medical or psychiatric disorder that would preclude giving informed consent
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- More than 3 months since prior oral contraceptives or other estrogen- or progesterone-containing drugs
- No prior tamoxifen for more than 1 month duration
- No concurrent oral contraceptives or other estrogen- or progesterone-containing drugs
- No other concurrent antiestrogen medications
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00084344
Start Date
April 1 2003
End Date
July 1 2004
Last Update
May 30 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611