Status:
COMPLETED
Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-45 years
Brief Summary
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by decreasing estrog...
Detailed Description
OBJECTIVES: Primary * Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast cancer risk reduction
- Undergoing mammography at least annually
- No bilateral breast cancer or stage IV breast cancer
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 20 to 45
- Sex
- Female
- Menopausal status
- Premenopausal
- No change in menstrual patterns within the past 6 months
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- Not pregnant or nursing
- No planned pregnancy within the next 5 years
- No medical or psychiatric disorder that would preclude giving informed consent
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for breast cancer
- Endocrine therapy
- See Disease Characteristics
- No prior tamoxifen for more than 1 month in duration
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
February 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00086749
Start Date
February 1 2003
End Date
December 1 2007
Last Update
July 11 2012
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013