Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer

NCT00086749 | Completed

• 3 other identifiers: NCI 00B2NU-NCI-00B2NCI-00B2
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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 estrogen levels. PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer.

Conditions

Breast Cancer

Keywords

breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Study Arms (1)

Tamoxifen group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who are initiating tamoxifen on the advice of their treating physician as the sole systemic treatment for breast carcinoma or breast cancer risk reduction

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seema A. Khan, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: February 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

US (1)