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

NCT ID: NCT00086749

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.
* Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug.
* Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug.

Secondary

* Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients.
* Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug.

OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction).

Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Conditions

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Breast Cancer

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tamoxifen group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Northwestern University

Principal Investigators

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Seema A. Khan, MD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

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Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NU-NCI-00B2

Identifier Type: -

Identifier Source: secondary_id

NCI-00B2

Identifier Type: -

Identifier Source: secondary_id

NCI 00B2

Identifier Type: -

Identifier Source: org_study_id