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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00086749
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : July 11, 2012
National Cancer Institute (NCI)
Information provided by:
Northwestern University

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.

Condition or disease
Breast Cancer

Detailed Description:



  • 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.


  • 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.

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
Study Start Date : February 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Tamoxifen

Tamoxifen group

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


  • 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



  • 20 to 45


  • Female

Menopausal status

  • Premenopausal

    • No change in menstrual patterns within the past 6 months

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing

    • No planned pregnancy within the next 5 years
  • No medical or psychiatric disorder that would preclude giving informed consent


Biologic therapy

  • Not specified


  • No prior chemotherapy for breast cancer

Endocrine therapy

  • See Disease Characteristics
  • No prior tamoxifen for more than 1 month in duration


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00086749

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United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Principal Investigator: Seema A. Khan, MD Robert H. Lurie Cancer Center
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Responsible Party: Seema Khan, MD, Northwestern University Identifier: NCT00086749    
Other Study ID Numbers: NCI 00B2
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by Northwestern University:
breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases