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Are you concerned about your risk of developing breast cancer?

Breast cancer risk is increased for women with a family history of the disease, those who have had a breast biopsy showing abnormal (or atypical) cells and those with dense breasts. Currently, Tamoxifen is the only medication proven to reduce breast cancer risk in premenopausal women. It protects the breast against cancer by blocking estrogen from reaching breast cells. It also reduces breast density, and studies show that reduction in breast density leads to a lowering of breast cancer risk.

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Can change in breast density be used to guide personalized dosing of Tamoxifen, so each woman receives the dose she needs to lower her risk of developing breast cancer?

Principal Investigator: 
Seema A. Khan, MD - Northwestern University

 

The standard dose for Tamoxifen is 20 mg daily, which is proven to reduce breast cancer risk effectively. But some side effects discourage women from taking it. Recent clinical trials have shown that taking Tamoxifen at a lower dose of 5 mg/day, which is one-quarter of the usual dosage, can reduce side effects and breast density. However, some premenopausal women may need a higher dose than 5 mg daily. In this study, we would like to find out whether the Tamoxifen dose can be personalized for each premenopausal woman based on decrease in breast density measured on mammograms. We will use a precise method that is more accurate than the usual mammogram report. This will allow us to use each woman’s breast density changes to give her the right amount of Tamoxifen.

 

If you decide to take part in this study, you'll undergo your routine mammogram to measure breast density, then start taking a 6-month course of low-dose Tamoxifen (5 mg/day). Depending on the reduction in breast density observed in two follow-up mammograms, the Tamoxifen dose may be continued at 5 mg, increased to 10 mg, or raised to the full 20 mg dose. You will also have physical exams, blood draws, medical history reviews and completion of questionnaires. The entire period of study participation is 18 months and reimbursement will be provided for your transportation, parking, and other study-related time and expenses.

 

We will enroll 200 women at institutions across the country. You may be eligible if you:

 

  • Are between the age of 18 and 55 years.

  • Have not reached menopause.

  • Are considered at higher-than-average risk of developing breast cancer.

  • Have no history of invasive breast cancer.

  • Are not pregnant or breastfeeding.

If you think you may be eligible, you can contact ncpc@northwestern.edu to refer you to the study team closest to you.

 

Site: Northwestern University, Chicago, IL

Investigator: Seema A. Khan, MD

 

Site: University of Kansas, Kansas City, KS

Investigator: Carol Fabian, MD, FASCO

 

Site: University of Illinois Chicago, Chicago, IL

Investigator: Kent Hoskins, MD

 

Site: Medical University of South Carolina, Charleston, SC

Investigator: Kevin S. Hughes, MD

 

Site: University of Michigan, Ann Arbor, MI

Investigator: Melissa L. Pilewskie, MD

 

Site: Washington University, St. Louis, MO

Investigator: Adetunji Toriola, MD, PhD, MPH

 

Site: University of Texas MD Anderson Cancer Center, Houston, TX

Investigator: Eduardo Vilar-Sanchez, MD, PhD

 

Site: University of Arizona, Tucson, AZ

Investigator: H.H. Sherry Chow, PhD

 

Site: Dana-Farber Cancer Institute, Boston, MA

Investigator: Tari King, MD, FACS, FSSO

 

Site: University Hospitals Cleveland Medical Center, Cleveland, OH

Investigator: Amanda L. Amin, MD

Additional Resources

Study Brochure 

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Study Video 

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Content on NUcancerprevention.org is a courtesy from the Northwestern Cancer Prevention Consortium at Northwestern University. While we strive to maintain the most current and up to date information possible, NCPC does not guarantee accuracy, completeness, or relevance of the information supplied. The thoughts, views, and information found here do not necessarily reflect the views of Northwestern University or Northwestern Medicine. 

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