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Mammographic Density and Soy Isoflavones

Phase 2
30 Years
42 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Mammographic Density and Soy Isoflavones

This is a randomized, double-blind study, with two arms and 100 women in each arm.
Premenopausal women will be recruited and randomly allocated to take one of the two
different dietary supplements in pills daily for 2 years. The two supplements are soy
isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will
contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be
obtained before and during the dietary supplement periods and analyzed for biomarkers of
breast cancer risk. At baseline and after the intervention period, breast density and bone
density will be assessed by radiologic techniques. The efficacy of the dietary intervention
will be determined by comparing mean changes of serum markers for breast cancer risk,dense
breast tissue, and bone mineral density over the two year dietary intervention period in the
two supplement groups with adjustment for baseline values and individual patient
characteristics of interest. We predict that 2 years of soy isoflavone supplement will
reduce breast density, which may be explained by individual changes in serum markers of
breast cancer risk.

Inclusion Criteria:

- healthy premenopausal women

- 30 to 42 years old

- normal mammograms

- regular menstrual cycles

Exclusion Criteria:

- abnormal mammograms

- first degree relatives with breast cancer

- pregnant or lactating

- peri- or post-menopause

- breast augmentation, reduction or lifting

- on oral contraceptive medications or exogenous hormones

- medically prescribed diets

- allergic reaction to soy products

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Breast density

Outcome Time Frame:

one or two years after dietary supplements

Safety Issue:


Principal Investigator

Lee-Jane W Lu, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Teas Medical Branch


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • soy
  • isoflavones
  • phytoestrogens
  • prevention
  • mammographic density
  • bone density
  • Breast Neoplasms



General Clinical Reserach Center, The University of Texas Medical Branch Galveston, Texas  77555-0264