Phase 2
N=321
Soy Protein and Breast Cancer Risk Reduction
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00204477 ↗Enrolled (actual)
321
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Mammographic Density (Baseline) — 29.21; 28.24 percentage of glandular tissue in breast
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- soy milk (Dietary_supplement); cow's milk (Dietary_supplement)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mammographic Density (Baseline) |
29.21; 28.24 | — |
| PRIMARY Mammographic Density (1 Year) |
29.37; 28.01 | — |
| PRIMARY Mammographic Density (2 Years) |
30.75; 29.06 | — |
| PRIMARY Breast Tissue Composition Measured by MRI |
629.9; 615.5; 173.8; 152.7; 803.7; 768.2 | — |
| PRIMARY Breast Tissue Composition Measured by MRI |
629.9; 615.5; 173.8; 152.7; 803.7; 768.2 | — |
| PRIMARY Breast Tissue Composition Measured by MRI |
629.9; 615.5; 173.8; 152.7; 803.7; 768.2 | — |
| PRIMARY Percentage of Grandular Tissue in Total Breast Measured by MRI |
26.39; 24.25 | — |
| PRIMARY Percentage of Grandular Tissue in Total Breast Measured by MRI |
26.39; 24.25 | — |
| PRIMARY Percentage of Grandular Tissue in Total Breast Measured by MRI |
26.39; 24.25 | — |
Summary
Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.
Eligibility Criteria
Inclusion Criteria
- healthy premenopausal women
- 30 to 40 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, and lifting
- on oral contraceptive medications or exogenous hormones
- medically prescribed diets
- allergic reaction to soy or cow's milk
Data sourced from ClinicalTrials.gov (NCT00204477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.