Phase 2
N=197
Soy Isoflavones and Breast Cancer Risk Reduction
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00204490 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Fibroglandular Tissue in Total Breast (FGBT%) — 24.94; 25.34; 24.03; 25.82 percentage of total breast tissue — p=0.071
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- isoflavones (Dietary_supplement); carbohydrate (Dietary_supplement)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fibroglandular Tissue in Total Breast (FGBT%) |
24.94; 25.34; 24.03; 25.82; 23.14; 25.36 | 0.071 |
| PRIMARY Breast Density by Mammography |
27.7; 26.73 | — |
| SECONDARY Bone Mineral Density |
1.01; 1.00; 1.06; 1.06; 1.08; 1.07 | — |
Summary
Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00204490). 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.