Erschienen in:
12.08.2021 | Clinical trial
A randomized controlled trial of metformin in women with components of metabolic syndrome: intervention feasibility and effects on adiposity and breast density
verfasst von:
Edgar Tapia, Diana Evelyn Villa-Guillen, Pavani Chalasani, Sara Centuori, Denise J. Roe, Jose Guillen-Rodriguez, Chuan Huang, Jean-Phillippe Galons, Cynthia A. Thomson, Maria Altbach, Jesse Trujillo, Liane Pinto, Jessica A. Martinez, Amit M. Algotar, H-H. Sherry Chow
Erschienen in:
Breast Cancer Research and Treatment
|
Ausgabe 1/2021
Einloggen, um Zugang zu erhalten
Abstract
Purpose
Obesity is a known risk factor for post-menopausal breast cancer and may increase risk for triple negative breast cancer in premenopausal women. Intervention strategies are clearly needed to reduce obesity-associated breast cancer risk.
Methods
We conducted a Phase II double-blind, randomized, placebo-controlled trial of metformin in overweight/obese premenopausal women with components of metabolic syndrome to assess the potential of metformin for primary breast cancer prevention. Eligible participants were randomized to receive metformin (850 mg BID, n = 76) or placebo (n = 75) for 12 months. Outcomes included breast density, assessed by fat/water MRI with change in percent breast density as the primary endpoint, anthropometric measures, and intervention feasibility.
Results
Seventy-six percent in the metformin arm and 83% in the placebo arm (p = 0.182) completed the 12-month intervention. Adherence to study agent was high with more than 80% of participants taking ≥ 80% assigned pills. The most common adverse events reported in the metformin arm were gastrointestinal in nature and subsided over time. Compared to placebo, metformin intervention led to a significant reduction in waist circumference (p < 0.001) and waist-to-hip ratio (p = 0.019). Compared to placebo, metformin did not change percent breast density and dense breast volume but led to a numerical but not significant decrease in non-dense breast volume (p = 0.070).
Conclusion
We conclude that metformin intervention resulted in favorable changes in anthropometric measures of adiposity and a borderline decrease in non-dense breast volume in women with metabolic dysregulation. More research is needed to understand the impact of metformin on breast cancer risk reduction.