A randomized controlled trial of metformin in women with components of metabolic syndrome: intervention feasibility and effects on adiposity and breast density

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, randomize...

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Veröffentlicht in:Breast cancer research and treatment 2021-11, Vol.190 (1), p.69-78
Hauptverfasser: Tapia, Edgar, Villa-Guillen, Diana Evelyn, Chalasani, Pavani, Centuori, Sara, Roe, Denise J., Guillen-Rodriguez, Jose, Huang, Chuan, Galons, Jean-Phillippe, Thomson, Cynthia A., Altbach, Maria, Trujillo, Jesse, Pinto, Liane, Martinez, Jessica A., Algotar, Amit M., Chow, H-H. Sherry
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Sprache:eng
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Zusammenfassung: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  
ISSN:0167-6806
1573-7217
DOI:10.1007/s10549-021-06355-9