Objective. The Russian and foreign experience with indole-3-carbinol, a substance with proven multitargeted antitumor activity, in the treatment of benign breast diseases and in the prevention of breast cancer was summarized. There are results of foreign experimental and clinical studies, and the randomized, double-blind, placebo-controlled trial of the efficacy of a drug based on indole-3-carbinol (Indinol forto) in treating cyclic mastalgia (mastodynia) and benign breast dysplasia (fibrocystic mastopathy), which was conducted in the Russian Federation in 2010-2013. Subjects and methods. This clinical trial included 62 patients aged 20 to 45 years. 30 patients received indole- 3-carbinol 400 mg/day and 32 took placebo during 6 menstrual cycles. After 6 months of therapy, its efficiency was found to be, in terms of breast tenderness, significantly higher in the Indinol forto group than in the placebo group (83.3% vs 50.3%; p = 0.002). Following 6 months of treatment, breast tenderness reduced or disappeared in 83.0% of the patients in the mastopathy subgroup (in 47.0% in the placebo group; p = 0.004). The Indinol forto group also showed an increment in the plasma level of sex steroid-binding globulin and a statistically significant rise in the ratio of urinary estrogen metabolites (2-hydroxyestrone/16α-hydroxyestrone). Results. The investigation provided evidence that the new multitargeted drug Indinol forto was effective in treating patients with cyclic mastalgia (mastodynia) and mastopathy. Considering that the known mechanisms of action of indole carbinol characterize it as an agent having a protective effect against cancer, this result is particularly important in the terms of the prevention of breast cancer in patients with cyclic mastalgia. The results of studies demonstrating the positive effect of indole-3-carbinol and 3,3’-diindolylmethane on the clinical markers of an increased risk for breast cancer (mastalgia, mastodynia, and other manifestations of fibrocystic breast disease) confirm the important role of these molecules as preventive strategies to reduce the risk of breast cancer. Conclusion. These findings have led to the conclusion that Indinol forto may be recommended for the treatment of patients with both cyclic mastalgia (mastodynia) and mastopathy. © Bionika Media Ltd.