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This study analyzes an oral supplement of molecular iodine (I 2 ), alone and in combination with the neoadjuvant therapy 5-fluorouracil/epirubicin/cyclophosphamide or taxotere/epirubicin (FEC/TE) in women with Early (stage II) and Advanced (stage III) breast cancer. In the Early group, 30 women were treated with I 2 (5 mg/day) or placebo (colored water) for 7-35 days before surgery. For the Advanced group, 30 patients received I 2 or placebo, along with FEC/TE treatment. After surgery, all patients received FEC/TE + I 2 for 170 days. I 2 supplementation showed a significant attenuation of the side effects and an absence of tumor chemoresistance. The control, I 2 , FEC/TE, and FEC/TE + I 2 groups exhibited response rates of 0, 33%, 73%, and 100%, respectively, and a pathologic complete response of 18%, and 36% in the last two groups. Five-year disease-free survival rate was significantly higher in patients treated with the I 2 supplement before and after surgery compared to those receiving the supplement only after surgery (82% versus 46%). I 2 -treated tumors exhibit less invasive potential, and significant increases in apoptosis, estrogen receptor expression, and immune cell infiltration. Transcriptomic analysis indicated activation of the antitumoral immune response. The results led us to register a phase III clinical trial to analyze chemotherapy + I 2 treatment for advanced breast cancer.

Adjuvant Effect of Molecular Iodine in Conventional Chemotherapy for Breast Cancer. Randomized Pilot Study