In addition to the studies in the rat model, the effects of MLT have also been investigated in human breast cancer. It has been reported that the nocturnal rise in MLT levels is significantly reduced in women with ER-positive breast tumors compared to women with ER-negative breast tumors and healthy age-matched controls (24). Another clinical study assessing pineal function in patients with breast cancer found that post-menopausal women with advanced breast cancer have diminished urinary levels of MLT compared to healthy controls (25). Based on these data, it has been suggested that depressed MLT secretion may be a predisposing factor for the development of breast cancer in humans (26). It has also been reported that a two-fold higher MLT level is associated with breast tumors with a low proliferative index compared to those with a high index, suggesting that hypersecretion of MLT may predict a more favorable prognosis (27). Clinical trials investigating the combined effects of MLT with tamoxifen are also promising. Lissoni et al. (28) initiated a clinical phase II study to assess the efficacy of combined treatment using tamoxifen and MLT in women with metastatic breast cancer who were unresponsive to tamoxifen therapy alone. Twenty-eight percent of the patients exhibited a partial response to treatment with MLT and tamoxifen, indicating that MLT may amplify the effects of tamoxifen in women with metastatic breast cancer, and may induce tumor regression in patients who have previously not responded to tamoxifen therapy. However, despite this positive data on the oncostatic effects of MLT, very few clinical trials have been conducted investigating the role of MLT in human breast cancer.
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