A retrospective observational clinical study of triple negative breast cancer cases treated with Di Bella Method: A preliminary data.

Objectives: Triple negative breast cancer (TNBC) is a distinct subtype of breast cancer that has a poor prognosis due to the lack of effective therapeutic agents. Since a significant proportion of human surgical samples of TNBC expressed mRNA for the growth hormone (GH), growth hormone-releasing hormone (GHRH), and gonadotropin-releasing hormone (GnRH) receptors, and the mitogenic proliferative activity of GH, GHRH, and GnRH, have been identified as effective therapeutic targets for somatostatin and its analogs and GnRH analogs, Di Bella Method (DBM), a combination of hormonal analogs and vitamins, was introduced to target and inhibit solid tumors. The present study aimed to improve the prognosis of TNBC using DBM in women with TNBC.

Methods: This retrospective observational clinical study was done on women with TNBC who were diagnosed based on histology, nuclear grade, and immunohistochemical testing for estrogen receptor, HER2/neu, and progesterone receptor. Patients were either treated with standard oncology protocol, including chemotherapy and radiotherapy plus DBM, or with DBM alone. The DBM included a daily combination of somatostatin, octreotide, melatonin, retinoids solubilized in alpha tocopheryl acetate, dopaminergic agonists, bromocriptine, cabergoline, aromatase inhibitors for anti-estrogen function, and low metronomic doses of cyclophosphamide.

Results: In this study, 35 patients were enrolled, and their survival was monitored for 5 years during which they received DBM and standard chemotherapy/radiotherapy protocol. These patients had a survival rate of 64% at 5 years, 76% at 3 years, 87% at 2 years, and 100% after 1 year of therapy. On the other hand, 13 patients who received only DBM had a survival rate of 60% at 5 years, 67% at 3 years, 75% at 2 years and 100% after 1 year of therapy. None of the patients had significant adverse events.

Conclusions: Compared to published clinical trials, the DBM improved the prognosis of women with TNBC. However, more standardized clinical trials, including DBM with and without standard therapeutic protocols for TNBC, are warranted.