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Updated: Jun 4, 2025
Studying Triple Negative Breast Cancer Using Orthotopic Breast Cancer Model
Published on: March 20, 2020
A retrospective observational clinical study of triple negative breast cancer cases treated with Di Bella Method: A
Giuseppe Di Bella1, Ilaria Moscato1, Elena Costanzo1
1Di Bella Foundation, Via Guglielmo Marconi 51 Bologna, 40122 Italy.
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 women with TNBC using DBM.
Methods:
This retrospective observational 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.
Insights
The Di Bella Method (DBM) shows promise in improving survival rates for triple-negative breast cancer (TNBC) patients. This combination therapy, including hormonal analogs and vitamins, demonstrated positive outcomes with minimal adverse events in a small study.
Area of Science:
- Oncology
- Endocrinology
- Pharmacology
Background:
- Triple-negative breast cancer (TNBC) presents a significant clinical challenge due to its aggressive nature and limited targeted therapies.
- Expression of growth hormone (GH), GH-releasing hormone (GHRH), and gonadotropin-releasing hormone (GnRH) receptors in TNBC suggests potential therapeutic targets.
- The Di Bella Method (DBM), a multimodal approach combining hormonal analogs and vitamins, has been investigated for its anti-tumor effects.
Purpose of the Study:
- To evaluate the efficacy of the Di Bella Method (DBM) in improving the prognosis of patients diagnosed with triple-negative breast cancer (TNBC).
- To assess the impact of DBM, both in combination with standard treatments and as a standalone therapy, on TNBC patient survival rates.
Main Methods:
- A retrospective observational study involving women diagnosed with TNBC.
- Patients received either standard oncology protocols (chemotherapy, radiotherapy) combined with DBM, or DBM alone.
- DBM comprised a daily regimen including somatostatin, octreotide, melatonin, retinoids, dopaminergic agonists, and low-dose cyclophosphamide.
Main Results:
- In patients receiving DBM with standard therapy (n=35), 5-year survival rates were 64%, with 100% survival at 1 year.
- Patients treated with DBM alone (n=13) showed a 5-year survival rate of 60%, with 100% survival at 1 year.
- No significant adverse events were reported in any patient group.
Conclusions:
- The Di Bella Method (DBM) appears to improve the prognosis for women with triple-negative breast cancer (TNBC) when compared to historical data.
- Further standardized clinical trials are necessary to definitively establish the role of DBM, with and without standard therapies, in TNBC treatment.
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