Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial
Trial Parameters
Brief Summary
Italian, multicenter, open-label, two-arm, comparative, randomized phase II study investigating if the addition of the experimental metabolic intervention consisting in cycles of Fasting-Like Approach, as administered every three weeks up to a maximum of 8 consecutive cycles, is able to increase the anticancer activity of standard preoperative chemo-immunotherapy in patients with localized invasive Triple Negative Breast Cancer.
Eligibility Criteria
Inclusion Criteria: 1. Female sex 2. Age ≥ 18 and ≤ 75 years. 3. Evidence of a personally signed and dated informed consent document (ICD), signed and dated from the patient of legal representative with or without an impartial witness, indicating that the patient has been informed of all pertinent aspects of the study before enrollment 4. Willingness and ability to comply with the prescribed FLA regimen, the scheduled visits, treatment plans, laboratory tests and other procedures. 5. Histologically confirmed diagnosis of invasive TNBC candidate to neoadjuvant chemo-immunotherapy and subsequent curative surgery. On the basis of International Guidelines, TNBC is defined by absent or minimal (\<1%) expression of oestrogen and progesterone receptors at IHC, and absence of HER2 protein over-expression and HER2 gene amplification, as defined as an IHC score of 0, 1+, or an IHC score of 2+ with in situ hybridization (ISH) analysis excluding HER2 gene amplification. The expression of hormone r