OncoMatch/Clinical Trials/NCT05763992
Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial
Is NCT05763992 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for breast cancer.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 absent or minimal (<1%) expression (<1% by IHC)
TNBC is defined by absent or minimal (<1%) expression of oestrogen and progesterone receptors at IHC
Required: PR (PGR) absent or minimal (<1%) expression (<1% by IHC)
TNBC is defined by absent or minimal (<1%) expression of oestrogen and progesterone receptors at IHC
Required: HER2 (ERBB2) no overexpression and no amplification (IHC 0, 1+, or 2+ with ISH negative)
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
Disease stage
Required: Stage T1CN1, T1CN2, T2N0, T2N1, T2N2, T3N0, T3N1, T3N2, T4N0, T4N1, T4N2 (TNM)
Patients with tumor stage T1c AND nodal stage N1-2, or tumor stage T2-4 AND nodal stage N0-2 according to TNM
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: except for adequately treated basal cell or squamous skin cancer or in situ cervical cancer; other malignancies diagnosed more than 5 years before the diagnosis of breast cancer must have been radically treated without evidence of relapse
Prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment, except for adequately treated basal cell or squamous skin cancer or in situ cervical cancer. Other malignancies diagnosed more than 5 years before the diagnosis of breast cancer must have been radically treated without evidence of relapse at the moment of patient enrollment in the trial.
Cannot have received: anthracycline
Prior treatment with anthracyclines
Cannot have received: anti-PD-1 therapy
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^3/l; platelets ≥ 100 x 10^3/l; hemoglobin ≥ 9.0 g/dl
Kidney function
creatinine < 1.5 ULN; blood uric acid < 10 mg/dl
Liver function
ALT and AST ≤ 2 x ULN; total bilirubin < 1.5 ULN except for patients with Gilbert syndrome who may only be included if the total bilirubin is < 3.0 x ULN or direct bilirubin < 1.5 x ULN
Cardiac function
Left ventricular ejection fraction ≥ 50% at the cardiac scan with radionuclides or at echocardiography
Presence of adequate bone marrow and organ function as defined by the following laboratory values: ... ALT and AST ≤ 2 x ULN; total bilirubin < 1.5 ULN except for patients with Gilbert syndrome who may only be included if the total bilirubin is < 3.0 x ULN or direct bilirubin < 1.5 x ULN; creatinine < 1.5 ULN; blood uric acid < 10 mg/dl; ANC ≥ 1.5 x 10^3/l; platelets ≥ 100 x 10^3/l; hemoglobin ≥ 9.0 g/dl; Left ventricular ejection fraction lower than 50% at the cardiac scan with radionuclides or at echocardiography [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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