OncoMatch/Clinical Trials/NCT06831955
LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer
Is NCT06831955 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies SOC for triple negative breast cancer (tnbc), early setting.
Treatment: SOC — LESLIE is a multicentric randomized controlled trial in patients with triple negative breast cancer receiving neoadjuvant chemo/immunotherapy (NAT). This trial investigates the hypothesis that adding a cyclic fasting-mimicking diet combined with exercise during the NAT improves the NAT's therapeutic efficacy, treatment tolerability and compliance, as well as improve quality of life.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 absent or minimal (≤10%) expression (≤10%)
ER and PR negative is defined as an absent or minimal (≤10%) expression of oestrogen and progesterone receptors
Required: PR (PGR) absent or minimal (≤10%) expression (≤10%)
ER and PR negative is defined as an absent or minimal (≤10%) expression of oestrogen and progesterone receptors
Required: HER2 (ERBB2) absence of HER2 protein over-expression per ASCO/CAP-guidelines (negative)
absence of HER2 protein over-expression per ASCO/CAP-guidelines
Disease stage
Required: Stage II, III
Performance status
WHO/ECOG 0–1
Prior therapy
Cannot have received: chemotherapy
Exception: none within 5 years of the first dose of study treatment
any other chemotherapy, immunotherapy or anticancer agents within 5 years of the first dose of study treatment
Cannot have received: immunotherapy
Exception: none within 5 years of the first dose of study treatment
any other chemotherapy, immunotherapy or anticancer agents within 5 years of the first dose of study treatment
Cannot have received: anticancer agents
Exception: none within 5 years of the first dose of study treatment
any other chemotherapy, immunotherapy or anticancer agents within 5 years of the first dose of study treatment
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
adequate bone marrow function
Kidney function
Liver function
Presence of adequate bone marrow and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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