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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06831955 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 absent or minimal (≤10%) expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR absent or minimal (≤10%) expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 absence of HER2 protein over-expression per ASCO/CAP-guidelines is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify