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Exercise Therapy / Triple Negative Breast Cancer (TNBC), Early Setting / SOC · Phase 2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a recruiting Phase 2 multicentric RCT investigating whether cyclic fasting-mimicking diet combined with exercise enhances neoadjuvant chemo/immunotherapy efficacy in triple negative breast cancer. No efficacy, safety, or tolerability results are posted in this registry record.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Triple Negative Breast Cancer (TNBC), Early Setting; age from 18 Years. Intervention: Arm B: Intervention arm. Compared with: Arm A: control arm — Active Comparator. n = 356. 10 sites: Belgium.
This is a recruiting Phase 2 multicentric RCT investigating whether cyclic fasting-mimicking diet combined with exercise enhances neoadjuvant chemo/immunotherapy efficacy in triple negative breast cancer. No efficacy, safety, or tolerability results are posted in this registry record.
Registry record only; no efficacy, safety, or outcome results are reported.
The source did not state who this applies to in practice.
This is a recruiting Phase 2 RCT with no posted results; the registry record describes planned interventions and outcomes only, not efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06831955). This is a study registration, not published results. Lead sponsor: Universitaire Ziekenhuizen KU Leuven. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 356 participants (ESTIMATED). Conditions: Triple Negative Breast Cancer (TNBC), Early Setting. Interventions: OTHER: Exercise Therapy; DIETARY_SUPPLEMENT: Fasting-Mimicking Diet; DRUG: SOC. Primary outcome measures: Pathological Complete Response (pCR) , Surgical specimen (at the time of surgery). Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.