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Retlirafusp alfa+TP-AC / Triple Negative Breast Cancer (TNBC) / Retlirafusp alfa+Nab-paclitaxel: · Phase 2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 registration for a planned trial of retlirafusp alfa (a novel immunotherapy) combined with chemotherapy or fluzoparib (PARP inhibitor) in triple-negative breast cancer. No results are posted; the study has not yet begun recruitment. The trial is designed to evaluate objective response rate in advanced disease and pathological complete response in the neoadjuvant setting, with a 6-month analysis cutoff.
Phase 2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Triple-Negative Breast Cancer (TNBC); Female; age from 18 Years; to 100 Years. Intervention: Advanced cohort: gBRCA1/2 wild-type; Advanced cohort: gBRCA1/2 pathogenic or likely pathogenic m…; Early neoadjuvant cohort: gBRCA1/2 wild-type; Early neoadjuvant cohort: gBRCA1/2 pathogenic or likely pat…. n = 120. 1 site: China.
This is a Phase 2 registration for a planned trial of retlirafusp alfa (a novel immunotherapy) combined with chemotherapy or fluzoparib (PARP inhibitor) in triple-negative breast cancer. No results are posted; the study has not yet begun recruitment. The trial is designed to evaluate objective response rate in advanced disease and pathological complete response in the neoadjuvant setting, with a 6-month analysis cutoff.
Registry record only; no efficacy or safety results posted
The source did not state who this applies to in practice.
Phase 2 interventional trial in planning stage with no posted results; early-phase design studying a novel immunotherapy combination in TNBC.
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 (NCT07752550). This is a study registration, not published results. Lead sponsor: Harbin Medical University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Triple-Negative Breast Cancer (TNBC). Interventions: DRUG: Retlirafusp alfa+Nab-paclitaxel:; DRUG: Retlirafusp alfa+Fluzoparib; DRUG: Retlirafusp alfa+TP-AC; DRUG: Retlirafusp alfa+Fluzoparib. Primary outcome measures: Late-Stage Cohort-Objective Response Rate , Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.; Neoadjuvant Cohort-tpCR (ypT0/is ypN0) , Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.. Brief summary: To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.