Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 20, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07884201). This is a study registration, not published results. Lead sponsor: Fudan University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 572 participants (ESTIMATED). Conditions: Breast Cancer, TNBC - Triple-Negative Breast Cancer, Immunotherapy. Interventions: DRUG: Thymalfasin. Primary outcome measures: EFS , 3 years; Interferon-gamma (IFNγ) elevation rate , 3 years. Brief summary: This is a prospective, open-label, single-center, phase II, randomized controlled clinical trial involving patients with triple-negative breast cancer who meet the criteria for neoadjuvant chemotherapy (T \> 2 cm, N+). The study aims to further validate the sensitizing effect and safety of Thymalfasin in combination with neoadjuvant chemotherapy and immunotherapy by comparing the 3-year event-free survival (EFS) and IFNγ elevation rates between the group receiving Thymalfasin in combinatione with standard neoadjuvant chemotherapy and immunotherapy and the control group receiving standard neoadjuvant chemotherapy and immunotherapy alone.