Thymalfasin Combined With Chemotherapy and Immunotherapy in TNBC Neoadjuvant Treatment

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07884201
Lead Sponsor Fudan University
Conditions
(from sponsor)
Breast Cancer, TNBC - Triple-Negative Breast Cancer, Immunotherapy
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 572 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov