Thymalfasin Combined With Chemotherapy and Immunotherapy in TNBC Neoadjuvant Treatment

Conditions: Breast Cancer, TNBC - Triple-Negative Breast Cancer, Immunotherapy

Sex: Female

Ages: 18 Years – 70 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 572

Sponsor: Fudan University

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.

Eligibility Criteria

Inclusion Criteria: \- Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. Female aged 18 to 70 years; 2. Histologically confirmed unilateral primary invasive breast cancer, planned to undergo neoadjuvant therapy (chemotherapy or at least 6 cycles of ADC therapy combined with immunotherapy); 3. Immunohistochemistry (IHC) confirmed triple-negative breast cancer (ER \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07884201). StuddyBuddy aggregates publicly available trial information.