Reduction of Neoadjuvant Treatment in Early Triple-Negative Breast Cancer

Summary

This multicenter phase II study evaluates a de-escalation strategy of neoadjuvant chemo-immunotherapy in patients with stage II early triple-negative breast cancer and tumor-infiltrating lymphocytes (TILs) ≥ 30%. Patients will receive 12 weeks of neoadjuvant treatment with carboplatin, paclitaxel, and pembrolizumab. The primary objective is to assess the efficacy of this treatment strategy by evaluating the proportion of patients with no suspected residual tumor on breast MRI and biopsy after 12 weeks of neoadjuvant therapy, confirmed by pathological examination of the surgerey sample.

Timeline

Start

2026-11

Primary completion

2029-02

Completion

2032-11

Drugs

Indications