drugset / Trial / NCT06604858

Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer

NCT06604858 ↗

Phase 2 Active not recruiting 31 enrolled MedSIR Merk Sharp & Dohme España S.A. · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, proof of concept phase II clinical trial to evaluate the combination of Pembrolizumab and Carboplatin plus Paclitaxel in patients with localized TNBC (tumor size ≥ 10 mm and ≤ 20 mm by mammogram and/or ultrasound, and/or ≥ 10 mm and ≤ 25 mm by breast MRI if performed within 2 weeks after biopsy, considering possible tissue inflammation post-procedure, as per local assessment), node-negative status (by clinical exam and local radiological evaluation) and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer.

Timeline

Start
2025-05-29
Primary completion
2026-08
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 225 mg Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous