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

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.

NCT Number	NCT06604858
Lead Sponsor	MedSIR Collaborators: Merk Sharp & Dohme España S.A.
Conditions	Breast Cancer, Triple Negative Breast Cancer
Enrollment	31 participants
Start Date	2025-05-29
Primary Completion	2026-07-07 (estimated)
Study Completion	2026-07-07 (estimated)
Updated on ClinicalTrials.gov	2026-07-27