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 up to 25 mm by mammogram and/or ultrasound, or ≤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.

After signing informed consent form (ICF) and confirmed eligibility, eligible patients with localized TNBC, node-negative status, and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer (N=30) will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery as indicated below: * Pembrolizumab: 200 mg, every three weeks (Q3W), intravenously (IV) on day 1 (D1) of each cycle. * Carboplatin: area under the curve (AUC) 1.5, IV on D1, D8 and D15 of each 21-days cycle. * Paclitaxel: 80 mg/m2, IV on D1, D8 and D15 of each 21-days cycle. The treatment is composed by 4 cycles of 21 days each (patients will be treated for a total of 84 days) and treatment will last until surgery. Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected, until end of study (EoS) or study termination, whichever occurs first.