drugset / Trial / NCT06604858
Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 225 mg | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |