Clinical Trial: NCT06604858
Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | MedSIR |
| Information Provided By: | MedSIR |
| Last Update Posted: | 2026-07-27 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Pembrolizumab
- Drug: Carboplatin
- Drug: Paclitaxel
Other Study ID Numbers
- MedOPP599
- 2024-513511-27-00
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | MedSIR |
| Information Provided By: | MedSIR |
| Last Update Posted: | 2026-07-27 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Pembrolizumab
- Drug: Carboplatin
- Drug: Paclitaxel
Other Study ID Numbers
- MedOPP599
- 2024-513511-27-00