Overview

PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC

Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Criteria
Inclusion Criteria:

- Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative
invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic
chemotherapy would be indicated based on physician judgment following standard NCCN
practice guidelines.

Exclusion Criteria:

- Patients for whom anthracycline, nab-paclitaxel or antibody therapies are
contraindicated.