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NCT04809779 Clinical Trial

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

Triple Negative Breast Cancer Clinical Trial

— NeoPD1TNBC  

Official title:
PD-1 Inhibitor Sintilimab Concurrent With Epirubicin Cyclophosphamide and Nab-paclitaxel as Neoadjuvant Therapy for Triple Negative Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04809779
Other study ID # 2020466
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 2021
Est. completion date March 2024

Study information
Verified date March 2021
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Nan Shao
Phone 02087755766
Email shaon@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 49
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sintilimab
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.

Locations
Country Name City State
China The First Affiliated Hospital of Sun Yat-sen University Guangzhou

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pathologic Complete Response (pCR) Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0). 21 weeks
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