PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC
NeoPD1TNBC
PD-1 Inhibitor Sintilimab Concurrent With Epirubicin Cyclophosphamide and Nab-paclitaxel as Neoadjuvant Therapy for Triple Negative Breast Cancer
1 other identifier
interventional
49
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2021
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMarch 22, 2021
March 1, 2021
2.8 years
March 19, 2021
March 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Sintilimab
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients for whom anthracycline, nab-paclitaxel or antibody therapies are contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 22, 2021
Study Start
March 1, 2021
Primary Completion
December 1, 2023
Study Completion
March 1, 2024
Last Updated
March 22, 2021
Record last verified: 2021-03