Back to resultsPD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC (NeoPD1TNBC)
Primary Purpose
Triple Negative Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility 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.
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sintilimab
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04809779
First Posted
March 19, 2021
Last Updated
March 19, 2021
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT04809779
Brief Title
PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC
Acronym
NeoPD1TNBC
Official Title
PD-1 Inhibitor Sintilimab Concurrent With Epirubicin Cyclophosphamide and Nab-paclitaxel as Neoadjuvant Therapy for Triple Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sintilimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pathologic Complete Response (pCR)
Description
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).
Time Frame
21 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Shao
Phone
02087755766
Ext
8198
Email
shaon@mail.sysu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC
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