Back to resultsA Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Primary Purpose
Triple Negative Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Camrelizumab Plus Chemotherapy
placebo+chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- ECOG Performance Status of 0-1.
- Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
- Tumor stage: II-III.
- Adequate hematologic and organ function.
- Must be willing to use an adequate method of contraception for the course of the study.
Exclusion Criteria:
- Has a history of breast cancer.
- Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
- Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].
- Has a diagnosis of immunodeficiency or autoimmune diseases.
- Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
- Severe pulmonary or cardiac disease.
- Known active hepatitis C virus, or known active hepatitis B virus.
- History of organ or bone marrow transplantation.
- Pregnant or breast-feeding women.
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Outcomes
Primary Outcome Measures
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery.
Secondary Outcome Measures
Event-free Survival (EFS) as assessed by Investigator.
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Disease-free Survival (DFS) as assessed by Investigator
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.
Distant Disease-free Survival (DDFS) as assessed by Investigator
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
Objective response rate (ORR) in accordance with RECIST v1.1
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.
Percentage of Participants with Adverse Events (AEs)
Full Information
NCT ID
NCT04613674
First Posted
October 29, 2020
Last Updated
February 9, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04613674
Brief Title
A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Official Title
A Multicentre, Randomized, Double-blind, Parallel-controlled Phase Ⅲ Study to Evaluate Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Patients With Early or Locally Advanced Triple Negative Breast Cancer (TNBC).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Participants will be randomized in a 1:1 ratio to Arm A (camrelizumab +chemotherapy) or Arm B (placebo + chemotherapy).
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
581 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Camrelizumab Plus Chemotherapy
Intervention Description
camrelizumab+chemotherapy
Intervention Type
Drug
Intervention Name(s)
placebo+chemotherapy
Intervention Description
placebo+chemotherapy
Primary Outcome Measure Information:
Title
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery.
Time Frame
Up to approximately 24 weeks
Secondary Outcome Measure Information:
Title
Event-free Survival (EFS) as assessed by Investigator.
Description
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Time Frame
At least 2 years
Title
Disease-free Survival (DFS) as assessed by Investigator
Description
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.
Time Frame
At least 2 years
Title
Distant Disease-free Survival (DDFS) as assessed by Investigator
Description
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
Time Frame
At least 2 years
Title
Objective response rate (ORR) in accordance with RECIST v1.1
Description
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.
Time Frame
Up to approximately 24 weeks
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Up to approximately 67 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ECOG Performance Status of 0-1.
Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
Tumor stage: II-III.
Adequate hematologic and organ function.
Must be willing to use an adequate method of contraception for the course of the study.
Exclusion Criteria:
Has a history of breast cancer.
Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].
Has a diagnosis of immunodeficiency or autoimmune diseases.
Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
Severe pulmonary or cardiac disease.
Known active hepatitis C virus, or known active hepatitis B virus.
History of organ or bone marrow transplantation.
Pregnant or breast-feeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XIAOYU ZHU
Phone
0518-85453845
Email
zhuxiaoyu@hrglobe.cn
First Name & Middle Initial & Last Name or Official Title & Degree
FEI WU
Phone
0518-85453845
Email
wufei@hrglobe.cn
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZHIMIN SHAO, PhD, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
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