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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04613674
Other study ID # SHR1210-III-322
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 9, 2020
Est. completion date March 5, 2024

Study information

Verified date March 2024
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 441
Est. completion date March 5, 2024
Est. primary completion date September 14, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Drug:
Camrelizumab Plus Chemotherapy
camrelizumab+chemotherapy
placebo+chemotherapy
placebo+chemotherapy

Locations

Country Name City State
China Fudan University Cancer Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to approximately 24 weeks
Secondary 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. At least 2 years
Secondary 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. At least 2 years
Secondary 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. At least 2 years
Secondary 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. Up to approximately 24 weeks
Secondary Percentage of Participants with Adverse Events (AEs) Up to approximately 67 weeks
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