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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab Plus Chemotherapy | Drug | camrelizumab+chemotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39671272 | Derived | Chen L, Li H, Zhang H, Yang H, Qian J, Li Z, Ren Y, Wang S, Fu P, Yang H, Liu Y, Sun J, Nie J, Lei R, Yao Y, Zhang A, Wang S, Ma X, Ouyang Z, Yang H, Wu SY, Cao SW, Wang K, Jiang A, Ouyang Q, Pang D, Wei L, Zha X, Shen Y, Qu X, Wu F, Zhu X, Wang Z, Fan L, Shao ZM. Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer: The CamRelief Randomized Clinical Trial. JAMA. 2025 Feb 25;333(8):673-681. doi: 10.1001/jama.2024.23560. |
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| placebo+chemotherapy |
| Drug |
placebo+chemotherapy |
|
| 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 |
| 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 |
| 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 |
| Percentage of Participants with Adverse Events (AEs) | Up to approximately 67 weeks |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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