Triple Negative Breast Cancer Clinical Trial
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).
Verified date | March 2024 |
Source | Jiangsu HengRui Medicine Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Cancer Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. |
China,
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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