Triple Negative Breast Cancer
Conditions
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).
Interventions
camrelizumab+chemotherapy
DRUGplacebo+chemotherapy
placebo+chemotherapy
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival (EFS) as assessed by Investigator. | At least 2 years | 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 | At least 2 years | 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 | At least 2 years | 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 | Up to approximately 24 weeks | 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) | Up to approximately 67 weeks | — |
Countries
China
Outcome results
None listed