A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Status and phase
Completed
Phase 3
Conditions
Triple Negative Breast Cancer
Treatments
Drug: Camrelizumab Plus Chemotherapy
Drug: placebo+chemotherapy
Details and patient eligibility
About
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).
Enrollment
441 patients
Sex
Female
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
441 participants in 2 patient groups
Arm A
Experimental group
Treatment:
Drug: Camrelizumab Plus Chemotherapy
Arm B
Experimental group
Treatment:
Drug: placebo+chemotherapy
Trial contacts and locations
1
Loading...
Central trial contact
FEI WU; XIAOYU ZHU
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems