A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jiangsu HengRui Medicine Co., Ltd.
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
