study of camrelizumab plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (tnbc)

Conditions: Triple Negative Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of camrelizumab in combination with nab-paclitaxel and carboplatin as neoadjuvant therapy in participants with triple negative breast cancer (tnbc).


Eligibility criteria:
inclusion criteria: * newly diagnosed breast cancer; * 18-75 years, female; * ecog performance status of 0-1; * life expectancy is not less than 3 months; * histologically documented tnbc (negative human epidermal growth factor receptor 2 \[her2\], estrogen receptor \[er\], and progesterone receptor \[pgr\] status); * tumor stage: ii-iii; * at least one measurable lesion according to recist 1.1; * adequate hematologic and organ function.; * must be willing to use an adequate method of contraception for the course of the study. exclusion criteria: * stage ⅳ (metastatic) breast cancer or bilateral breast cancer; * inflammatory breast cancer; * has received prior any anti-tumor therapy within the past 12 months prior to signing informed consent, including chemotherapy, targeted therapy, radiation therapy, immunotherapy, biotherapy and tace; * 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 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; * major surgical procedure within 4 weeks prior to initiation of study treatment; * active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled type 1 diabetes mellitus; * has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases; * administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study; * has a known history of human immunodeficiency virus (hiv); * has known active hepatitis b, hepatitis c or autoimmune hepatitis; * severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; * has active infection (ctcae≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment; * has evidence of active tuberculosis within 1year prior to initiation of study treatment; * prior allogeneic stem cell or solid organ transplantation; * pre-existing motor or sensory neuropathy of a severity≥grade 2; * has significant cardiovascular disease; * has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; * female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; * history of neurological or psychiatric disorders, including epilepsy or dementia; * any other situation evaluated by researchers.