Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

Inclusion criteria

• Newly diagnosed breast cancer.
• 18-75 Years, female.
• Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
• Tumor stage: II-III.
• ECOG Performance Status of 0-1.
• life expectancy is not less than 3 months.
• 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 TAE.
• 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], and/or anti-VEGFR agent.
• 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.
• Has a history of autoimmune disease.
• Has a history of hypertension that not well controlled by antihypertensive treatment
• Has a history of myocardial infarction, severe/unstable angina pectoris, NYHA Class 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure within the last 6 months.
• 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 1 year prior to initiation of study treatment.
• Prior allogeneic stem cell or solid organ transplantation.
• Peripheral neuropathy grade ≥2.
• Has clinically significant intestinal obstruction.
• Arterial/venous thrombosis events that occurred within 3 months before enrollment, such as cerebrovascular accidents, deep vein thrombosis, or pulmonary embolism.
• Has hemoptysis symptoms within 2 months before enrollment and the maximum daily hemoptysis ≥ 2.5 ml.
• Clinically significant bleeding symptoms or clear bleeding tendency occurred within 3 months before enrollment.
• Has known genetic or acquired bleeding or thrombotic tendency.
• Abnormal coagulation (INR>1.5 or APTT>1.5 x ULN) with bleeding tendency, receiving thrombolysis or anticoagulation therapy, or requiring long-term antiplatelet therapy.
• 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.