Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer

Korábbi kezelés

• Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment;
• Administration of a live attenuated vaccine within 30 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study;
• Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment;
• Prior allogeneic stem cell or solid organ transplantation
• Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

Más betegség

• 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, including pulmonary fibrosis, acute lung disease, etc.;
• Has a history of serious cardiovascular disease, including myocardial infarction, acute coronary syndrome or coronary angioplasty/stent implantation/bypass grafting history in the past 6 months, and have level II-IV congestion Heart failure (CHF), or III NYHA and IV CHF history;
• History of neurological or psychiatric disorders, including schizophrenia, severe depressive disorder, bipolar disorder, etc.;
• History of severe hypersensitivity reactions to other monoclonal antibodies, or intravenous infusion, or Doxorubicin, or cyclophosphamide, or paclitaxel, or carboplatine

Laborértékek

• Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies;

Életkor

• 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;
• 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;

Egyéb

• Any other situation evaluated by researchers.

• 18-65 Years, female; 2) Histologically documented Triple Negative Breast Cancer (TNBC) patients; 3) Previously untreated non-metastatic (M0) TNBC, T3-4NanyM0 или TanyN+M0 3) Promising radical surgical treatment; 4) At least one measurable lesion according to RECIST 1.1; 5) Life expectancy is not less than 3 months; 6) ECOG: 0～1; 7) Adequate function of major organs meets the following requirements:
• Neutrophils ≥ 1.5×10\^9/L Hemoglobin ≥ 90g/L Platelets ≥ 100×10\^9/L Total bilirubin≤ 1.5 × the upper limit of normal (ULN) ALT and AST ≤ 2.5 × ULN Serum creatinine ≤1.5 × ULN, Endogenous creatinine clearance ≥50mL/min;
• Left ventricular ejection fraction (LVEF) ≥50% or ≥ limit of normal (LLN) was evaluated by echocardiography (ECHO) or Multigated Acquisition (MUGA); 10) Women with childbearing potential who are must agree to take effective contraceptive measures during the study period and ≥120 days after the last administration of the study drug, and must have a negative serum pregnancy test result within 7 days prior to initiation of study drug.
• The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up;