Nab-P+Cb+PD1 Inhibitor Combined/not Combined with Bevacizumab Neoadjuvant Therapy for Early TNBC: a Single Center, Non Blinded, Randomized Phase II Clinical Trial
We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab combined/not combined with bevacizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.
• Age: 18-65 years old;
• Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis;
• Three negative type and invasive breast cancer confirmed by histopathology;
• Three negative breast cancer is defined as:
⁃ ER and PR negative (IHC nuclear staining\<10%)
⁃ Her-2 negative (IHC 0, 1+without FISH, or IHC 2+without FISH amplification)
• Clinically measurable lesions:
• Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening;
• Organ and bone marrow function tests within 2 weeks before chemotherapy indicate no contraindications for chemotherapy:
‣ Absolute value of neutrophil count ≥ 2.0 × 109/L
⁃ Hemoglobin ≥ 100g/L
⁃ Platelet count ≥ 100 × 109/L
⁃ Total bilirubin\<1.5 ULN (upper limit of normal)
⁃ Creatinine\<1.5 × ULN
⁃ AST/ALT \< 1.5×ULN;
⁃ Urine test: Urine protein\<2+; If urine protein is ≥ 2+, the 24-hour urine protein quantification display must show protein ≤ 1g
⁃ Thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); If there are abnormalities, T3 and T4 levels should be examined. If T3 and T4 levels are normal, they can be selected
⁃ Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN, while meeting international standards Normalization ratio (INR) ≤ 1.5 ULN (not receiving anticoagulant therapy);
• Cardiac ultrasound EF value ≥ 55%;
• Women of childbearing age who tested negative for serum pregnancy test 14 days before randomization;
• ECOG score ≤ 1 point;
• Voluntary signing of informed consent