pyrotinib in her2-positive early breast cancer

Conditions: HER2-positive Breast Cancer

Summary: this is a multi-cohort, phase ii clinical study of neoadjuvant - adjuvant pyrotinib in the treatment of her2-positive early breast cancer, to evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early her2-positive early breast cancer with neoadjuvant and postoperative different residual tumor burden (rcb) scores.

this is a multi-cohort, phase ii clinical study of neoadjuvant - adjuvant pyrotinib in the treatment of her2-positive early breast cancer, to evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early her2-positive early breast cancer with neoadjuvant and postoperative different residual tumor burden scores.

Eligibility criteria:
inclusion criteria: 1. women aged ≥18 years and ≤75 years with newly treated breast cancer; 2. pathological examination confirmed her2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and fluorescence in situ hybridization positive); 3. patients with invasive breast cancer diagnosed histologically plus imaging as early (t1c-3, n0-1, m0) or locally advanced (t2-3, n2, or n3, m0); 4. eastern cooperative oncology group score 0\~1; 5. plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (sn) biopsy or axillary lymph node dissection (alnd); 6. if the major organs function normally, the following criteria are met: (1) the standard of blood routine examination should meet: absolute neutrophil count(anc) ≥1.5×109/l; blood platelet (plt) ≥90×109/l; hb ≥90g/l; (2) biochemical examination should meet the following criteria: total bilirubin(tbil)≤ upper limit of normal value (uln); alanine aminotransferase(alt) and ast≤1.5 times the upper limit of normal (uln); alkaline phosphatase ≤2.5 times the upper limit of normal (uln); blood urea nitrogen(bun)and cr≤1.5×uln and creatinine clearance ≥50 ml/min (cockcroftgault formula); (3) color doppler ultrasonography and echocardiography: left ventricular ejection fraction (lvef≥55%); (4) fridericia calibrated qt interval (qtcf) for 18-lead ecg \<470 ms; 7. for female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. volunteer to join the study and sign the informed consent. exclusion criteria: 1. known allergic history of the drug components of this protocol; 2. previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma); 3. has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery; 4. stage iv (metastatic) breast cancer patients; 5. inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug; 6. serious heart disease or discomfort that cannot be treated; 7. suffering from mental illness or psychotropic substance abuse, unable to cooperate; 8. pregnant or lactating women; 9. patients with severe liver and kidney function diseases and blood system diseases; 10. those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; patients with poor compliance and refusal to cooperate with treatment; patients with severe high blood pressure, diabetes and other doctors deemed unsuitable for joining the study.