Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy

Exclusion Criteria

• •1. Patients who have previously used ADCs to treat advanced breast cancer
• •2. Symptomatic patients with brain metastases
• •3. Control unstable pleural effusion and ascites patients
• •5. Active infection requiring systemic treatment
• •6. Gastrointestinal dysfunction or disease that may seriously affect the absorption of the study drug (such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) or severely impair the ability to swallow capsules/tablets
• •7. Known history of myelodysplastic syndrome or acute myeloid leukemia
• •8. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 28 days
• •9. Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months
• •10. History of acute coronary syndrome (including myocardial infarction, unstable angina, coronary artery, arterial bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 6 years
• •11. Symptomatic congestive heart failure (New York Heart Association III-IV) or cardiomyopathy with left ventricular ejection fraction (LVEF) \<50%
• •12. Clinically significant ventricular arrhythmia (sustained tachycardia/ventricular fibrillation) or high-grade AV block (eg, bifascicular block, Mobitz type II, and third-degree AV block), unless fitted pacemaker
• •13. Any concurrent severe and/or uncontrolled medical conditions that, in the judgment of the investigator, would result in unacceptable safety risks, prohibit subjects from participating in clinical studies, or affect protocol compliance