Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive，HR-Positive Metastatic Breast Cancer

Exclusion Criteria

• •1. Patients who have not received trastuzumab, chemotherapy or endocrine therapy before;
• •2. Patients with visceral crisis;
• •3. Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption;
• •4. Patients with malignant serous effusion which cannot be controlled by drainage or other methods;
• •5. Less than 4 weeks from the last treatment in the last clinical trial;
• •6. Receiving any other antitumor therapy;
• •7. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent;
• •8. Patients with serious heart disease;
• •9. Allergy to Pyrotinib; the history of immunodeficiency；
• •10. Known history of neurological or psychiatric disease, including epilepsy or dementia;
• •11. Patients during pregnancy or lactation, patients with childbearing potential tested positive in a baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial;
• •12. Evidence of significant medical illness that will substantially increase the risk of the participation or completion of the study in the investigator's judgment. Examples included, but not limited to, hypertension, severe diabetes, etc;