Clinical Study of Pyrotinib in Neoadjuvant Therapy of HR-positive and HER2-positive Breast Cancer

Inclusion Criteria:

1. Women aged 18-70 with breast cancer;
2. Pathologically confirmed unilateral invasive ductal carcinoma (with or without intraductal carcinoma components);
3. Proposed to receive neoadjuvant therapy;
4. Positive ER and/or PgR (defined as ≥10% positive immunohistochemical test);
5. HER2 positive (defined as IMMUNOHISTOchemical HER2 ++, or HER2 ++ and in situ hybridization (ISH) results in HER2 gene amplification);
6. There is no evidence of metastasis in clinical or imaging;
7. ECOG score 0 or 1;
8. White blood cell count ≥3.5×109/L, neutrophil count ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥90 g/L before neoadjuvant therapy;
9. Before neoadjuvant therapy, AST and ALT \< 1.5 times the upper limit of normal value, alkaline phosphatase \< 2.5 times the upper limit of normal value, total bilirubin \< 1.5 times the upper limit of normal value; Serum creatinine \< 1.5 times the upper limit of normal value;
10. LVEF≥55% on 2d echocardiography before neoadjuvant therapy;
11. Signed informed consent.

Exclusion Criteria:

1. Clinical or imaging suspicion of lateral breast malignancy has not been confirmed;
2. Prior malignancy (except basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer;
3. The patient has been enrolled in other clinical trials;
4. Patients suffering from serious systemic diseases and/or uncontrollable infections cannot be enrolled in the study;
5. Severe cardiovascular and cerebrovascular diseases (e.g., unstable angina pectoris, chronic heart failure, uncontrolled hypertension \> 150/90mmHg, myocardial infarction or cerebrovascular accident) within the first 6 months of randomization;
6. Have a history of blood system diseases, especially platelet-related diseases;
7. Patients with previous intestinal inflammation, intestinal dysfunction, severe diarrhea and constipation;
8. People who are known to be allergic to chemotherapy drugs, targeted drugs or TKI drugs;
9. Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment;
10. Pregnant and lactation women;
11. positive pregnancy test before drug use after joining the test;
12. Mental illness, cognitive impairment, inability to understand the test protocol and side effects, inability to complete the test protocol and follow-up workers (systematic evaluation is required before the trial is enrolled);
13. Persons without personal freedom and independent capacity for civil conduct.