Clinical Study of Pyrotinib in Neoadjuvant Therapy of HR-positive and HER2-positive Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring HR+/HER2+ Breast cancer, Neoadjuvant therapy, pyrotinib
Eligibility Criteria
Inclusion Criteria:
- Women aged 18-70 with breast cancer;
- Pathologically confirmed unilateral invasive ductal carcinoma (with or without intraductal carcinoma components);
- Proposed to receive neoadjuvant therapy;
- Positive ER and/or PgR (defined as ≥10% positive immunohistochemical test);
- HER2 positive (defined as IMMUNOHISTOchemical HER2 ++, or HER2 ++ and in situ hybridization (ISH) results in HER2 gene amplification);
- There is no evidence of metastasis in clinical or imaging;
- ECOG score 0 or 1;
- 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;
- 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;
- LVEF≥55% on 2d echocardiography before neoadjuvant therapy;
- Signed informed consent.
Exclusion Criteria:
- Clinical or imaging suspicion of lateral breast malignancy has not been confirmed;
- Prior malignancy (except basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer;
- The patient has been enrolled in other clinical trials;
- Patients suffering from serious systemic diseases and/or uncontrollable infections cannot be enrolled in the study;
- 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;
- Have a history of blood system diseases, especially platelet-related diseases;
- Patients with previous intestinal inflammation, intestinal dysfunction, severe diarrhea and constipation;
- People who are known to be allergic to chemotherapy drugs, targeted drugs or TKI drugs;
- Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment;
- Pregnant and lactation women;
- positive pregnancy test before drug use after joining the test;
- 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);
- Persons without personal freedom and independent capacity for civil conduct.
Sites / Locations
- the First Affiliated Hospital of Nanjing Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
TCbHPy*6
TCbHP*6
Pyrotinib combined with docetaxel, carboplatin and trastuzumab for 6 cycles (Every three weeks). T (Docetaxel 100 mg/m2, d1) C (Carboplatin, AUC 6, D1) H (Trastuzumab, 8 mg/kg for the first dose, 6 mg/kg for the rest, D1) Py (pyrotinib 400mg, qD, D1-21)
Pertuzumab combined with docetaxel, carboplatin and trastuzumab for 6 cycles (Every three weeks). T (Docetaxel 100 mg/m2, d1) C (Carboplatin, AUC 6, D1) H (Trastuzumab, 8 mg/kg for the first dose, 6 mg/kg for the rest, D1) P (Pertuzumab, 840mg for the first dose, 420mg for the rest, D1))