pyrotinib combined with trastuzumab, dalpiciclib, letrozole versus tcbhp (trastuzumab plus pertuzumab with docetaxel and carboplatin) as neoadjuvant treatment in hr +/her2 + breast cancer

Conditions: Breast Cancer

Summary: this is an investigator-initiated randomized controlled, open-label, multicenter, prospective phase 2 clinical study. patients with stage ii-iii hr +/her2 + breast cancer were randomly divided into two groups at a ratio of 1:1. the experimental group received pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group received trastuzumab combined with pertuzumab, docetaxel and carboplatin. the main study objective was to evaluate the efficacy and safety of neoadjuvant therapy for hr +/her2 + breast cancer in the two groups.


Eligibility criteria:
inclusion criteria: 1. female patients aged 18 -75 ; 2. willing to receive lhrh agonist therapy (premenopausal patients only); 3. all patients were histopathologically confirmed to be estrogen receptor (er) -positive and her2-positive. 4. treatment-naïve stage ii-iii patients with tumor stage meeting ajcc version 8 criteria; 5. ecog score 0-1; 6. organ function level must meet the following requirements: (1) bone marrow function • anc ≥ 1.5 x 109/l ; • plt ≥ 100 × 109/l • hb ≥ 90 g/l ; (2) hepatic and renal function • tbil ≤ 1.5 × uln; • al and ast ≤ 3 × uln (alt and ast ≤ 5 × uln in patients with liver metastases); • bun and cr ≤ 1.5 × uln and creatinine clearance ≥ 50 ml/min; (cockcroft-gault formula) (3) echocardiography: lvef ≥ 50%; (4) 12-lead ecg: qt interval ≤ 480 ms; 7. able to undergo needle biopsy; 8. voluntarily join this study to sign informed consent, have good compliance and willing to cooperate with follow-up. exclusion criteria: 1. received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 2. received any other anti-tumor therapy at the same time; 3. bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. stage iv breast cancer; 5. breast cancer without histopathological diagnosis; 6. other malignant tumors in the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ; 7. severe heart, liver and kidney and other vital organ dysfunction; 8. inability to swallow, chronic diarrhea and intestinal obstruction, there are a variety of factors affecting drug administration and absorption; 9. participated in other drug clinical trials within 4 weeks before enrollment; 10. known history of hypersensitivity to the drug components of this protocol; history of immunodeficiency, including positive hiv test, hcv, active viral hepatitis b or other acquired, congenital immunodeficiency diseases, or history of organ transplantation; 11. had any cardiac disease, including: (1) cardiac arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be inappropriate for participation in this trial; 12. female patients who are pregnant or lactating, female patients of childbearing potential with a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 13. according to the investigator 's judgment, there are concomitant diseases that seriously jeopardize the patient' s safety or affect the patient 's completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.); 14. had a documented history of neurological or psychiatric disorders, including epilepsy or dementia.any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.