Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
A Randomized Controlled, Open-label, Multicenter Clinical Study of Pyrotinib Maleate Combined With Trastuzumab,Dalpiciclib, and Letrozole Versus Trastuzumab Combined With Pertuzumab, Docetaxel, and Carboplatin as Neoadjuvant Therapy for Stage II-III HR +/HER2 + Breast Cancer
Shengjing Hospital
236 participants
Dec 20, 2022
INTERVENTIONAL
Conditions
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
Plain Language Summary
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Interventions
320mg, qd
8 mg/kg first dose, then 6 mg/kg,q3w
125mg , qd,d1-21, q4w
2.5mg,qd
840 mg first dose, then 420 mg, q3w
75 mg/m2, q3w
AUC 6, q3w
Every 4 weeks for 5 cycles, premenopausal patients only
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05638594