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Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
Sponsor: Shengjing Hospital
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2022-12-20
Completion Date
2027-12-10
Last Updated
2023-03-20
Healthy Volunteers
No
Conditions
Interventions
Pyrotinib
320mg, qd
Trastuzumab
8 mg/kg first dose, then 6 mg/kg,q3w
Dalpiciclib
125mg , qd,d1-21, q4w
Letrozole
2.5mg,qd
Pertuzumab
840 mg first dose, then 420 mg, q3w
Docetaxel
75 mg/m2, q3w
Carboplatin
AUC 6, q3w
Gonadotropin-releasing hormone agonist
Every 4 weeks for 5 cycles, premenopausal patients only
Locations (1)
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China