NCT05638594

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	320mg, qd
DRUG	Trastuzumab	8 mg/kg first dose, then 6 mg/kg，q3w
DRUG	Dalpiciclib	125mg , qd，d1-21, q4w
DRUG	Letrozole	2.5mg，qd
DRUG	Pertuzumab	840 mg first dose, then 420 mg, q3w
DRUG	Docetaxel	75 mg/m2, q3w
DRUG	Carboplatin	AUC 6, q3w
DRUG	Gonadotropin-releasing hormone agonist	Every 4 weeks for 5 cycles, premenopausal patients only

Timeline

• Start date: 2022-12-20
• Primary completion: 2025-12-10
• Completion: 2027-12-10
• First posted: 2022-12-06
• Last updated: 2023-03-20

Locations

1 site across 1 country: China