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RECRUITING
NCT05638594
PHASE2

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

View on ClinicalTrials.gov

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

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

Locations (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China