Clinical Trial

Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer

Recruiting Phase 2
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Record status
This record was last updated March 20, 2023 (before its estimated December 10, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-12-02.
Status change: Not Yet Recruiting → Recruiting 2023-03-16
Trial Details
NCT Number NCT05638594
Lead Sponsor Shengjing Hospital
Conditions Breast Cancer
Enrollment 236 participants
Start Date 2022-12-20
Primary Completion 2025-12-10 (estimated)
Study Completion 2027-12-10 (estimated)
Updated on ClinicalTrials.gov 2023-03-20