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

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.

Trial Details

NCT ID

NCT05638594

Phase

PHASE2

Sponsor

Shengjing Hospital

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

Pyrotinib
Trastuzumab
Dalpiciclib
Letrozole
Pertuzumab
Docetaxel

Locations (sample)

Shenyang, Liaoning, China|41.79222,123.43278

Key Eligibility Criteria

Female patients aged 18 -75 ;
Willing to receive LHRH agonist therapy (premenopausal patients only);
All patients were histopathologically confirmed to be estrogen receptor (ER) -positive and HER2-positive.
Treatment-naïve stage II-III patients with tumor stage meeting AJCC version 8 criteria;

For full eligibility, visit ClinicalTrials.gov.

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