RecruitingPhase 2NCT05638594

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


Sponsor

Shengjing Hospital

Enrollment

236 participants

Start Date

Dec 20, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two pre-surgery (neoadjuvant) treatment regimens in women with hormone receptor–positive AND HER2-positive breast cancer. One regimen uses targeted oral drugs (pyrotinib, trastuzumab, dalpiciclib, letrozole); the other uses standard IV chemotherapy plus dual HER2 blockade. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have stage II or III breast cancer that is both estrogen receptor–positive (ER+) and HER2-positive - You have not yet received any cancer treatment - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have received any prior cancer treatment - Your cancer is stage I or IV - You are premenopausal and unwilling to receive hormone suppression therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPyrotinib

320mg, qd

DRUGTrastuzumab

8 mg/kg first dose, then 6 mg/kg,q3w

DRUGDalpiciclib

125mg , qd,d1-21, q4w

DRUGLetrozole

2.5mg,qd

DRUGPertuzumab

840 mg first dose, then 420 mg, q3w

DRUGDocetaxel

75 mg/m2, q3w

DRUGCarboplatin

AUC 6, q3w

DRUGGonadotropin-releasing hormone agonist

Every 4 weeks for 5 cycles, premenopausal patients only


Locations(1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

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NCT05638594


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