drugset / Trial / NCT07189884

Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy

NCT07189884

Phase 1/2 Not yet recruiting 33 enrolled The First Affiliated Hospital of Xiamen University
NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to evaluate the efficacy of this regimen in HR+HER2 low expression breast cancer. Imaging evaluation was performed according to RECIST 1.1 criteria, and tumor imaging evaluation was performed by the participating center. The pathological evaluation after surgery of neoadjuvant patients was the pCR assessed by the pathologist of the participating center.

Timeline

Start
2025-09-23
Primary completion
2026-06-30
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule 125 mg Oral
Subject Pyrotinib Small molecule 320 mg Oral

Indications