drugset / Trial / NCT05800756

Pyrotinib Combined With Trastuzumab,Dalpiciclib and Letrozole for HR+/HER2+ Breast Cancer

NCT05800756

NaSingle-groupOpen-labelTreatment

Summary

In this single arm, open label, phase 2 trial, operable patients with stage II-III HR+/HER2+ breast cancer will be enrolled and receive two cycles of pyrotinib combined with trastuzumab, dalpiciclib and letrozole. Imaging evaluation was performed two weeks later, and patients who achieved CR or PR were continued with the original regimen for 4 cycles. Subjects who did not achieve PR switched to regimen and received 4 cycles of pyrotinib combined with trastuzumab plus chemotherapy. This study aims to assessed the biological effects and safety of pyrotinib combined with trastuzumab, dalpiciclib and letrozole for HR+/HER2+ breast cancer in the neoadjuvant setting.

Timeline

Start
2022-08-04
Primary completion
2024-05-31
Completion
2025-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule 125 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Pyrotinib Small molecule 320 mg Oral
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications