Overview

Neoadjuvant Study of Dalpiciclib in Combination With Letrozole and Trastuzumab Plus Pyrotinib in Early ER+ HER2+ Breast Cancer

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:

Participant gender:

Summary

This is a phase II open-label, multicenter trial. The study assesses the treatment of patients with ER-positive /HER2 positive early breast cancer with neoadjuvant Dalpiciclib in Combination With Letrozole and Trastuzumab plus pyrotinib. Patients were treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) and oral pyrotinib (400 mg po QD, Q3W) for six cycles plus oral Dalpiciclib (150 mg QD x 21 Q4W) and oral letrozole (2.5 mg po QD for 20 weeks). The primary endpoints was pathological complete response.

Phase:

Phase 2

Details

Lead Sponsor:

First Affiliated Hospital of Zhejiang University

Treatments:

Letrozole
Trastuzumab