clinical trial · NCT07179939
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
Fudan University·phase2·not yet recruiting·n = 288
HER2-positive Breast CancerTrastuzumab rezetecanPyrotinibDalpiciclibTrastuzumabET: Letrozole/ Anastrozole/ Exemestane/ Fulvestrant/ Leuprorelin/ Goserelin.
brief summary
This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses following trastuzumab rezetecan (T-DXh, SHR-A1811) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.
started
Sep 10, 2025
primary completion
Dec 30, 2030
completion
Dec 30, 2031
last updated
Sep 18, 2025
official title
A Multicenter, Open-Label, Phase II Trial of Exploring the Maintenance of Trastuzumab Plus Pyrotinib or Trastuzumab Plus Dalpiciclib and Endocrine Therapy Based on HR Status Following Trastuzumab Rezetecan as Induction Treatment for HER2 Positive Unresectable Locally Recurrent or Metastatic Breast Cancer
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol