Overview

Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Status:
Terminated

Trial end date:
2020-11-02

Target enrollment:

Participant gender:

Summary

This study is a Phase 1b open label, single arm, adaptive multi-centre trial of copanlisib in combination with trastuzumab emtansine (T-DM1) in pretreated locally advanced or metastatic HER2-positive breast cancer. Patients with unresectable locally advanced or metastatic HER2-positive breast cancer who previously received trastuzumab and a taxane, separately or in combination, will be treated with copanlisib (to the dose escalation scheme) plus trastuzumab emtansine 3.6mg/kg IV on day 1 of a 21-day cycle.

Phase:

Phase 1

Details

Lead Sponsor:

Cancer Trials Ireland

Treatments:

Ado-Trastuzumab Emtansine
Maytansine
Trastuzumab