Title: Single arm, open label, signal seeking, phase IIa trial of the activity of Trastuzumab emtansine (T-DM1) in patients with tumours harbouring HER2 amplifications or mutations

Trial Summary:

The aim of these MoST substudies is to assess the clinical value of HER2 inhibition using T-DM1 in advanced cancer patients with tumours with (i) HER2 mutations and (ii) HER2 amplification.

Supported By:

 

Eligibility:

Participants will be enrolled in the MoST program for molecular screening and eligible for this study if their tumour demonstrates an activating HER2 mutation or HER2 amplification.

Solid tumours:

Group 1: activating HER2 mutation; Group 2: HER2 amplification in the absence of a HER2 mutation – Breast and gastric cancers will not be eligible for group 2.

Newly diagnosed metastatic, non-squamous NSC Lung Cancer (ASPiRATION study):

Group 3: activating HER2 mutation; Group 4: HER2 amplification in the absence of a HER2 mutation

Registration ID:

ACTRN12619001265167

Participation:

National

Status:

Recruiting

Activation Date:

30/09/2020

Chairs:

Professor David Thomas

Contact:

most.study@sydney.edu.au