NCT01565200 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1 (ZEPHIR) (NCT01565200)

Trial Description
Ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.), which is a highly innovative but also expensive antiHER2 agent consisting in the coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine derivate) has shown an encouraging antitumor activity evaluated by Recist criteria (35% objective response rate, 44% stable disease, 18% progressive disease) in patients with advanced HER2 positive Breast Cancer pretreated with several cytotoxic drugs, trastuzumab and lapatinib.

Rationale I :For TDM1 to be active, the presence of an intact HER2 receptor is “key” since the internalization of the cytotoxic moiety depends on the binding of trastuzumab to the external domain of HER2.

The zirconium 89 labelled trastuzumab PET/CT (or HER2 immunoPET/CT) is a non invasive test which shows promise in measuring HER2 expression (extracellular domain) for the entire disease burden and which could identify non responding patients prior to TDM1 administration.

Rationale II: As for many such agents, it is desirable to identify early on (here with the use of FDG-PET/CT) which patients are unlikely to benefit from the therapy.

This trial is sponsored by Jules Bordet Institute. [1]

Study Data

  • Condition:  HER-2 Positive Breast Cancer
  • Interventions:
    • Drugs used in this trial
    • Procedure: 89Zr-trastuzumab
  • Phase: II
  • Estimated Enrollment: 105
  • Start: April 2012
  • Estimated Completion: November 2017
  • Last verified: January 2015

Study Schematic

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Last Editorial review: July 28, 2015
Information based on (NIH/NCI) and other sources.

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