HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
T-DM1 , 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