Trials
correlating activity of Herceptin with HER2 assays
Interview
with Neil Love, MD from Breast Cancer Update for Medical Oncologists,
Program 3 2000
Play
Audio Below:
Edith
Perez will be leading for the North Central Cancer Treatment Group, where
patients with tumors that over-express HER2 at the 1+ and 2+ level will
be randomized to receive a chemotherapy regimen of Taxol and carboplatin
with or without Herceptin to gauge the potential role of
adding Herceptin in that group of patients. And similarly, Im leading
a trial for the CALGB CALGB 9840 which is randomizing patients
to Taxol, either by conventional schedule or bi-weekly one-hour or dose
dense scheduling. And for those patients who are HER2 neu over-expressing
clearly, they will all receive Herceptin with one or the other Taxol schedule.
For those patients who by community based assay are HER2-negative
those patients will be randomized not only to Taxol schedule, but to get
Herceptin or not. We are planning a correlative science component of that
trial, where after we know the community-based pathologists assay we will,
in a centralized lab, be examining these tumor tissues by other immunohistochemical
tests also collecting serum where possible and measuring circulating
HER2 extracellular domain, and finally, in work that will be done by Lynn
Dressler for the CALGB examining gene amplification using the Visis path
vision assay.