Journal
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE
Volume 94, Issue 11, Pages 855-857Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/jnci/94.11.855
Keywords
-
Categories
Funding
- NCI NIH HHS [CA63849, CA63848, CA63826, CA60276, CA52352, CA37417, CA37404, CA35415, CA35272, CA35269, CA35195, CA35103, CA35101, CA25224, CA15083, U10CA25224-21] Funding Source: Medline
Ask authors/readers for more resources
The efficacy of trastuzumab for metastases coupled with the relatively poor prognosis of patients with nodepositive, HER2-positive breast cancer has led to the evaluation of trastuzumab as an adjuvant therapy. A prospective, randomized, three-arm, phase III trial is being conducted by the Breast Intergroup (N9831) for women with primary, operable, histologically confirmed, node-positive breast carcinoma that strongly overexpresses (3+) HER2 protein and/or displays HER2/neu gene amplification, as determined by local laboratory testing. The protocol requires confirmatory central testing of HER2 status using the HercepTest(TM) immunohistochemistry and the Vysis PathVysion(TM) fluorescence in situ hybridization (FISH) assays. Tumor specimens from the first 119 patients enrolled in N9831 were centrally tested; 74% were found to be HercepTest(TM) 3+ and 66% were found to have HER2 gene amplification. Only six of nine (67%) of the specimens submitted by local laboratories as FISH positive could be confirmed by central assays. The concordance for central HercepTest(TM) and central FISH assays was 92%. The poor concordance (74%) between local and central testing for HER2 status has led to modifications in the eligibility criteria for N9831.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available