NSABP Biospecimen Discovery Project
This study will be conducted at select NSABP sites where investigators are willing to give
paclitaxel plus trastuzumab before the anthracycline-based component of neoadjuvant therapy
as a pilot for a comprehensive 'omics approach using next generation sequencing and protein
expression and post-translational modification analysis using mass spectrometry (MS) based
and Reverse Phase Protein Array-based proteomics. Tumor samples will be obtained at
baseline and 48 to 72 hours after initial drug treatment to study variation in the
biological responses to these agents. The study of tumors both before and early after the
first treatment probes the biological responses to treatment and is rich source of
Observational Model: Cohort, Time Perspective: Prospective
Measure variation in biologic response by comprehensive tumor 'omics profiling in patients receiving an upfront regimen containing paclitaxel plus trastuzumab
blood and tissue specimens will be collected at the time of diagnosis; prior to treatment; 48 and 72 hours following first dose of treatment; and following surgery, if tumor remains.
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Institutional Review Board