Investigating the Utility of comprehensive genomic Profiling for patients with newly diagnosed breast cancer.

Tumor Biology
Session Type and Session Title: 
Poster Session, Tumor Biology
Abstract Number: 


Poster Board Number: 
Board #312b
J Clin Oncol 34, 2016 (suppl; abstr TPS11617)
Casey B. Williams, Robert Goldberg, Kirstin Anne Williams, Pradip De, Jessica Klein, Nandini Dey, Brandon Michael Young, Kimberly C. Banks, Christine Elaine Lee, Richard Burnham Lanman, Siraj Mahamed Ali, Jeffrey S. Ross, Vincent A. Miller, Benjamin Maurice Solomon, Amy K. Krie, Brian Leyland-Jones; Avera Cancer Institute, Sioux Falls, SD; CMPI, New York, NY; Guardant Health, Inc., Redwood City, CA; Guardant Health, Redwood City, CA; Foundation Medicine, Inc., Cambridge, MA; Albany Medical College, Albany, NY

Abstract Disclosures


Background: Studies of neoadjuvant chemotherapy in Stage II and III breast cancer patients suggest that some have significant benefit from chemotherapy while others appear to derive much less value. Since breast cancer is a genetically and clinically heterogeneous disease, the ability to identify markers that predict early responders to standard chemotherapy and long-term survival would markedly improve the breast cancer treatment paradigm. Rational matching of approved and investigational drugs with cohorts of patients whose disease characteristics suggest they might benefit from this “personalized” therapy requires an understanding of the fundamental regulatory pathways that control breast cancer biology as well as development of validated assay methods to reproducibly identify tissue or serum markers that predict response. We will report the early results of a study to evaluate the utility of comprehensive genomic profiling (including cell-free circulating DNA (cfDNA) next generation sequencing (NGS)) to target agents to the biology of specific signatures and to rapidly assess response to neoadjuvant chemotherapy, with confirmation of response at the time of surgical excision. We hypothesize that genomic and proteomic profiling of tumor samples will identify aberrations that are linked to targeted therapies and that can be combined in treating patients. We also believe that such personalized treatment will be of significantly higher value to the patient compared to a standard of care or population based pathways. Methods: All newly diagnosed breast cancer patients enrolled to the protocol NCT02470715 from June 2014 to April 2016 and eligible for neoadjuvant therapy will be evaluated for two primary outcomes: 1) Aggregate results of the multiplatform comprehensive genomic profiling utilized in the trial and any subsequent therapy recommendations if applicable 2) Compare the outcomes and cost of the therapy for patients that received all of the recommended treatment, at least one, but not all of the recommended drugs, or only standard of care. Clinical trial information: NCT02470715