Principal Investigator – Bruce Johnson, MD ( Bruce_Johnson@dfci.harvard.edu)
Overall Accrual: over 3,000 patients with metastatic breast cancer who have successful OncoPanel tests.
11-104/17-000 (Profile) is the umbrella protocol for clinical data, tissue collection and genomic testing of tumors across DFCI, BWH, and Boston’s Children’s Hospital. Patients have been consented since 2011. There have been different versions of the assay used since 2011. The Oncomap assay was used from 8/01/2011 through the end of September 2013 from DFCI (adult and pediatric), BWH (Adults) and consult patients referred from other hospitals to DFCI and BWH are included. Three versions of OncoPanel tests are included in the database: OncoPanel Version 1 (v1) data includes patients sequenced between 6/26/2013 and 8/6/2014. Oncopanel v1 includes an initial 275 cancer genes and 91 introns across 30 genes for rearrangement detection. Implemented on August 7 of 2014, Version 2 of OncoPanel expands on the initial version to include the exonic regions of an additional 25 genes associated with disease and drug response, intronic regions of an additional 4 genes, as well as other non-coding regions across several other genes. Version 3 of Oncopanel went live on October 4, 2016; Version 3.1 as of March 4, 2018.
All DFCI patients are approached at registration for consent to the protocol. The consent rate, however, has varied and overall within breast cancer patients has been less than 50 percent. The Breast Oncology Center has prioritized approach and consent for 11-104/17-000 in patients with metastatic breast cancer on the clinical floors. Oncomap/Oncopanel testing has been ordered primarily on patients with metastatic breast cancer and the consent rate for these patients is higher, based on targeted consent efforts in the breast oncology clinic for these patients. In addition, it is important to note that because of the targeted metastatic population, analyses examining disease-free survival and recurrence rates are not feasible in the breast cancer dataset.
There are some non-curated clinical data elements that can be linked to Oncomap/Oncopanel results available in OncDRS (for example, age, race, sex, chemotherapy ordered within EPIC), however, detailed curated clinical data, including ER, PR, and HER2 status, and any information from outside records, are not available through OncDRS for breast cancer patients. Other data sources outlined in this document will need to be used to obtain this type of clinical data and use of this data requires formal collaboration with Dr. Eric Winer, Dr. Nancy Lin, and Dr. Deborah Dillon, and approval by the Oncopanel Sub-committee of the DF/HCC Breast Users Committee.