The LabSolutions Registry is a proof of principle registry to fine tune their germline genetic test to ordering physician’s preferences including genes, appearance of report, and content. Once the pilot is completed and test/report refined, there may be an opportunity for a larger all comers registry.
Title: Universal Breast Cancer Genetic Testing Registry
Summary: Expanded panel germline genetic testing for all breast cancer patients unrelated to guidelines. Primary endpoint is pathogenic mutation rate: Overall, Patients meeting NCCN guidelines, Patients NOT meeting NCCN guidelines. Secondary endpoint is analysis of pathogenic mutation by age, tumor subtype, associated cancers.
Summary: Genomic analysis of breast cancer core biopsy before neo-adjuvant chemotherapy for loco-regionally advanced Her2+, tirple negative and luminal B subtypes. Standard NCCN recognized regimes will be administered and pathology at definitive surgery will be correlated to the biomarker analysis and regime given. Residual cancer in non-complete responders will be analyzed (if adequate tumor volume) and potentially used for adjuvant systemic therapy.
Title: Neo-Adjuvant Breast Cancer Liquid Biopsy Registry
Summary: Genomic analysis of blood from breast cancer patients before neo-adjuvant chemotherapy for loco-regionally advanced Her2+, tirple negative and luminal B subtypes. Standard NCCN recognized regimes will be administered and pathology at definitive surgery will be correlated to the biomarker analysis and regime given. Blood will again be analyzed prior to surgery to determine if there is still circulating DNA +/- circulating cells. this will be correlated to surgical pathology to determine if the blood test could be a surrogate for surgery/pathology. Blood will also be analyzed post definitive surgery for 1) possible targeting of a residual biomarker for adjuvant systemic therapy and 2) need for radiation therapy. Blood will be analyzed post radiation therapy to correlate with 1) effectiveness of radiation therapy and 2) potential need for adjuvant systemic therapy. Lastly, blood will be analyzed at 1 and 3 years to look for recurrence and correlate with standard imaging.