Abstract P2-21-01: Feasibility of a multidisciplinary diagnostic breast research biopsy project

Abstract Background: The comprehensive analysis of clinically annotated tissue specimens from those with either benign, high risk or malignant breast findings is critical to improve the understanding of breast cancer biology and treatment. Through a multidisciplinary team approach, we designed a protocol to allow a breast research biopsy to be collected with informed patient consent concurrent with the diagnostic biopsy at our institution. Here we describe the feasibility of the project. Methods: IRB approval was obtained for the prospective collection and storage of clinically-annotated specimens, including breast biopsy cores, excess surgical tissue from breast surgery, and optional blood collection. Potential participants are identified through the list of scheduled breast biopsies at the Massachusetts General Hospital breast imaging center. Eligible patients are those ≥ age 18 undergoing a clinical breast biopsy. Research consent is obtained in the procedure room immediately following the clinical consent process and prior to the clinical biopsy. Following completion of standard clinical biopsy workflow, two research core biopsy specimens are obtained with a core biopsy needle ranging from 9 to 18 gauge. The first research specimen is flash frozen and stored on dry ice to preserve high molecular weight DNA and RNA. The second sample is cryopreserved in DMSO or a related agent to allow viable cell recovery. All consented patients are entered into a prospective database in REDCap. Medical records of the participating patients are reviewed periodically to collect data on patient demographics, tumor characteristics, and long-term outcomes. Results: From 1/17/19 through 6/28/19, 144 patients were approached. 77.8% of patients consented, resulting in 96 lesions being biopsied for research. Of these, 45.8% were invasive carcinoma, 3.1% were DCIS, 6.1% were high risk lesions, and 44.8% were benign. Among the invasive breast cancers, 78.6% were hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), 9.5% were HER2+, and 11.9% were triple negative. Conclusion: We demonstrated that an upfront breast research biopsy program in patients presenting for initial diagnostic breast biopsy is feasible, with high rates of patient participation. Overall, 77.8% of approached subjects agreed to a concurrent research breast biopsy at the time of diagnostic biopsy. This approach may provide a high yield mechanism to generate a rich tissue repository with low cost and marginal additional time commitment by patient and providers that can support novel, cross-disciplinary research. A number of collaborative research projects are planned. Citation Format: Kassidy Beyerlin, Christine Edmonds, Siang Boon Koh, Veerle Bossuyt, Annie Ma, Rachel Jimenez, Michelle Specht, Barbara L Smith, Brian Dontchos, Dennis Sgroi, Steven J Isakoff, Constance Lehman, Leif W Ellisen, Laura M Spring. Feasibility of a multidisciplinary diagnostic breast research biopsy project [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-21-01.