Clinical Validation

Cross-Stratification and Differential Risk by Breast Cancer Index and Recurrence Score in Women with Hormone Receptor–Positive Lymph Node–Negative Early-Stage Breast Cancer

Published: October 15, 2016

Author(s): Ivana Sestak, Yi Zhang, Brock E. Schroeder, Catherine A. Schnabel, Mitch Dowsett, Jack Cuzick, and Dennis Sgroi

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Prospective assessment of the decision-making impact of the Breast Cancer Index in recommending extended adjuvant endocrine therapy for patients with early-stage ER-positive breast cancer

Published: December 7, 2015

Author(s): Sanft T, Aktas B, Schroeder B, Bossuyt V, DiGiovanna M, Abu-Khalaf M, Chung G, Silber A, Hofstatter E, Mougalian S, Epstein L, Hatzis C, Schnabel C, Pusztai L.

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Prediction of late distant recurrence in estrogen receptor positive breast cancer patients: prospective comparison of the Breast Cancer Index (BCI), Oncotype DX recurrence score, and IHC4 in TransATAC

Published: September 1, 2013

Author(s): Dennis C. Sgroi, M.D. (Full Professor), Ivana Sestak, Ph.D., Jack Cuzick, Ph.D. (Full Professor), Yi Zhang, Ph.D., Catherine A. Schnabel, Ph.D., Brock Schroeder, Ph.D., Mark G. Erlander, Ph.D., Anita Dunbier, Ph.D., Kally Sidhu, BSc,5 Elena Lopez-Knowles, Ph.D., Paul E. Goss, M.D., (Full Professor), and Mitch Dowsett, Ph.D., (Full Professor)

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Breast Cancer Index Identifies Early-Stage Estrogen Receptor–Positive Breast Cancer Patients at Risk for Early- and Late-Distant Recurrence

Published: August 1, 2013

Author(s): Yi Zhang, Catherine A. Schnabel1, Brock E. Schroeder, Piiha-Lotta Jerevall, Rachel C. Jankowitz, Tommy Fornander, Olle Stål, Adam M. Brufsky, Dennis Sgroi, and Mark G. Erlander

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Prediction of Late Disease Recurrence and Extended Adjuvant Letrozole Benefit by the HOXB13/IL17BR Biomarker

Published: June 28, 2013

Author(s): Dennis C. Sgroi, Erin Carney, Elizabeth Zarrella, Lauren Steffel, Shemeica N. Binns, Dianne M. Finkelstein, Jackie Szymonifka, Atul K. Bhan, Lois E. Shepherd, Yi Zhang, Catherine A. Schnabel, Mark G. Erlander, James N. Ingle, Peggy Porter, Hyman B. Muss, Katherine I. Pritchard, Dongsheng Tu, David L. Rimm and Paul E. Goss

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Health Economics

Health Economic Analysis of Breast Cancer Index in Patients With ER+, LN– Breast Cancer

Published: September 10, 2014

Author(s): Gary Gustavsen, MS; Brock Schroeder, PhD; Patrick Kennedy, BE; Kristin Ciriello Pothier, MS; Mark G. Erlander, PhD; Catherine A. Schnabel, PhD; and Haythem Ali, MD

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Predictive testing for selection of patients for extended endocrine therapy: clinical utilization of Breast Cancer Index (BCI) in early-stage, ER+, LN- Breast cancer.

Author(s): Stephen C. Malamud, MD, Brock E. Schroeder, PhD, Theresa N. Operaña, PhD, Catherine A. Schnabel, PhD

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Prognostic Impact of Genomic Risk Stratification with Breast Cancer Index in Patients with Clinically Low Risk, Hormone Receptor-positive, Node-Negative, T1 Breast Cancer.

Author(s): Brock E. Schroeder, Yi Zhang, Olle Stal, Tommy Fornander, Adam Brufsky, Dennis C. Sgroi, Catherine A. Schnabel

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A Multi-institutional, Prospective Study of Incorporating the Genomic Platform Breast Cancer Index as a Tool for Decision-making Regarding Extension of Adjuvant Endocrine Therapy.

Author(s): Tara Sanft, Alyssa Berkowitz, Brock Schroeder, Christos Hatzis, Catherine A. Schnabel, Bilge Aktas, Adam Brufsky, Lajos Pusztai, G.J. van Londen

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Correlation of Breast Cancer Index (BCI) Risk Classification with Tumor Grade and Ki-67 in a Large Series of Patients with Early-stage, ER+ Breast Cancer.

Author(s): Hatem Soliman, Brock E. Schroeder, Yi Zhang, Anthony M. Magliocco, Catherine A. Schnabel

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Impact of Treatment History on Prognostic Ability of Breast Cancer Index (BCI): Subset Analysis From a Validation Study of Patients with Hormone Receptor-Positive (HR+) Breast Cancer with 1-3 Positive Nodes.

Author(s): Yi Zhang, Piiha-Lotta Jerevall, Brock E. Schroeder, Amy Ly, Hannah Nolan, Catherine A. Schnabel, Dennis Sgroi

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Pathway correlates in ER-positive primary breast tumors with high-HOXB13 expression.

Author(s): Catherine A. Schnabel, Yi Zhang; Biotheranostics, Inc.

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Clinical impact of differential risk stratification by breast cancer index (BCI) versus recurrence score (RS) in HR+ early-stage breast cancer: A TransATAC study.

Author(s): Ivana Sestak, Yi Zhang, Catherine A. Schnabel, Brock Schroeder, Mark Erlander, Paul E. Goss, Jack M. Cuzick, Mitchell Dowsett, Dennis Sgroi; Queen Mary, University of London, London, United Kingdom; Biotheranostics, Inc., San Diego, CA; Trovagene, San Diego, CA; Massachusetts General Hospital Cancer Center, Boston, MA; Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, London, United Kingdom; The Royal Marsden NHS Foundation Trust, London, United Kingdom; Massachusetts General Hospital, The Avon Foundation, Boston, MA

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Prediction of benefit from endocrine therapy in ER+ early stage breast cancer: Correlative studies of the breast cancer index HoxB13/IL17BR (H/I) ratio, ER, PR, and HER2 expression in the randomized Stockholm trial

Author(s): Zhang Y, Schroeder BE, Jerevall Jannok P-L, Fornander T, Stal O, Schnabel CA, Sgroi DC. Biotheranostics, Inc, San Diego, CA; Massachusetts General Hospital, Boston, MA; Karolinska University Hospital, Stockholm, Sweden; Linköping University, Linköping, Sweden

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Integration of breast cancer index (BCI) with clinicopathological factors for prediction of distant recurrence in ER+ breast cancer

Author(s): Sestak I, Zhang Y, Schroeder BE, Goss PE, Dowsett M, Sgroi DC, Schnabel CA, Cuzick J. Centre for Cancer Prevention, Queen Mary University, London, United Kingdom; Biotheranostics, Inc, San Diego, CA; Massachusetts General Hospital, Boston, MA; Royal Marsden Hospital, London, United Kingdom

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Prognostic significance of breast cancer index (BCI) in node-positive hormone receptor positive early breast cancer: NCIC CTG MA.14

Author(s): Sgroi D, Goss P, Chapman J-A, Richardson E, Binns S, Zhang Y, Schnabel C, Erlander M, Pritchard K, Han L, Sheperd L, Pollack M. Massachusetts General Hospital, Boston, MA; Queens University, Kingston, ON, Canada; Biotheranostics, Inc, San Diego, CA; Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada; McGill University, Montreal, QC, Canada

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Breast Cancer Index Intended Use and Limitations

The Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test is intended for use in patients diagnosed with estrogen receptor-positive (ER+), lymph node-negative (LN-) or lymph node positive (LN+; with 1-3 positive nodes) early-stage, invasive breast cancer, who are distant recurrence-free. BCI provides: 1) a quantitative assessment of the likelihood of both late (post-5 years) and overall (0-10 year) distant recurrence following an initial 5 years of endocrine therapy (LN- patients) or 5 years of endocrine therapy plus adjuvant chemotherapy (LN+ patients), and 2) prediction of likelihood of benefit from extended (>5 year) endocrine therapy. BCI results are adjunctive to the ordering physician’s workup; treatment decisions require correlation with all other clinical findings.

This test was developed and its performance characteristics determined by Biotheranostics, Inc. lt has not been cleared or approved by the U.S. Food and Drug Administration. This test is used for clinical purposes. lt should not be regarded as investigational or for research. How this information is used to guide patient care is the responsibility of the physician. Biotheranostics is certified under the Clinical Laboratory lmprovement Amendments of 1988 to perform high complexity clinical laboratory testing.