• Study Assesses Prognostic Value of BCI Testing and Its Potential in Supporting De-escalation of Primary Adjuvant Endocrine Therapy

MARLBOROUGH, Mass. / Dec 09, 2024 / Business Wire / Four new studies regarding the Breast Cancer Index (BCI) test will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS). Among these studies, initial data will be premiered investigating the potential role of the BCI test to identify postmenopausal women with hormone-receptor positive (HR+), early-stage, node-negative disease who are at minimal risk of experiencing a distant recurrence. Full results will be shared during Poster Session 1 on December 11, 2024, at 12:30 p.m. CT [#P1-09-13].

“Given challenges with tolerability of primary adjuvant endocrine therapy and high rates of patients discontinuing treatment, understanding which patients may have minimal risk of distant recurrence could support de-escalation of endocrine therapy prior to the five-year mark for some patients with HR+, early-stage breast cancer,” said Gerrit-Jan Liefers, MD, Ph.D., Surgeon at Leiden University Medical Centre and Primary Investigator of the study. “This may help care teams provide a more personalized approach to management of women struggling with the side effects of primary adjuvant endocrine therapy.”

The BCI test has previously been established as a predictive biomarker for the likelihood of benefit from extended endocrine therapy. It is identified by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) and the ASCO^® Clinical Practice Guideline as the only test to predict which women with HR+, early-stage breast cancer are likely to benefit from continuation of endocrine therapy beyond five years.^1,2

In this new investigational study, an adjusted Breast Cancer Index prognostic model with an additional cut point was defined identifying a “minimal risk” group with a 10-year distant recurrence (DR) risk of less than 5%. Subsequent validation in patients who did not receive any primary adjuvant endocrine therapy in the Netherlands Cancer Registry (NCR) cohort (n = 1247) confirmed the adjusted BCI model was significantly prognostic (p = 0.003). Across the Stockholm and NCR studies, 20% and 16% of patients were identified by the BCI test as minimal risk, with a 10-year DR risk of 2.3% and 4.5%, respectively.³

“While further validation is needed prior to availability of this new Breast Cancer Index prognostic assessment, these results suggest an expanded potential of the BCI test,” said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. “Identifying women with a sufficiently low risk of cancer recurrence could enable them, with the appropriate guidance of their medical care team, to consider de-escalation of primary adjuvant endocrine therapy, thereby reducing unnecessary side effects and toxicity.”

Three additional investigational studies being presented at the SABCS conference related to the Breast Cancer Index test include:

• Associations Between Breast Cancer Index Test Classifications and MSK-IMPACT Genomic Profiles in HR+/HER2- Breast Cancer [#P1-11-07]⁴.
• Impact of NCCN/ASCO Guidelines and Epic Software Enhancement on Utilization of the Breast Cancer Index Test and Its Role in the Quality of Cancer Care at Community Centers [#P4-09-26]⁵.
• Correlative Analysis of Breast Cancer Index Test With Body Mass Index for Prediction of Extended Endocrine Therapy Benefit in the BCI Registry Study [#P4-11-04]⁶.

“We continue to be encouraged by the additional potential clinical utility of the Breast Cancer Index test and look forward to exploring more opportunities to address the continuum of care in breast health,” added Schneiders.

About the Breast Cancer Index Test

The Breast Cancer Index test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The American Society of Clinical Oncology (ASCO), European Group on Tumor Markers (EGTM) and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) acknowledge the Breast Cancer Index test as a biomarker to help inform extended endocrine treatment decisions.^1,2 It is the only test recognized by guidelines to predict the likelihood of benefit from extended endocrine therapy.^1,2

The Breast Cancer Index test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a laboratory-developed test (LDT) performed in a single CLIA-certified and CAP-accredited diagnostic laboratory. For more information, visit www.breastcancerindex.com.

About Hologic

Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnosis and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X (Twitter), Instagram and YouTube.

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.

Hologic and The Science of Sure are trademarks and/or registered trademarks of Hologic Inc. and/or its subsidiaries in the United States and/or other countries.

References

¹Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer V.4.2023.^© National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed December 15, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

²Andre F et al. J Clin Oncol. Published online April 19, 2022. DOI: 10.1200/JCO.22.00069. Referenced with permission from the American Society of Clinical Oncology (ASCO®) Clinical Practice Guideline Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer. © American Society of Clinical Oncology. 2024. All rights reserved. To view the most recent and complete version of the guideline, go online to https://ascopubs.org/jco/special/guidelines [ascopubs.org]. ASCO makes no warranties of any kind whatsoever regarding their content, use of application and disclaims any responsibility for their application or use in any way.

³Jilderda M. An Adjusted Breast Cancer Index Model to Identify Women with Hormone Receptor-Positive (HR+) Breast Cancer at Minimal Risk of 10-year Distant Recurrence (DR). Poster presented at: 47^th Annual San Antonio Breast Cancer Symposium; December 10-13; San Antonio, TX.

⁴Zhang H. Associations between Breast Cancer Index Classifications and MSK-IMPACT Genomic Profiles in HR+/HER2- Breast Cancer. Poster presented at: 47^th Annual San Antonio Breast Cancer Symposium; December 10-13; San Antonio, TX.

⁵Tran C. Impact of NCCN/ASCO Guidelines and Epic Software Enhancement on Utilization of the Breast Cancer Index Test and its Role in the Quality of Cancer Care at Community Centers. Poster presented at: 47^th Annual San Antonio Breast Cancer Symposium; December 10-13; San Antonio, TX.

⁶Siuliukina N. Correlative analysis of Breast Cancer Index with Body Mass Index for prediction of extended endocrine therapy benefit in the BCI Registry Study. Poster presented at: 47^th Annual San Antonio Breast Cancer Symposium; December 10-13; San Antonio, TX.