Standardize Extended Endocrine Therapy Recommendations Using Guideline-Recognized Predictive Results

Extending endocrine therapy beyond 5 years may help some women with HR+, early-stage breast cancer reduce their risk of recurrence, but most do not benefit.^1–6 The Breast Cancer Index^® (BCITM) test is the only genomic assay recognized by the NCCN Clinical Practice Guidelines in Oncology (NCCN^® Guidelines) and the ASCO^® Clinical Practice Guideline to predict which patients are likely to benefit from extended endocrine therapy (EET).^7,8 The BCI test has demonstrated consistent predictive evidence in over 4,700 patients^9–13, and is guideline-recognized for patients with node negative or node positive (up to 3 positive nodes) disease, regardless of treatment with tamoxifen, aromatase inhibitor, or tamoxifen followed by aromatase inhibitor.^7,8

Data Shows Patients May Be Over- or Under-Treated Without BCI Testing

A multicenter prospective study of the first 1,000 patients enrolled in the BCI Registry study revealed that healthcare providers changed their extended endocrine therapy recommendations for ~40% of patients following BCI testing.¹⁴ These data highlight the importance of using the appropriate tool to determine the optimal length of endocrine therapy for each patient to help providers:

Avoid Overtreatment: Of the provider treatment decisions that changed, ~63% shifted from a YES to a NO recommendation for extended endocrine therapy.¹⁴ This finding suggests the critical role of BCI testing in helping identify women whose treatment may be discontinued after the first five years to avoid potential side effects and toxicities associated with longer endocrine therapy.
Avoid Undertreatment: The remaining ~37% of changes in provider treatment decisions shifted from a NO to a YES recommendation for extended endocrine therapy.¹⁴ This result highlights an equally important use of BCI testing: to identify women who may benefit from longer treatment to help avoid a potentially life-threatening metastatic recurrence when extended therapy may not have been previously recommended based on clinical and pathologic risk features alone.

Using the Appropriate Tool to Personalize Extended Endocrine Therapy Duration

Clinicopathologic features such as nodal status, tumor size and grade do not reliably predict benefit from longer treatment and may misinform extended endocrine therapy recommendations.^1,4,5 In fact, in patients assumed to have clinically low-risk disease (T1N0), the BCI test identified ~25% with a high risk of late-distant recurrence who were likely to benefit from extended endocrine therapy.¹⁵ On the other hand, in node-positive (N1) patients traditionally considered to have high risk, the BCI test identified ~22% as having limited risk of late distant recurrence,¹⁶ and ~69% were unlikely to benefit from extended endocrine therapy.¹⁷

Notably, the ASCO^® Clinical Practice Guideline also identifies other genomic assays such as OncotypeDX^®, EndoPredict^®, Prosigna^®, Ki67 and IHC4 as having insufficient evidence to guide extended endocrine decisions, further underscoring the importance of utilizing the appropriate tool for decision-making.⁸

With emerging technologies in precision medicine, guideline-recognized genomic tests that are established to predict therapy benefit are crucial to help guide more precise treatment recommendations for early-stage breast cancer survivors.

Learn more about the only guideline-recognized genomic test to predict extended endocrine therapy benefit at Booth 1343.

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References: 1. Goss PE, et al. J Natl Cancer Inst. 2005;97:1262-1271. 2. Jakesz R, et al. J Natl Cancer Inst. 2007;99:1845-1853. 3. Gray R, et al. J Clin Oncol. 2013;31:(suppl;abstr 5). 4. Davies C, et al. Lancet. 2013;381:805-816. 5. Goss PE, et al. N Engl J Med. 2016;375:209-219. 6. Mamounas EP, et al. J Natl Cancer Inst. 2023; 115:1302-1309. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer V.1.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed January 25, 2024. 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. 8. Andre 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. 9. Zhang Y, et al. Clin Cancer Res. 2013;19(15):4196-4205. 10. Sgroi DC, et al. J Natl Cancer Inst. 2013;105(14):1036-1042. 11. Bartlett JMS, et al. Clin Cancer Res. 2022; 28(9):1871-1880. 12. Noordhoek I, et al. Clin Cancer Res. 2021;27(1):311-319. 13. Mamounas EP, et al. Clin Cancer Res. 2024;30(9):1984-1991. 14. Sanft T, et al. J Natl Compr Canc Netw 2024; 22(2):99-107. Published Online March 2024. https://doi.org/10.6004/jnccn.2023.7087. 15. Schroeder B, et al. NPJ Breast Cancer. 2017;3:28 16. Zhang Y, et al. Clin Cancer Res. 2017;23(23):7217-7224. 17. Data on file; pulled from raw, unpublished data in the MGH validation study (Zhang et al CCR 2017).

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