New Data To Be Presented at SABCS 2024 Investigates the Potential Role of the Breast Cancer Index® Test in Identifying Patients With Minimal Risk of Distant Recurrence
Four new studies about the Breast Cancer Index (BCI) test will be presented at the 2024 San Antonio Breast Cancer Symposium. The main study investigates BCI's potential to identify postmenopausal women with HR+ early-stage breast cancer who have minimal risk of distant recurrence.
The research validated an adjusted BCI prognostic model that identified a 'minimal risk' group with less than 5% 10-year distant recurrence risk. In the Stockholm and NCR studies, 20% and 16% of patients were identified as minimal risk, with 10-year distant recurrence risks of 2.3% and 4.5%, respectively.
The BCI test is currently recognized by NCCN and ASCO guidelines as the only test predicting which HR+ early-stage breast cancer patients may benefit from extended endocrine therapy beyond five years.
Quattro nuovi studi riguardanti il test Breast Cancer Index (BCI) saranno presentati al San Antonio Breast Cancer Symposium 2024. Lo studio principale indaga il potenziale del BCI di identificare donne in postmenopausa con cancro al seno in fase iniziale HR+ che presentano un rischio minimo di recidiva distante.
La ricerca ha convalidato un modello prognostico BCI aggiustato che ha identificato un gruppo a 'rischio minimo' con un rischio di recidiva distante inferiore al 5% a 10 anni. Negli studi di Stoccolma e NCR, il 20% e il 16% dei pazienti sono stati identificati come a rischio minimo, con rischi di recidiva distante a 10 anni dell'2,3% e del 4,5%, rispettivamente.
Il test BCI è attualmente riconosciuto dalle linee guida NCCN e ASCO come l'unico test in grado di prevedere quali pazienti con cancro al seno in fase iniziale HR+ possano beneficiare di una terapia endocrina prolungata oltre i cinque anni.
Cuatro nuevos estudios sobre el test Breast Cancer Index (BCI) serán presentados en el Simposio sobre Cáncer de Mama de San Antonio 2024. El estudio principal investiga el potencial del BCI para identificar a mujeres posmenopáusicas con cáncer de mama HR+ en etapa temprana que tienen un riesgo mínimo de recurrencia distante.
La investigación validó un modelo pronóstico BCI ajustado que identificó un grupo de 'mínimo riesgo' con menos del 5% de riesgo de recurrencia distante a 10 años. En los estudios de Estocolmo y NCR, el 20% y el 16% de los pacientes fueron identificados como de riesgo mínimo, con riesgos de recurrencia distante a 10 años del 2.3% y el 4.5%, respectivamente.
El test BCI es actualmente reconocido por las guías NCCN y ASCO como el único test que predice qué pacientes con cáncer de mama HR+ en etapa temprana podrían beneficiarse de una terapia endocrina extendida más allá de cinco años.
2024년 샌안토니오 유방암 심포지엄에서 유방암 지수(Breast Cancer Index, BCI)에 관한 네 가지 새로운 연구가 발표될 예정입니다. 주요 연구는 원거리 재발 위험이 최소인 초기 단계 HR+ 유방암 환자인 폐경 후 여성들을 BCI가 식별할 수 있는 가능성을 조사합니다.
이 연구는 10년 간 원거리 재발 위험이 5% 미만인 '최소 위험' 그룹을 확인한 조정된 BCI 예측 모델을 검증했습니다. 스톡홀름 및 NCR 연구에서 각각 20%와 16%의 환자가 최소 위험으로 식별되었으며, 10년 간 원거리 재발 위험은 각각 2.3%와 4.5%였습니다.
BCI 테스트는 현재 NCCN 및 ASCO 가이드라인에서 5년 이상 장기 내분비 치료의 혜택을 받을 수 있는 HR+ 초기 단계 유방암 환자를 예측할 수 있는 유일한 테스트로 인정받고 있습니다.
Quatre nouvelles études concernant le test Breast Cancer Index (BCI) seront présentées lors du Symposium sur le Cancer du Sein de San Antonio 2024. L'étude principale examine le potentiel du BCI à identifier les femmes post-ménopausées atteintes d'un cancer du sein précoce HR+ qui ont un risque minimal de récidive à distance.
La recherche a validé un modèle prognostique BCI ajusté qui a identifié un groupe à 'risque minimal' avec un risque de récidive à distance de moins de 5 % sur 10 ans. Dans les études de Stockholm et NCR, 20 % et 16 % des patientes ont été identifiées comme à risque minimal, avec des risques de récidive à distance de 2,3 % et 4,5 % respectivement après 10 ans.
Le test BCI est actuellement reconnu par les directives de la NCCN et de l'ASCO comme le seul test prédisant quelles patientes atteintes de cancer du sein précoce HR+ pourraient bénéficier d'une thérapie endocrinienne prolongée au-delà de cinq ans.
Vier neue Studien zum Breast Cancer Index (BCI)-Test werden beim San Antonio Breast Cancer Symposium 2024 vorgestellt. Die Hauptstudie untersucht das Potenzial des BCI, postmenopausale Frauen mit HR+ frühem Brustkrebs zu identifizieren, die ein minimales Risiko einer fernen Rückkehr haben.
Die Forschung validierte ein angepasstes BCI-Prognosemodell, das eine 'minimales Risiko'-Gruppe mit weniger als 5% Risiko einer 10-jährigen fernen Rückkehr identifizierte. In den Studien in Stockholm und NCR wurden 20% bzw. 16% der Patienten als minimales Risiko identifiziert, mit einem Risiko einer fernen Rückkehr in 10 Jahren von 2,3% bzw. 4,5%.
Der BCI-Test wird derzeit von den NCCN- und ASCO-Richtlinien als der einzige Test anerkannt, der vorhersagen kann, welche HR+ frühkindlichen Brustkrebs-Patienten von einer erweiterten endokrinen Therapie über fünf Jahre hinaus profitieren können.
- BCI test successfully identified patients with minimal recurrence risk (2.3-4.5% at 10 years)
- Validation study confirmed significant prognostic value of adjusted BCI model (p = 0.003)
- BCI is the only test recognized by NCCN and ASCO for predicting extended endocrine therapy benefit
- Further validation required before new prognostic assessment becomes available
Insights
This research on the Breast Cancer Index (BCI) test, while scientifically interesting, represents preliminary data that will be presented at a future conference. The study's findings about identifying patients with minimal recurrence risk (
The validation cohort results showing
Study Assesses Prognostic Value of BCI Testing and Its Potential in Supporting De-escalation of Primary Adjuvant Endocrine Therapy
“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
“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.
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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: 47th Annual San Antonio Breast Cancer Symposium; December 10-13;
4Zhang H. Associations between Breast Cancer Index Classifications and MSK-IMPACT Genomic Profiles in HR+/HER2- Breast Cancer. Poster presented at: 47th Annual San Antonio Breast Cancer Symposium; December 10-13;
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: 47th Annual San Antonio Breast Cancer Symposium; December 10-13;
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: 47th Annual San Antonio Breast Cancer Symposium; December 10-13;
SOURCE: Hologic, Inc.
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FAQ
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