New Data Presented at SABCS 2022 Reveal Expanded Predictive Value of the Breast Cancer Index™ Test for Ovarian Function Suppression in Premenopausal Women with HR+ Breast Cancer
Hologic and its subsidiary Biotheranostics announced groundbreaking results at the 2022 San Antonio Breast Cancer Symposium, revealing that the Breast Cancer Index test effectively predicts treatment benefits from ovarian function suppression for premenopausal patients with early-stage HR+ breast cancer. The test identified 58% of patients who benefitted from combining ovarian function suppression with endocrine therapy, showing a significant absolute benefit of 11.6%. This data supports the test's role in personalized treatment approaches in oncology.
- Breast Cancer Index test identified 58% of premenopausal women who benefit from ovarian function suppression, showcasing a substantial absolute benefit of 11.6%.
- Test shows predictive performance consistent across various patient subgroups, enhancing its application in personalized treatment plans.
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The Breast Cancer Index Test Is the First Biomarker to Predict Treatment Benefit in the SOFT Trial
“There is a significant need for biomarkers to aid in treatment decisions for premenopausal women with breast cancer. Our study presented at SABCS is the first to examine a biomarker’s ability to determine benefit of ovarian function suppression in these women,” said Dr. Ruth O’Regan, Chair of Medicine and
The landmark SOFT trial was an international, three-arm, non-blinded, randomized clinical trial of 3,066 premenopausal women with HR+ breast cancer. The trial demonstrated that the addition of OFS to five years of primary adjuvant endocrine therapy (either tamoxifen or exemestane) reduced the risk of recurrence compared to adjuvant tamoxifen alone.2 OFS typically involves hormonal drug injections with a gonadotropin-releasing hormone (GnRH) agonist or surgical removal of the ovaries (bilateral oophorectomy).3 In an effort to evaluate the potential of a biomarker to assist in patient selection for this more intensive approach, the new study presented at SABCS evaluated the predictive and prognostic ability of the Breast Cancer Index test in a cohort of patient tumor samples (n=1,717) from the SOFT trial. Notably, the patient characteristics in this retrospective translational study were highly representative of the original SOFT trial.
The data found that the Breast Cancer Index genomic assay identified which premenopausal women with early-stage, HR+ breast cancer benefited from more intensive endocrine therapy (exemestane plus OFS) compared to tamoxifen alone. The Breast Cancer Index test identified
“Multiple clinical studies and national oncology guidelines affirm the predictive ability of the Breast Cancer Index test for extended endocrine therapy,” said
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 oncologists 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
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The company also champions women through the Hologic Global Women’s Health Index, which provides a science-backed data roadmap for improving women’s well-being, and Project Health Equality, which elevates awareness, research insights and access to quality care for underserved women.
Hologic, Breast Cancer Index, The Science of Sure and associated logos are trademarks and/or registered trademarks of
Forward-Looking Statements
This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Breast Cancer Index test. There can be no assurance that this test will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the test can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that the test will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to publicly release 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 statements are based.
References
1. https://www.sabcs.org/Program/Schedule-at-a-Glance. Accessed
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4341825/. Accessed
3. https://www.hopkinsmedicine.org/kimmel_cancer_center/cancers_we_treat/breast_cancer_program/treatment_and_services/survivorship/endocrine_therapy/premenopausal_women.html. Accessed
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2022. ©
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