Breast Cancer Index Test Shows Promise for Identifying Low-Risk Premenopausal Patients Who May Avoid Aggressive Therapy
核心洞察
Eleven studies featuring the Breast Cancer (搜索) Index (BCI) Test will be presented at the 2025 San Antonio Breast Cancer Symposium, exploring expanded utility in premenopausal women with early-stage hormone receptor-positive breast cancer (搜索).
A key study demonstrates the BCI Test's potential to identify premenopausal patients at minimal risk of metastatic recurrence (搜索) who may safely forgo ovarian function suppression therapy (搜索).
The research includes translational analysis of two major ovarian function suppression trials (SOFT and TEXT) and comparative analyses with the 21-gene assay for treatment decision-making.
Hologic, Inc. and its subsidiary Biotheranostics (搜索), Inc. announced that eleven studies featuring the Breast Cancer (搜索) Index (BCI) Test will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), with findings that could expand the test's utility in premenopausal women with early-stage, hormone receptor-positive (HR+) breast cancer.
The research builds on the BCI Test's established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy (搜索). The new studies explore potential expanded applications in premenopausal populations and provide comparative analyses with the 21-gene assay for extended endocrine therapy treatment decisions.
Key Study Highlights Potential for Treatment De-escalation
Among the most significant findings is a study titled "Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer (搜索) at Minimal Risk of Distant Recurrence by Breast Cancer Index." This research explores the BCI Test's potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence (搜索).
The study presents results from a translational analysis of two major landmark ovarian function suppression (OFS) trials: the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT). The findings support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy (搜索).
"As we observe an increasing number of women being diagnosed with breast cancer (搜索) at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life," said primary study author Dr. Ruth O'Regan, MD. "The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects."
Comprehensive Research Program Demonstrates Test Versatility
The research program includes studies examining the BCI Test's performance across diverse patient populations and clinical scenarios. Notable investigations include analyses of endocrine sensitivity and predicted benefit of extended endocrine therapy (搜索) in BRCA1 (搜索), BRCA2 (搜索), and CHEK2 (搜索) pathogenic variant carriers with ER+/HER2 (搜索)- breast cancer (搜索).
Another significant study demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning. The "Breast Cancer (搜索) Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy (搜索) Benefit" study emphasizes the need to use the right test for each clinical decision.
Additional research explores the test's prognostic performance in patients with early-stage HR+ HER2 (搜索)+ breast cancer (搜索) treated with adjuvant trastuzumab, comparative analysis of BCI Testing in Hispanic and non-Hispanic populations, and comparison of BCI scores from core-needle biopsies versus surgical excisions.
Clinical Impact and Guideline Recognition
"These data reinforce Hologic's continued commitment to oncology innovation and advancing precision diagnostics in breast cancer (搜索) care," said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. "This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy (搜索) decision-making and highlights the consistency of the BCI Test's performance across diverse patient subgroups and sample types."
The BCI Test has achieved guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. Both the ASCO Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology acknowledge the Breast Cancer Index Test (搜索) as a biomarker to help inform extended endocrine treatment decisions, making it the only test recognized by guidelines to predict which early-stage, HR+ breast cancer (搜索) patients are likely to benefit from extended endocrine therapy (搜索).
Real-World Clinical Adoption
With more than a decade of clinical use by over 9,000 providers, the BCI Test has demonstrated proven ability to influence extended endocrine therapy (搜索) decisions. The test is uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer (搜索), helping oncology care teams and patients navigate the difficult trade-offs between preventing disease recurrence and facing significant side effects from unnecessary treatment.
"The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test," said Schneiders. "With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy (搜索) decisions, it's encouraging to see additional real-world and independent data reinforcing the BCI Test's impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients."