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Background: The estrogen receptor (ER) is one of the key biomarkers in breast cancer (BC), and therapy decisions are based on ER expression levels. However, the benefit of endocrine therapy in patients with ER expression (ER1%–20%) is debatable. Owing to aggressive tumor biology, like triple-negative BC patients, many ER1%–20% patients are considered to have worse outcomes and may benefit from additional drugs. This treatment dilemma in ER1%–20% patients can be addressed by prognostication for risk of recurrence, which remains underexplored. Objective: The study aims to assess whether CanAssist Breast (CAB), an immunohistochemistry-based prognostic test validated globally in ER+/PR+/HER2− early-stage breast cancer (EBC) patients, would help prognosticate ER1%–20% patients and thereby aid in treatment planning. Design: We conducted secondary data analyses of previously published retrospective studies to evaluate CAB prognostication in ER1%–20% and ER>20% subgroups across different clinical parameters. Methods: Analysis of CAB-based risk stratification was conducted on 2896 ER+/PR+/HER2− EBC patients with a known percentage of ER staining in both ER1%–20% and ER>20% subgroups. Kaplan–Meier survival curves were used to evaluate distant recurrence-free interval (DRFI). Results: ER1%–20% patients constituted 6% of the total cohort. Overall, CAB significantly identified 65% of ER1%–20% patients as low risk (LR) with acceptable DRFI of 91% and 35% as high risk (HR) with worse DRFI of 61% (p < 0.0001; hazard ratio (HR/LR), 5.175). ER1%–20% patients are mostly younger, with T2, grade 3, lymph node positive tumors, and have a twofold higher incidence of distant recurrence than ER>20% patients. CAB-based prognostication was significant in these subgroups analyzed with acceptable DRFI in LR patients of ~90% and a drop in DRFI in HR patients to ⩽66% (p = 0.01 to p < 0.0001). Conclusion: CAB-based risk stratification of ER1%–20% patients is significant and would add value in treatment decisions for additional targeted treatments to HR patients. Plain language summary CanAssist Breast guides treatment decisions in early-stage breast cancer patients with low-intermediate estrogen receptor expression Estrogen receptor (ER) expression is a critical biomarker in breast cancer, influencing prognosis and guiding therapeutic decisions. Tumors with low-intermediate ER expression (1%-20%) are typically considered to exhibit aggressive biology, recur more often, and thus are often managed with more intensive treatment strategies. However, emerging evidence suggests that a subset of ER1%-20% tumors may not display aggressive tumor biology and could benefit from standard therapy alone (endocrine therapy ± chemotherapy). Thus, it is critical to assess the underlying tumor biology in these patients with ER1%-20% tumors to help plan optimum treatment. Stratifying ER1%-20% patients based on underlying tumor biology remains a clinical challenge. This retrospective study evaluates the utility of CanAssist Breast, a prognostic assay, in distinguishing ER1%-20% patients as ‘low risk’ or ‘high risk’ for cancer recurrence based on underlying tumor biology. Low-risk patients may be de-escalated from additional intensive treatments, thereby optimizing therapeutic decisions in a population with historically limited guidance.

CanAssist Breast (CAB), an immunohistochemistry (IHC) and artificial intelligence-based prognostic test, was developed on Hormone receptor-positive (HR +), HER2/neu-negative (HER2-) breast tumors from Indian patients and validated in retrospective global studies. CAB combines the expression of five protein biomarkers with three clinical parameters to segregate patients as low-risk (LR) or high-risk (HR) for distant recurrence. CAB has been in clinical use in South Asia, UAE, Turkey, and Iran for the last 8 years on > 7000 Early breast cancer (EBC) patients. Here we showcase for the first time, the real-world data on the usefulness of CAB to prognosticate across different clinicopathological parameters, histological types, and impact on treatment planning by analysing CAB usage in 5926 patients diagnosed from mid-2016 to 2024. Overall, CAB stratified 72% of patients as LR and 28% as HR for distant recurrence. Interestingly, CAB showed meaningful differences in HR proportions across different histological types; 19% and 29% in mucinous versus mixed mucinous, while 26% and 50% in papillary and micropapillary carcinomas, respectively. In the intermediate Ki67 group, CAB segregated 77% of patients as LR and 23% as HR. In conclusion, CAB is a first-of-its-kind prognostic test that serves as a cost-effective, suitable alternative to Western prognostic tests.

Background Hormone receptor (HR)-positive, HER2/neu-negative breast cancers have a sustained risk of recurrence up to 20 years from diagnosis. TEAM (Tamoxifen, Exemestane Adjuvant Multinational) is a large, multi-country, phase III trial that randomized 9776 women for the use of hormonal therapy. Of these 2754 were Dutch patients. The current study aims for the first time to correlate the ten-year clinical outcomes with predictions by CanAssist Breast (CAB)—a prognostic test developed in South East Asia, on a Dutch sub-cohort that participated in the TEAM. The total Dutch TEAM cohort and the current Dutch sub-cohort were almost similar with respect to patient age and tumor anatomical features. Methods Of the 2754 patients from the Netherlands, which are part of the original TEAM trial, 592 patients’ samples were available with Leiden University Medical Center (LUMC). The risk stratification of CAB was correlated with outcomes of patients using logistic regression approaches entailing Kaplan–Meier survival curves, univariate and multivariate cox-regression hazards model. We used hazard ratios (HRs), the cumulative incidence of distant metastasis/death due to breast cancer (DM), and distant recurrence-free interval (DRFi) for assessment. Results Out of 433 patients finally included, the majority, 68.4% had lymph node-positive disease, while only a minority received chemotherapy (20.8%) in addition to endocrine therapy. CAB stratified 67.5% of the total cohort as low-risk [DM = 11.5% (95% CI, 7.6–15.2)] and 32.5% as high-risk [DM = 30.2% (95% CI, 21.9–37.6)] with an HR of 2.90 (95% CI, 1.75–4.80; P  < 0.001) at ten years. CAB risk score was an independent prognostic factor in the consideration of clinical parameters in multivariate analysis. At ten years, CAB high-risk had the worst DRFi of 69.8%, CAB low-risk in the exemestane monotherapy arm had the best DRFi of 92.7% [ vs CAB high-risk, HR, 0.21 (95% CI, 0.11–0.43), P  < 0.001], and CAB low-risk in the sequential arm had a DRFi of 84.2% [ vs CAB high-risk, HR, 0.48 (95% CI, 0.28–0.82), P  = 0.009]. Conclusions Cost-effective CAB is a statistically robust prognostic and predictive tool for ten-year DM for postmenopausal women with HR+/HER2−, early breast cancer. CAB low-risk patients who received exemestane monotherapy had an excellent ten-year DRFi.

Introduction Core needle biopsies (CNB) are being increasingly utilized for biomarker, prognostic, and predictive testing in breast cancer (BC). CanAssist Breast (CAB) is a prognostic test performed to assess the 'risk of breast cancer recurrence' in early-stage hormone receptor-positive, Her2-negative BC patients. CAB segregates tumors as 'low risk' or 'high risk' for distant recurrence. Risk assessment done by CAB aids in planning and making adjuvant chemotherapy or hormone therapy decisions. CAB is typically performed on surgical specimens (SS). However, performing it on CNB does offer additional insights into tumor biology leading to different strategies for treatment planning; hence, we aimed to compare the risk stratification performance of CAB using CNB versus SS. Method We analyzed 103 paired formalin-fixed paraffin-embedded CNB and SS samples from hormone receptor-positive, Her2-negative early BC tissue samples submitted for performing CAB at OncoStem Diagnostics between November 2021 and September 2023. Concordance on 'risk categories' of CAB performed on CNB versus SS was reported using overall percentage agreement and Pearson correlation coefficient. Results We found excellent overall concordance of 92.2% for CAB risk stratification between paired CNB and SS tumor samples with a strong Pearson correlation coefficient of r= 0.8351 (p< 0.0001) when either SS or CNB was used as the gold standard. In prognostic testing patients with a 'low risk' of recurrence may avoid chemotherapy and hence it is crucial to assess the accuracy of CAB in the low-risk category. Additionally, in a real-world scenario, it is more likely that CAB will be performed on CNB first. Conclusion CAB when performed on CNB samples showed high concordance with SS thus demonstrating that CNB was a suitable sample for the CanAssist Breast test. The accuracy in the low-risk category is 97.5%, which ensures that physicians can reliably use prognostic information by testing CNB to guide adjuvant therapy decisions.