ER positive + HER-2 negative

Clinicopathologic features including patient age, race, clinical T category, grade, Ki67, ER/PR expression, and tumor location are associated with nodal positivity in women 50-69 years of age with cT1N0, ER+HER2- breast cancer. The 21-gene RS is not associated with nodal positivity. This predictive model is able to identify women at high risk for nodal metastasis and may help multidisciplinary teams as they look to consider de-escalating SLN surgery in breast cancer.

The nomogram, integrating CESM deep learning with clinical-pathological features, proved valuable for predicting NAC response in patients with ER-positive/HER2-negative breast cancer. Nomogram outperformed deep learning-based and clinical models.

P1/2, N=15, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Apr 2024 | Trial primary completion date: Dec 2025 --> Apr 2024

The study showed that a subgroup of patients with a clinical high risk and a genomic low risk ER+/HER2-breast cancer benefits from NET resulting in BCS instead of a mastectomy. Additionally, NET may enable de-escalation in axillary treatment.

The results from this clinical evaluation of image-based risk stratification shows a considerable agreement to an established gene expression assay in routine breast pathology.

P=N/A, N=24, Recruiting, BioCorteX Inc | N=60 --> 24

Although the acelERA BC study did not reach statistical significance for its primary INV-PFS end point, there was a consistent treatment effect with giredestrant across most key subgroups and a trend toward favorable benefit among patients with ESR1-mutated tumors. Giredestrant was well tolerated, with a safety profile comparable to PCET and consistent with known endocrine therapy risks. Overall, these data support the continued investigation of giredestrant in other studies.

Predictive biomarkers of response to neo-adjuvant chemotherapy and hormonal therapies are instrumental for selecting ER positive/HER2 negative breast cancer patients for each treatment. Chemotherapy remains the standard of care for many of those patients requiring neo-adjuvant treatment, but other neo-adjuvant therapies are increasingly used.

While there now exist well-validated geriatric assessment tools whose use is encouraged by the American Society of Clinical Oncology when considering systemic therapy, these instruments have not been widely integrated into the locoregional breast cancer care model. This review aims to highlight the importance of assessing frailty and the concepts of and over- and undertreatment, in the context of trial data supporting opportunities for safe deescalation of locoregional therapy, when treating older women with early-stage breast cancer.

Abemaciclib was originally FDA approved for patients with ER-positive/HER2-negative breast cancer with Ki-67 expression ≥20%...The average Ki-67 difference was 4.36 for CNB vs RES, 6.95 for CNB versus ALN, and RES versus ALN (P=0.93, 0.99, and 0.94, respectively). Our study concludes that further refinement in Ki-67 scoring is advisable to reduce clinically significant variation.

P2, N=81, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2024 --> Feb 2025

P=N/A, N=60, Recruiting, BioCorteX Inc | Not yet recruiting --> Recruiting

No abstract available

In contrast, GRHL2 preserves commonly accessible regions shared between Group-P and Group-B in Group-B cells, suggesting that FOXA1 and GRHL2 play a pivotal role in preserving distinct chromatin accessibility patterns for each group. Specifically, FOXA1 distinguishes between receptor-positive and TNBC cell lines, whereas GRHL2 distinguishes between basal-like and mesenchymal subtypes in TNBC lines.

P=N/A; Recruiting --> Active, not recruiting

[18F]FDG-PET is a powerful tool to detect metastases, including invasive lobular carcinoma. Although BC histopathological characteristics are related to [18F]FDG uptake, [18F]FDG-PET and biopsy remain complementary in MBC staging (NCT01957332).

Implementation of a test send out protocol that supports trained nurses in identifying which patients are eligible for Oncotype DX® testing can significantly decrease turn-around times and lead to more meaningful and productive oncology visits. When clinical oncologists and surgical oncologists work together with nurses to establish clear workflows and document appropriately, care coordination improves. Tracking send out test orders in the pathology lab allows pathologists to identify trends in ordering practices and track turn-around times.

In our patient population, there is an incremental difference in the average HER2 score by the Oncotype assay as the tumors progress from IHC score 0 to IHC score 2+/ISH negative. The negative/score 0 had an average HER2 of 8.9 while the negative/"HER2 low" averaged 9.4. However, whether this slight change reflects a meaningful biologic difference between the tumors is unknown.

Findings suggest ME3 would have more accurately predicted chemotherapeutic response over MP. While both methods identified the cases with significant responses to chemotherapy, MP overpredicted the number of cases that would benefit. Therefore, ME3 may represent a more accurate, accessible, and cost-effective way to predict response to NA chemotherapy.

Enobosarm has anti-tumour activity in patients with ER-positive, HER2-negative advanced breast cancer, showing that AR activation can result in clinical benefit, supporting further clinical investigation of selective AR activation strategies for the treatment of AR-positive, ER-positive, HER2-negative advanced breast cancer.

Individual trials of abemaciclib, palbociclib, and ribociclib show a similar impact on progression-free survival yet differing statistical significance for overall survival (OS). Real-world data analyses may help to identify if there is a meaningful inter-drug difference in efficacy. Significant differences between CDK4/6i are observed for safety and tolerability outcomes.

In patients without lymph node metastasis, the presence of residual PIC component only was associated with worse disease-free survival (p = 0.004). Although the number of published studies still limited, residual residual PIC component only after NAC is associated with poor outcome, and it should not be considered as pathological complete response.

A total of 47.7% of patients who received total mastectomy after neoadjuvant chemotherapy were breast-conserving surgery eligible, which was significantly higher than that of non-neoadjuvant chemotherapy patients. Magnetic resonance imaging contributed the most to false size predictions.

P3; Not yet recruiting --> Recruiting

Background: The PENELOPE-B phase III trial investigated the addition of one year of palbociclib to endocrine therapy (ET), in patients with hormone receptor positive HER2 negative breast cancer with residual invasive disease after neoadjuvant chemotherapy... Detection of ctDNA following neoadjuvant chemotherapy, and surgery, is associated with a very high risk of early relapse suggesting limited efficacy of adjuvant ET. Clinical imaging and studies of experimental therapy are warranted in this patient population. Testing ctDNA after recent neoadjuvant chemotherapy in luminal-A like breast cancer has relatively low ‘sensitivity’ for predicting future relapse, in particular for later relapses, in part suggesting that response to neoadjuvant chemotherapy may reduce ctDNA detection

We conclude that the Ki67 entropy indicator enables a more comprehensive risk assessment with regard to BCSS, especially in cases with borderline Ki67 proliferation rates. The study further demonstrates the benefits of high-capacity DIA-generated data for quantifying the essentially subvisual ITH properties.

ENDOPREDICT PROVED TO BE AN EFFECTIVE THERAPEUTIC DECISION TOOL, WITH FAVORABLE PROGNOSTIC POWER IN WOMEN WITH BREAST CANCER TREATED WITH HORMONOTHERAPY ALONE.

The RS was clinically validated as a predictive biomarker for NHB, Hispanic, and NHW women with ER-positive, axillary node-negative breast cancer, but it may underestimate the benefit of chemotherapy for young NHB women. If this finding is confirmed, the RS cutoff for recommending adjuvant chemotherapy for young NHB women with ER-positive, axillary node-negative breast cancer may need to be lower than for other women.

Acknowledging the short median follow-up time at interim analysis, our initial results indicate that delivering IORT through HDR brachytherapy in carefully selected breast cancer patients is feasible and oncological safe so far. A long-term follow-up is essential to confirm the initial results.

P=N/A, N=24, Active, not recruiting, Shengjing Hospital | Trial completion date: Oct 2023 --> Dec 2028 | Trial primary completion date: Jul 2023 --> Dec 2024

P2, N=58, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Jul 2024

The combined model incorporating clinicopathologic and MRI features showed potential in predicting the low MammaPrint risk group, and may support decision-making in clinical settings with limited access to MammaPrint.

P2, N=180, Completed, Canadian Cancer Trials Group | Trial completion date: Nov 2018 --> Nov 2023

P1, N=181, Active, not recruiting, Genentech, Inc. | Phase classification: P1a/1b --> P1

Oral administration of TQB3616 showed more potent antitumor activity than abemaciclib in an in vitro breast cancer xenograft model, causing significant tumor regression associated with sustained target inhibition in tumor tissue and manageable in vivo toxicity. The results of this study indicate that TQB3616 is a novel CDK4/6 inhibitor, and its highly effective antitumor activity against breast cancer is expected to yield promising therapeutic effects in clinical studies.

This study illustrates how the integration of clinical pharmacology considerations into early-phase clinical trials can inform the design of pivotal studies and accelerate oncology drug development.

High Ki-67 after NET is associated with worse survival outcomes, even after a short course of NET, emphasising the prognostic value of this biomarker in women with ER-positive/HER2-negative early breast cancer.

AI-based detection of TILs counts, and their spatial distribution provides prognostic value in luminal early-stage BC patients. The utilisation of AI algorithms could provide a comprehensive assessment of TILs as a morphological variable in WSIs beyond eyeballing assessment.

According to the study, maintained baseline ALC was identified as a universal biomarker for ERI regardless of the treatment line in ER+HER2-ABC pts; however, the dynamic change in ALC had no predictive significance.

Patients with risk factors for late recurrence should be considered for extended endocrine therapy. Longer DDFS and response to first-line treatment may be a prognostic factor for postrelapse survival after late recurrence.

While their data are quite interesting, some information crucial for interpreting the results of this study is missing. Therefore, I would like the authors to provide additional data.

P1/2, N=15, Active, not recruiting, M.D. Anderson Cancer Center | N=54 --> 15 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025