ER positive + HER-2 negative

The RICE trial represents a significant step in breast cancer treatment, offering insights that could lead to treatment protocols with minimized RT appointments and enhanced patient outcomes.

Implementing the Oncotype DX test for women with ER-positive and HER2-negative early breast cancer is of great value. Delayed implementation leads to increased costs, reduced quality of life, and life-years lost.

No abstract available

Camizestrant at 75 and 150 mg showed a significant benefit in progression-free survival versus fulvestrant. These results support further development of camizestrant for the treatment of oestrogen receptor-positive, HER2-negative breast cancer.

P1, N=23, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Oct 2025

The multi-model approach achieved an AUC of 0.91 (95% CI: 0.87-0.95) on the internal set and an AUC of 0.84 (95% CI: 0.78-0.89) on the external cohort for predicting low- and high-breast cancer recurrence risk categories based on the Oncotype DX recurrence score. With further validation, the proposed methodology could provide an alternative to assist clinicians in personalizing treatment for breast cancer patients and potentially improving their outcomes.

Significantly higher eligibility rates were observed in patients who underwent a mastectomy, >70 years and ≤40 years for adjuvant abemaciclib and ribociclib, and in patients >80 years for ribociclib. A higher discontinuation rate for abemaciclib was reported in patients aged ≥65 years and it can be assumed that discontinuation rates may increase in even older patients. If the results of the NataLEE trial translate into clinical practice, the number of patients potentially eligible for adjuvant CDK4/6 inhibitors may increase, especially in the elderly population.

ER-positive/HER2-negative BC in AYA was highly proliferative with high immune cell infiltration compared with the other age groups.

In this large, prospective, global patient cohort, no differences were observed in clinical parameters, prognosis, or differential benefit from palbociclib between HER2-0 and HER2-low tumors. Significant geographic variability was observed in the prevalence of HER2-low status, suggesting a high degree of variation in pathologic assessment of HER2 expression without impact on outcomes.

Between 2011 and 2022, assay use resulted in a 58% reduction in chemotherapy administration and net savings of over €3.3 million.

The addition of letrozole to standard neoadjuvant chemotherapy was safe and beneficial in terms of overall response rate, but did not provide a higher pCR rate in locally advanced HR-positive, HER2-negative breast cancer. Further research is needed to enhance neoadjuvant treatment strategies for this cancer subtype.

P3, N=287, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2025

The combination of TILs and MRI is informative of response to NAC in patients with both ER+/HER2- and TN&HER2+ tumors.

In cN0, postmenopausal ER-positive/HER2-negative patients who underwent BCT, patients with cT1 tumors had lower rate of LN metastasis, and there were fewer instances of HNB. Therefore, in these patients, omission of axillary surgery including SLNB can be carefully considered.

NLR at EOT with CDK4/6 inhibitors is a significant and independent prognostic marker for patients with ER-positive HER2-negative advanced breast cancer.

No such effect was observed for ESR1 mutations, with a rate ratio of 1.15 (confidence interval 0.67-1.95). We conclude that ER loss and ESR1 mutation together account for 30% of the resistance to endocrine therapy.

We present the largest study of BC variant frequencies in a cohort of Irish breast cancer patients to date and confirm NGS is feasible and identifies clinically relevant and actionable variants. We confirm that the frequency of PIK3CA alterations, in addition to codon specificity, are comparable to those observed in European and US cohorts and demonstrate that the detection of clinically relevant biomarkers is not confined to ER positive HER2 negative BC. The tissue failure rate (19%) underscores the need for cfDNA testing to identify the expanding range of actionable targets in BC to improve access to emerging targeted therapies and biomarker-driven clinical trials.

P1/2, N=66, Active, not recruiting, Stephen Shiao | Trial primary completion date: Mar 2022 --> Dec 2024

The DESTINY-Breast04 trial results showed that trastuzumab deruxtecan (T-DXd) significantly prolonged the survival of patients with HER2-low breast cancer, thus presenting a paradigm shift in anti-HER2 therapy...We inferred that the HER2-low and HER2-zero statuses do not affect the RFS and OS of patients with ER-positive breast cancer. The prognostic significance of HER2-low or HER2-zero status in luminal A- and B-like breast cancers might differ, and a new treatment strategy is required for the HER2-low subgroup.

P2, N=240, Active, not recruiting, AstraZeneca | Trial completion date: Mar 2024 --> Mar 2025

P=N/A, N=221, Not yet recruiting, Università Vita-Salute San Raffaele | Phase classification: P2 --> P=N/A | Initiation date: Oct 2023 --> Oct 2024

In conclusion, the study we presented demonstrated that NK cells in ER+/HER2-BC were hypofunctional, and S100A9 was an important regulator of NK cell function in ER+BC. Our work contributes to elucidate the regulatory networks between cancer cells and NK cells and may provide theoretical basis for novel drug development.

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.