HER-2 negative + ER positive

P3, N=312, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting

P2, N=252, Recruiting, Guangdong Provincial People's Hospital | Initiation date: Jan 2024 --> Sep 2024

P2, N=200, Active, not recruiting, Oana Danciu | Recruiting --> Active, not recruiting

With the evolving landscape of neoadjuvant therapies in development for HR-positive/HER2-negative breast cancer, ongoing work using quantitative biomarkers and genomic assay scores is needed to select the right neoadjuvant systemic therapy for the right patient. Given the increasing amount of data available at the time of breast cancer diagnosis, novel computational approaches are needed to integrate patient demographic and tumor-specific factors to predict the optimal treatment strategy and likelihood of BCS.

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

ALC can serve as a predictor of palbociclib efficacy in patients with metastatic ER-positive, HER2-negative breast cancer.

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.

P2, N=329, Active, not recruiting, Astellas Pharma Global Development, Inc. | Recruiting --> Active, not recruiting

P2, N=43, Recruiting, City of Hope Medical Center | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025

P3, N=180, Active, not recruiting, UNICANCER | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Jun 2025

P2, N=37, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

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.

P1/2, N=49, Active, not recruiting, Carrick Therapeutics Limited | Recruiting --> Active, not recruiting

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.

Although tamoxifen therapy is an essential treatment, the long-term benefit for patients with luminal A and B subtype is not well understood. Secondary analysis of 952 ER-positive/HER2-negative patients with luminal A or B molecular subtype from the Stockholm Tamoxifen 2, 3 and 5 trials randomized to receive tamoxifen therapy (tamoxifen alone or with goserelin) or control. Our findings suggest a long-term benefit from tamoxifen for most patients with less aggressive tumor characteristics irrespective of molecular subtype, but the benefit differed by menopausal status. Luminal B patients with PR-positive, lymph node-negative or low genomic risk tumors had a higher risk as compared to patients with luminal A tumors.