Orserdu (elacestrant) / Radius, Menarini, DRI Healthcare, SciClone - LARVOL DELTA

ERADICATE: A phase Ib/II study of elacestrant plus trastuzumab deruxtecan in patients with CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer (SABCS 2025) - "We recently generated preclinical data showing that the SERD fulvestrant produces synergistic activity with the chemotherapeutic agents fluorouracil and capecitabine in ESR1-mutant HR+ breast cancer cell lines.1 We also showed that in ER+/HER2- tumors, higher HER2 expression is associated with higher ER signaling.2 The phase Ib/II ERADICATE trial will evaluate the safety and efficacy of elacestrant plus T-DXd in patients with endocrine-resistant, HER2-low or HER2-ultralow HR+/HER2- MBC. Eligible patients include women or men age ≥ 18 years with HR+/HER2-low or HER2-ultralow (by local pathology review) unresectable locally advanced or metastatic breast cancer. Serial research blood samples will be collected for circulating tumor DNA (ctDNA) analyses. ERADICATE is currently pending the start of accrual."

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Current and future use of oral selective estrogen receptor degraders (SERDs) in the management of ER-positive (ER+), HER2-negative (HER2-neg) metastatic breast cancer (mBC): A survey of 20 breast cancer research leaders (RLs) (SABCS 2025) - "Background: The Jan 2023 approval of elacestrant (E) for patients with ER+ HER2-neg mBC and an ESR1 mutation (ESR1mut) with disease progression (PD) on endocrine therapy introduced new considerations for biomarker-guided decision-making. RLs have rapidly incorporated E into the management of progressive ER+ HER2-neg ESR1mut mBC, but the decision to employ this agent appears to be heavily influenced by the global disease burden and the duration of benefit from first-line treatment. Most RLs consider the newly approved imlunestrant largely equivalent to E, and all would also consider its use in combination with abemaciclib in certain situations. Many fewer would use camizestrant for patients found to have an ESR1mut without clinical PD, but an important and significant minority believe this option should be available to select patients."

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

Liquid Biopsy-Based Molecular Profiling Using Guardant360 CDx at Progression on CDK4/6i+ET: Findings from the AGO-B CAPTOR Study (SABCS 2025) - P4 | "The AGO-B "Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients" (CAPTOR) trial (NCT05452213) is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who were treated with ribociclib and endocrine therapy...Twelve (39%) had an indication for Alpelisib due to an activating mutation in PIK3CA, nine (29%) an indication for Elacestrant based on an activating mutation in ESR1, sixteen (52%) an indication for Capivasertib due to PIK3CA, AKT1 or PTEN mutation and one patient (3%) had a ERBB2 amplification resulting in an indication for an anti-HER2 treatment...Of those, seven (41%) received treatment in accordance with ctDNA test result (29% Capivasertib, 6% Trastuzumab, 6% Elacestrant). Guardant360 CDx testing was initiated for 37 patients between December 2024 and June 2025. Of those, two were cancelled due to shipment delays and four..."

Biopsy • Liquid biopsy • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • AKT1 • BRCA1 • BRCA2 • CDK4 • ER • PIK3CA • PTEN

Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): phase 2 results from ELEVATE, an open-label, umbrella study (SABCS 2025) - " ELEVATE is evaluating elacestrant combined with everolimus, alpelisib, capivasertib, abemaciclib, ribociclib,or palbociclib to address different resistance mechanisms...PFS benefit was consistent across subgroups, including those with visceral metastases, prior fulvestrant or primary ET resistance... Elacestrant in combination shows a consistent PFS benefit irrespective of ESR1m status in pts with ER+/HER2-mBC after progressive disease on ET ± prior CDK4/6i. Elacestrant has the potential to become an ET backbone for combination strategies with targeted agents, supporting an all-oral approach that may delay the need for chemo or ADC-based regimens in this patient population. Table 1:Phase 2 mPFS, mo[95% CI] in all patients and subgroupsNR, not reached"

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA

Trends and Barriers in Biomarker Testing and Treatment Patterns in HR+/HER2- Metastatic Breast Cancer (SABCS 2025) - "Among pts with ESR1+, elacestrant use rose from 22% in 2023 to 29% in 2024 in 2L and remained steady at 26-27% in 3L. In AKT1/PTEN+ pts, capivasertib use was 6% in 2L and 11% in 3L in 2024...Timely testing was less common in smaller practices and lower-SES settings, highlighting systemic barriers to precision oncology. To close these gaps, coordinated, equity-focused strategies are needed to improve timely testing and ensure appropriate use of targeted treatments across all pts populations."

Biomarker • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • AKT1 • ER • HER-2 • PIK3CA • PTEN

Poor response to systemic therapy upon progression on cyclin dependent kinase 4/6 inhibitors in HR+ Inflammatory Breast Cancer (SABCS 2025) - "RESULTS Among N = 33 patients evaluated, upon progression on standard of care CDKI and endocrine directed therapy (ET) combinations, patients received the following therapies with median ToT (months (min-max ToT)), respectively: capecitabine (N = 7; 3 (2-5)), everolimus/ET (N = 6, 3 (1-4)), Abraxane (N = 3, 3(2-10)), Eribulin (N = 2, 2.5(2-3)), capivasertib/fulvestrant (N = 1, 6(6)), taxol (N = 1, 5(5)), elacestrant (N = 1, 3(3)), fulvestrant (N = 1, 3(3)), tamoxifen (N = 1, 1(1)), intrathecal topotecan (N = 1, 1(1)), non standard/clinical trial (N = 4, 2.5(1-4)). CONCLUSION Patients with metastatic HR+ IBC demonstrate poor response to ET and cytotoxic chemotherapies upon progression on first line standard CDKI/ET, with a disproportionately high rate of death occurring in the first line setting due to advanced disease. Given previously reported low ToT on CDKI/ET in the first line and high incidence of brain relapse in this population, clinical trial design utilizing..."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • HER-2

Therapeutic Implications of Concurrent ESR1 and PI3K Pathway Mutations in HR+/HER2- Metastatic Breast Cancer (SABCS 2025) - "Likewise, alpelisib and capivasertib improved PFS in patients with PIK3CA-mutated, HR+, HER2- advanced breast cancer who had progressed on prior endocrine therapy.Little is known about the clinical significance of concurrent ESR1 and PIK3CA mutations in breast cancer patients...However, our data uniquely demonstrates that patients with concurrent ESR1 and PIK3CA mutations, who were treated initially with PIK3CA inhibitor followed by elacestrant, had longer PFS and OS. This sequencing may offer improved outcomes, as PI3K mutations may confer a worse prognosis than ESR1 mutations. Prior studies, including EMERALD and EMBER-3, have indicated shorter PFS in patients with PI3K mutations treated with oral SERDs compared to those without PI3K pathway alterations.These findings highlight the need for future studies comparing institutional data across larger cohorts and prospective trials to better define optimal sequencing strategies for this subset of patients."

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

The use of oral selective estrogen receptor degraders (SERDs) by community-based general medical oncologists (GMOs) in ER-positive (ER+), HER2-negative (HER2-neg) metastatic breast cancer (mBC): A clinician survey of practice patterns and practical challenges (SABCS 2025) - "The 1/2023 approval of elacestrant (E) for patients with mBC and an ESR1 mutation (ESR1mut) whose disease progresses on endocrine therapy (ET) introduced new treatment considerations into a clinical situation which already had multiple approved therapeutic options...Regarding select other oral SERDs (imlunestrant, camizestrant, giredestrant), 46% of GMOs believe data are not sufficient to determine comparative efficacy...In terms of novel SERDs, many GMOs consider the newly approved imlunestrant equivalent to E and would consider its use with abemaciclib in certain circumstances. While GMOs are generally familiar with the key datasets, they are also highly motivated to learn more. GMOs have rapidly incorporated E into the management of progressive ER+ HER2-neg ESR1mut mBC. Similarities and differences in practice patterns were observed between GMOs and breast cancer research leaders (data available separately) for a number of clinical situations surveyed."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

Real World Experience of PIK3CA, AKT inhibitors, and oral SERD in patients with hormone receptor positive metastatic breast cancer (SABCS 2025) - "Result A total of 107 patients who had PIK3CA pathway alteration and received PI3CK/AKT inhibitors were identified: fulvestrant alpelisib (N=51), fulvestrant capivasertib (N=35), inavolisib (N=2), 2 or more PIK3CA/AKT inhibitors (N=11), and PIK3CA/AKT inhibitors and Elacestrant (N=8). Our study is limited by its small sample size, and we observed most patients with ESR1 and PIK3CA pathway co-mutation were able to benefit from sequential therapy of oral SERD or PIK3CA pathway inhibitors, whichever treatment comes first, and showed a favorable response to either treatment. Future effort for a multi-institutional study is planned."

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ATM • BRCA1 • CDH1 • CHEK2 • ER • PIK3CA

Real-world clinical outcomes and genomic insights for patients with PIK3CA-mutant metastatic breast cancer following progression on CDK4/6 inhibitor therapy (SABCS 2025) - "Exposures of interest included treatment with capivasertib (CAPI), alpelisib (ALP), and elacestrant. In this real-world analysis, pts with PIK3CAmut mBC and CDK4/6i progression were most frequently treated with CAPI as subsequent therapy when no ESR1mut was identified; co-mutant disease received elacestrant most often. CAPI responses may differ based upon genomic alterations in baseline ctDNA, including the presence of ESR1mut, though these exploratory findings require additional follow up for data maturity. Higher frequencies of FGFR1, CCND1, and KRAS alterations at CAPI progression warrant further testing as potential acquired resistance mediators."

Clinical • Clinical data • Metastases • Real-world • Real-world evidence • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CCND1 • ER • FGFR1 • KRAS • PIK3CA • TP53

Dauntless-1: A Phase 2 Clinical Trial to Evaluate PMD-026, a First-in-Class Pan-RSK Inhibitor, Combined with Fulvestrant to Overcome Resistance to CDK4/6 Inhibitors in Advanced or Metastatic HR+/HER2- Breast Cancer (SABCS 2025) - P1/2 | "In addition, PMD-026 inhibits the nuclear translocation of RSK2 (with no change to levels of nuclear ERα), reduces ERα transcription as a single agent equal to or better than fulvestrant or elacestrant, and synergizes with fulvestrant, oral selective estrogen receptor degraders (SERDs) or vepdegestrant to substantially inhibit tumor growth in CDK4/6i sensitive and resistant models. RSK2 is highly expressed in most front-line mBC patients receiving CDK4/6i + ET therapy. PMD-026 inhibits ER signalling and is highly synergistic with fulvestrant in preclinical studies, the translation of which into potentially meaningful clinical benefit is being explored in the Dauntless-1 study."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA • RPS6KA3 • TP53

The Menarini Group…and Stemline Therapeutics…will present updated meaningful median progression-free survival (mPFS) efficacy results from two combination regimens of the Phase 2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC) (GlobeNewswire) - "The ELEVATE data to be presented at SABCS demonstrate that elacestrant in combination with everolimus or with abemaciclib shows a consistent PFS benefit, irrespective of ESR1 mutation status in patients with ER+/HER2- mBC, who experience disease progression on endocrine therapy (ET), with or without prior exposure to CDK4/6 inhibitors. These updated results also show that the safety of the combinations are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy....Other elacestrant updates will be presented at SABCS, investigating its potential across the spectrum of breast cancer."

Clinical data • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer

ADELA: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (clinicaltrials.gov) - P3 | N=240 | Active, not recruiting | Sponsor: MedSIR | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Impact of prior fulvestrant use and endocrine therapy duration on real-world outcomes of elacestrant treatment in ER+/HER2- metastatic breast cancer (SABCS 2025) - "In this real-world cohort of pts treated with elacestrant, prior fulvestrant use did not significantly impact clinical outcomes. However, longer duration of prior ET (≥12 mo) was associated with delayed TTNT, even after adjusting for key clinical factors. These findings are consistent with a post-hoc analysis from the EMERALD trial."

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Molecular Profiling of Malignant Effusions in Advanced Breast Cancer via cfDNA and Tumor Cells Analysis: A Complementary Approach to Guide Targeted Therapy (SABCS 2025) - "ESR1 D538G was detected in two patients following palbociclib/letrozole and capecitabine treatments, respectively...In a sample harboring a PTEN deletion, sensitivity to everolimus was demonstrated, with a 60% reduction of cell viability at <0.001 µM dose. Additionally, in a sample with FGFR1 amplification, paclitaxel showed a 70% reduction of cell viability at <0.1µM. Finally, in a ERBB2 and KRAS G13D mutated case, TCs showed resistance to alpelisib, palbociclib, ribociclib, elacestrant and letrozole.Malignant effusions represent a valuable and overlooked source of tumor material for molecular diagnostics in advanced breast cancer...Malignant effusions represent a valuable and overlooked source of tumor material for molecular diagnostics in advanced breast cancer. Although cfDNA NGS and cytology show high correlation, NGS can detect tumoral content in samples that tested negative for cytology, and TCs' isolation is able to confirm malignancy even in..."

Cell-free DNA • Metastases • Tumor cell • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ARID1A • BRCA1 • ER • FGFR1 • HER-2 • KRAS • PIK3CA • PTEN • TP53

Real-world second-line treatment use and clinical outcomes in patients with HR-positive/HER2-negative metastatic breast cancer (mBC) and an ESR1 mutation (ESR1m) (SABCS 2025) - "2L treatments included ET+CDK4/6i (32.3%), elacestrant monotherapy (22.6%), PI3K/AKT/mTOR inhibitor+ET (19.0%), chemotherapy/ADC (11.9%), fulvestrant monotherapy (11.1%), or other (3.1%).In the overall population, median rwPFS was 4.8 (95% CI 4.0-5.6) months and median rwOS was 24.9 (95% CI 18.8-30.9) months; results varied by treatment (Table). In patients with ESR1m HR-positive mBC, the most common real-world 2L treatments were a rechallenge ET+CDK4/6i, elacestrant, and PI3K/AKT/mTOR inhibitor+ET. ESR1m defines a difficult-to-treat subgroup, with rwPFS outcomes highlighting the need for more effective strategies that address resistance and improve patient outcomes.NE, not evaluable."

Clinical • Clinical data • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

Hormone receptor (HR)-positive HER2 negative breast cancer patients treated with preoperative Elacestrant and PULSAR adaptive radiotherapy: a phase II study (HELP Trial) (SABCS 2025) - P2 | "Patients will then receive adjuvant endocrine therapy with or without CDK4/6 inhibitors as per standard of care and postoperative RT to the locoregional lymph nodes in case of nodal residual disease, if clinically indicated.Clinical trial identification. EU Clinical Trial Number 2025-520762-22-00; NCT Number NCT07005882"

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Real world data (RWD) outcome analysis of ESR1 mutation emergence in HR+/HER2- metastatic breast cancer through the continuum of standard of care hormonal therapy (SABCS 2025) - "18 pts went on elacestrant and 46 pts went on fulvestrant after ESR1m detection.ESR1m incidence was 33.9% overall (102/301 pts), 34.0% (69/203) in 1L and 33.7% (33/98) in 2L+ settings. Our analyses show higher ESR1m incidence is associated with reduced survival regardless of line of therapy.RWD analyses also indicate the complexity of resistance within ESR1 gene including multiple mutations or co-mutations with PIK3CA and occurrence of rare ESR1m variants. The impact of these variants on therapeutic decision-making will be investigated in future research."

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

Differential Benefit to Elacestrant in A Large Cohort of ER+ HER2- Breast Cancer: Impact of ESR1 Mutants and Prior Therapy (SABCS 2025) - "In a large cohort of patients with HR+HER2- ESR1 mutated breast cancer treated with elacestrant, a relatively common mutation of ESR1 L536 and/or multiple ESR1 mutations conferred significantly less benefit to elacestrant than other variants."

Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

(z)-endoxifen maintains erα antagonist function against esr1 mutants via inactive conformation stabilization and reversal of mutant esr1-associated transcriptional signatures (SABCS 2025) - "In this in silico modeling study, we examined the biophysical behavior and downstream transcriptional impacts of (Z)-endoxifen, an active tamoxifen metabolite, a selective estrogen receptor modulator (SERM), across ESR1 variants to further elucidate its mechanism of action and therapeutic potential. (Z)-Endoxifen demonstrates robust biophysical and functional activity against ESR1 mutations. It stabilizes inactive ERα conformations and reverses mutant-driven transcriptional programs, showing greater transcriptional breadth than next-generation SERDs like elacestrant. These findings support (Z)-endoxifen's potential as a precision therapy for ESR1-mutant ER+ MBC and justify further clinical investigation in endocrine-resistant settings."

Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • ER • GLIS2

Elacestrant alone or in combination with triptorelin in premenopausal women with ER+/HER2- early breast cancer: primary analysis from the phase 2 SOLTI-2104- PremiÈRe trial (SABCS 2025) - P2 | "Ovarian function suppression (OFS) in combination with tamoxifen or aromatase inhibitors improves disease-free survival but has limitations such as toxicity, suboptimal estrogen suppression, and poor adherence. This study provides the first evidence that ELA ± OFS elicits antiproliferative and molecular responses in premenopausal women with ER+/HER2- EBC. Both regimens had comparable and significant reductions in Ki67, CCCA, ROR-P scores, and proliferation gene expression. PremiÈRe trial support the potential role of ELA as a novel ET in this population, potentially sparing the need for OFS."

Clinical • Combination therapy • P2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Exploration of racial differences in variants of uncertain significance (VUS), ESR1 and PIK3CA mutation frequency, matched therapy use, and outcomes in metastatic breast cancer (mBC) (SABCS 2025) - "ESR1 and PIK3CA codons of interest [ESR1 ligand binding domain (LBDmut); PIK3CA helical or kinase domains (HKmut)], targeted therapy matching (elacestrant and alpelisib), and outcomes were evaluated by race. In this large, rw analysis of a diverse patient population, differences in VUS rate, ESR1/PIK3CA matched therapy use, and outcomes were not observed between Black/White pts, suggesting the need for additional exploration of race-based differences on mBC outcomes. This study underscores the need for continued inclusion of diverse populations in genomic discovery and prospective studies to clarify known outcome disparities."

Metastases • Breast Cancer • Oncology • Solid Tumor • ER • PIK3CA

Elegant: elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study (SABCS 2025) - P3 | "Design and ELEGANT (NCT06492616) is a global, multicenter, open-label phase 3 study designed to evaluate elacestrant vs SOC ET (AI or tamoxifen) in patients with eBC and a high risk of recurrence. The primary endpoint is IBCFS. Key secondary endpoints include distant relapse-free survival, overall survival, invasive disease-free survival, safety, patient-reported outcomes-quality of life, and pharmacokinetics.Status: Planned enrollment is 4,220 patients; recruitment is ongoing."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Initial results from RECAST DCIS: Multicenter platform trial testing active surveillance and novel endocrine therapy agents for DCIS management (SABCS 2025) - "Patients with hormone receptor positive DCIS of any grade undergo baseline breast MRI and are randomized to one of four hormonal therapy regimens, including standard endocrine therapy, z-endoxifen, elacestrant or HAV-008 with the potential to offer equivalent or improved benefit with less adverse effects...Robust accrual continues at sixteen currently active sites with five more sites anticipated to open in the next few months.The shift to using hormonal therapy in the neoadjuvant setting allows investigators to assess response to endocrine therapy, characterize risk of progression to invasive cancer and helps to better inform treatment-making decisions before continuing AS or proceeding with surgery, and appropriately assesses the value of endocrine risk reduction prior to surgery to avoid it. The trial uses a patient-centered approach and gives all patients a window of opportunity to assess their response as well as medication tolerability to make an informed decision..."

Clinical • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer

Esr1 mutations and use of the oral serd elacestrant in metastatic breast cancer patients in austria: results from the agmt_mbc-registry (SABCS 2025) - "Four of these patients were treated with a PI3-kinase inhibitor, and one received elacestrant in combination with alpelisib. This real-world data highlights the clinical relevance of ESR1 mutations in HR+/HER2- metastatic breast cancer patients and underscores the potential impact of molecular-guided treatment. The association of ESR1 mutations with co-mutations in PIK3CA, TP53, and BRCA2 suggests the need for personalized treatment approaches. Further follow-up and outcome data will provide more insights into the long-term efficacy of elacestrant in this cohort."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • ER • HER-2 • PIK3CA • TP53