exemestane / Generic mfg. - LARVOL DELTA

J6M-MC-JSGD: A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (clinicaltrialsregister.eu) - P2/3 | N=36 | Not yet recruiting | Sponsor: Eli Lilly & Co.

New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PIK3CA

Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy and Combined with Abemaciclib, for Patients w/ ER+, HER2- Advanced Breast Cancer (ABC), Pretreated w/ Endocrine Therapy (ET): Results of the Phase 3 EMBER-3 trial. (SABCS 2024) - P3 | "Pts were randomized 1:1:1 to imlunestrant (400 mg once daily [QD]), physician’s choice standard-of-care (SOC) ET (fulvestrant or exemestane per label), or imlunestrant (400 mg QD) + abemaciclib (150 mg twice daily). Imlunestrant significantly improved PFS vs SOC in pts with ESR1m, and imlunestrant + abemaciclib significantly improved PFS vs imlunestrant in all pts regardless of ESR1m status. Imlunestrant had a favorable safety profile alone and combined with abemaciclib, thus providing an all-oral targeted therapy option for ET-pretreated pts with ER+, HER2- ABC."

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

Patient-reported outcomes (PROs) in patients with ER+, HER2- advanced breast cancer (ABC) treated with imlunestrant, investigator's choice standard endocrine therapy, or imlunestrant + abemaciclib: Results from the phase III EMBER-3 trial. (ASCO 2025) - P3 | "The EMBER-3 trial, in patients (pts) with ER+, HER2- ABC who had disease progression on or after aromatase inhibitor-based therapy, showed significant progression free survival (PFS) improvement with imlu vs standard therapy (SOC, fulvestrant or exemestane) in pts with ESR1 mutations (ESR1m), and with imlunestrant+abemaciclib (imlu+abema) vs imlu in all pts, regardless of ESR1m. PROs from EMBER-3 demonstrated that patients with ESR1m had better GHS/QOL and PF with imlu vs SOC, mirroring efficacy results. While the frequency of CTCAE defined ISRs was low, the high rate of PRO-CTCAE ISR demonstrates that this clinically relevant adverse event is underappreciated by physicians. Additionally, all pts had generally comparable GHS/QOL and PF with imlu+abema vs imlu."

Clinical • Metastases • P3 data • Patient reported outcomes • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • ER • HER-2

Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Updated efficacy results from the phase 3 EMBER-3 trial (SABCS 2025) - "Background: At the primary progression-free survival (PFS) analysis, the phase 3 EMBER-3 trial in patients (pts) with ER+, HER2- ABC demonstrated significant PFS benefit with imlunestrant (imlu) vs standard therapy (SOC: fulvestrant or exemestane) in pts with ESR1 mutations (ESR1m), and with imlunestrant+abemaciclib (imlu+abema) vs imlu in all pts, regardless of ESR1m status. At a median follow-up of 28.5 months, a clinically meaningful improvement in OS was observed with imlu vs SOC in pts with ESR1m (corresponding to a numeric increase in mOS of 11.4 months), however, the boundary for significance was not achieved. Also, a favorable OS trend emerged with imlu+abema vs imlu in all pts, regardless of ESR1m. Sustained benefit in PFS, with clinically meaningful improvement in TTC, and PFS2 further highlight the efficacy of imlu-based regimens."

Clinical • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial (ESMO 2025) - P3 | "Randomisation was 1:1 to once-daily oral 30 mg GIRE + 10 mg E or SOC ET (exemestane/fulvestrant/tamoxifen) + E until PD or unacceptable toxicity. The safety profile of GIRE + E was manageable with no unexpected findings. GIRE + E may represent a new effective treatment option in the post-CDK4/6i setting."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer (clinicaltrials.gov) - P1/2 | N=95 | Recruiting | Sponsor: Ellipses Pharma | N=60 ➔ 95 | Trial completion date: Nov 2026 ➔ Feb 2028 | Trial primary completion date: Nov 2025 ➔ Feb 2028

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • 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 • HER-2

AZD4241, an orally bioavailable ERα PROTAC, degrades wild-type and mutant ERα and delivers anti-tumour activity in preclinical breast cancer models (AACR 2026) - "Current ER‑pathway inhibitors include aromatase inhibitors (letrozole, anastrozole, exemestane), selective estrogen receptor modulators (SERMs; tamoxifen), and selective estrogen receptor degraders (SERDs; fulvestrant, elacestrant, imlunestrant)...In vivo, AZD4241 induced dose‑dependent anti‑tumour activity and, in some cases, tumour regressions across ESR1wt and ESR1m patient‑derived xenograft (PDX) models, including a palbociclib‑resistant model...Collectively, these data confirm that AZD4241 is a potent, orally bioavailable degrader of wt and mutant ERα, driving anti-tumour efficacy in ESR1wt, ESR1m, and CDK4/6 inhibitor‑resistant PDX models. These findings support the use of AZD4241 as a novel ER-PROTAC with potential to overcome key resistance mechanisms to current standards of care and deliver clinical benefit for patients with ER‑positive breast cancer."

Preclinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CRBN • TFF1

OPERA-01: OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=510 | Recruiting | Sponsor: Olema Pharmaceuticals, Inc. | N=370 ➔ 510

Enrollment change • Monotherapy • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Longitudinal single-cell profiling of breast tumors reveals immune and epigenetic mechanisms of sensitivity and resistance to aromatase inhibitors (AACR 2026) - "Aromatase inhibitors like letrozole and exemestane play a pivotal role in the treatment algorithms for estrogen receptor (ER) positive breast cancer in all phases of the disease. Ilayda Altinönder and Villads Winton are shared first authors. Jürgen Geisler, Xavier Tekpli have jointly supervised this work."

Breast Cancer • Estrogen Receptor Positive 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

m6A-mediated control of kinase reprogramming in endocrine therapy-resistant breast cancer (AACR 2026) - "Using GLORI sequencing, a single-nucleotide-resolution method for stoichiometric m6A quantification, we profiled parental, tamoxifen and exemestane resistant MCF7 derivatives. Resistant cells also displayed selective upregulation of m6A-associated RNA-binding proteins, including YTHDF1 and IGF2BP2, consistent with a remodeled post-transcriptional landscape. Together, our findings uncover a previously underappreciated epitranscriptomic layer integrating quantitative m6A dynamics and RNA-binding protein shifts that drives kinase reprogramming and promotes ETR in breast cancer."

Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • IGF2BP2

Neoadjuvant treatment of ER-positive/HER2-negative breast cancer with aromatase inhibitors in sequence: Ki67 dynamics and biology shifts (AACR 2026) - "Patients were randomized 1:1 to NET with either letrozole or exemestane for 3 months, followed by an intrapatient cross-over to the alternative treatment for another 3 months. Our trial strongly underlines that NET involving AI as monotherapy for locally advanced HR-positive breast cancer is a pragmatic and effective alternative to NCT in highly selected patients. Ki67 expression data and MGA data at surgery turned out to be promising markers to potentially guide post-neoadjuvant decision-making and should be tested in future clinical trials."

Clinical • 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

A phase II study of androgen receptor inhibition by darolutamide in combination with leuprolide acetate and exemestane in recurrent adult-type ovarian granulosa cell tumor (SGO 2026) - No abstract available

Clinical • Combination therapy • P2 data • Oncology • Ovarian Cancer

HCC 21-208: Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Finn, Olivera, PhD | Trial completion date: Aug 2028 ➔ Mar 2029 | Trial primary completion date: Jan 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Oncology • Solid Tumor • MUC1

Combination of sirolimus, exemestane and gemcitabine in PEComa patients progressed to single agents: A case series from a referral institution (Sarcoma-RC 2026) - "Legal entity responsible for the study The authors. Funding Has not received any funding."

Clinical • Infectious Disease • Pneumonia • Rare Diseases • Respiratory Diseases • Sarcoma • Solid Tumor • PTEN • TSC1

UC-BCG-2501: NoLEEta - Phase III non-inferiority trial of chemotherapy de-escalation in hormone receptorpositive, Her2-negative, intermediate-risk early breast cancer treated with Ribociclib (LEE-011) innthe adjuvant setting (clinicaltrialsregister.eu) - P2/3 | N=3306 | Recruiting | Sponsor: Unicancer

Head-to-Head • New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Imlunestrant (Imlu) with or without abemaciclib (Abema) in advanced breast cancer (ABC): A subgroup analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients (pts) from EMBER-3 (ESMO-BC 2025) - P3 | "The EMBER-3 trial reported significant PFS improvement with imlu over standard therapy (SOC; fulvestrant [fulv] or exemestane) in pts with ESR1 mutations (m), as well as with imlu + abema over imlu in all pts, regardless of ESR1m. In pts with ER+, HER2- ABC who have progressed on prior CDK4/6i, imlu+abema showed a consistent benefit over imlu, regardless of clinico-genomic factors. EMBER-3 is the 1st phase III trial to show benefit of an oral SERD + CDK4/6i after disease progression on prior CDK4/6i."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

Clinical and biomarker subgroup analysis of evERA Breast Cancer: A Phase III trial of giredestrant plus everolimus in patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor (SABCS 2025) - P3 | "Methods Pts who had ER+, HER2- aBC with disease progression (PD) post-CDK4/6i + ET in the aBC setting, or relapse during/after CDK4/6i + ET in the adjuvant setting, were randomized 1:1 to once-daily oral 30 mg GIRE + 10 mg E or SOC ET (exemestane, fulvestrant, or tamoxifen) + E until PD or unacceptable toxicity. Conclusions GIRE + E led to clinically meaningful improvements in INV-PFS vs SOC ET + E irrespective of PIK3CAm and PIK3CA/AKT1/PTEN alt, and other key relevant subgroups, regardless of ESR1m status. These data support the use of GIRE + E vs SOC ET + E in pts with ER+, HER2- aBC post-CDK4/6i + ET."

Biomarker • Clinical • Metastases • P3 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA • PTEN

Giredestrant (GIRE), an oral selective estrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients with ER-positive, HER2-negative, advanced breast cancer (ER+, HER2– aBC) after prior treatment with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial (DKK 2026) - P3 | "Randomization: 1:1 to QD PO 30 mg GIRE + 10 mg E or SOC ET (exemestane/fulvestrant/tamoxifen) + E. Co-primary endpoints: Investigator-assessed progression-free survival (INV-PFS) in ESR1 mutation (m; centrally tested by circulating tumor DNA) and ITT populations. GIRE + E may represent a new effective treatment option in the post-CDK4/6i setting."

Clinical • Metastases • P3 data • Breast Cancer • Cardiovascular • Dental Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Stomatitis • CDK4 • ER • HER-2

Imlunestrant With or Without Abemaciclib in Advanced Breast Cancer: Safety Analyses From the Phase 3 EMBER-3 Trial (HOPA 2026) - P3 | "The EMBER-3 trial (NCT04975308) in patients with ER-positive, HER2-negative advanced breast cancer and disease progression on or after aromatase inhibitor therapy showed significant improvement in progression-free survival with imlunestrant (400 mg once daily) over standard of care (SOC; fulvestrant or exemestane) among patients with ESR1 mutations, as well as with imlunestrant (400 mg once daily) plus abemaciclib (150 mg twice daily) over imlunestrant in all patients, regardless of ESR1 mutation status.1 The detailed safety analyses are presented. Imlunestrant had a favorable safety profile, similar to SOC, with predominantly grade 1 AEs. The safety of imlunestrant plus abemaciclib was consistent with the known abemaciclib profile, without additive AEs. The AEs were manageable with supportive medications and/or dose adjustments, resulting in few treatment discontinuations in all arms."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • ER • HER-2

PADA-1: PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: UNICANCER | Not yet recruiting ➔ Recruiting

Biomarker • Circulating tumor DNA • Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2

POLAR: Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: ETOP IBCSG Partners Foundation | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

PADA-1: PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection (clinicaltrials.gov) - P3 | N=800 | Active, not recruiting | Sponsor: UNICANCER | Recruiting ➔ Active, not recruiting

Biomarker • Circulating tumor DNA • Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2

POLAR: Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer (clinicaltrials.gov) - P3 | N=405 | Active, not recruiting | Sponsor: ETOP IBCSG Partners Foundation | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2027 ➔ Jan 2029 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

PREDIX LumB: Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases (clinicaltrials.gov) - P2 | N=181 | Active, not recruiting | Sponsor: Thomas Hatschek | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2031 ➔ Dec 2031 | Trial primary completion date: Dec 2021 ➔ Jul 2021

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PGR

PADA-1: PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection (clinicaltrials.gov) - P3 | N=1017 | Active, not recruiting | Sponsor: UNICANCER | Trial completion date: Apr 2024 ➔ Jun 2025

Biomarker • Circulating tumor DNA • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2