Patient-reported outcomes and qualitative interviews in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: results from the phase III EMBER-3 trial.
| Title: | Patient-reported outcomes and qualitative interviews in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: results from the phase III EMBER-3 trial. |
|---|---|
| Authors: | Curigliano G; Department of Oncology and Hemato-Oncology, University of Milano, Milan, Italy; European Institute of Oncology, IRCCS, Milan, Italy. Electronic address: giuseppe.curigliano@ieo.it.; O'Shaughnessy J; Baylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute, Dallas, USA.; Bidard FC; Institut Curie and University of Versailles-Saint-Quentin, Saint Cloud, France.; Casalnuovo ML; Hospital María Curie, Buenos Aires, Argentina.; Kim SB; Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.; Tokunaga E; National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.; Aftimos P; Institut Jules Bordet, Hôpital Universitaire de Bruxelles, Brussels, Belgium.; Saura C; Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.; Carey LA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, USA.; Okera M; Cancer Research SA, Adelaide, Australia.; Melo E; Hospital do Câncer de Londrina, Londrina, Brazil.; Zagouri F; Department of Clinical Therapeutics, Medical School of National and Kapodistrian University of Athens, 'Alexandra' General Hospital of Athens, Athens, Greece.; Magallanes-Maciel M; Centro Oncologico Internacional, Mexico City, Mexico.; Karadurmus N; Gülhane Education and Research Hospital, University of Health Sciences, Ankara, Turkey.; Bahadur S; Mayo Clinic Arizona, Pheonix, USA.; Speck RM; Eli Lilly and Company, Indianapolis, USA.; Wang XA; Eli Lilly and Company, Indianapolis, USA.; Pradhan K; Eli Lilly and Company, Indianapolis, USA.; Macey J; Clarivate, London, UK.; Kitchen H; Clarivate, London, UK.; Fairhurst S; Clarivate, London, UK.; Miller J; Clarivate, London, UK.; Jhaveri KL; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA.; Harbeck N; Breast Center, Department of Obstetrics and Gynecology, LMU University Hospital Munich, Munich, Germany. |
| Source: | ESMO open [ESMO Open] 2026 Apr; Vol. 11 (4), pp. 106945. Date of Electronic Publication: 2026 Apr 09. |
| Publication Type: | Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial |
| Language: | English |
| Journal Info: | Publisher: Elsevier Country of Publication: England NLM ID: 101690685 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2059-7029 (Electronic) Linking ISSN: 20597029 NLM ISO Abbreviation: ESMO Open Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2021 : [London] : Elsevier; Original Publication: London : BMJ, [2016]- |
| MeSH Terms: | Breast Neoplasms*/drug therapy ; Breast Neoplasms*/pathology ; Patient Reported Outcome Measures*; Erb-b2 Receptor Tyrosine Kinases/metabolism ; Estrogen Receptor alpha/genetics ; Fulvestrant/therapeutic use ; Receptors, Estrogen/metabolism ; Benzimidazoles/therapeutic use ; Benzimidazoles/administration & dosage ; Aminopyridines/therapeutic use ; Aminopyridines/administration & dosage ; Humans ; Female ; Middle Aged ; Adult ; Aged ; Quality of Life |
| Abstract: | Background: Imlunestrant is a next-generation, brain-penetrant, oral selective estrogen receptor degrader. In the phase III EMBER-3 trial, conducted in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer, imlunestrant demonstrated a significant progression-free survival benefit compared with standard endocrine therapy (standard of care; fulvestrant or exemestane) in patients harboring ESR1 mutations (ESR1m). Additionally, the combination of imlunestrant and abemaciclib improved outcomes compared with imlunestrant monotherapy, irrespective of ESR1m status. This manuscript reports findings from exploratory analyses of patient-reported outcome (PRO) measures and qualitative interviews evaluating EMBER-3 participants' experiences and treatment preferences.; Materials and Methods: PROs administered were the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and the PRO-Common Terminology Criteria for Adverse Events (CTCAE) items for diarrhea frequency and injection site reactions (for fulvestrant recipients only). Mean changes from baseline in EORTC QLQ-C30 scores were calculated using a longitudinal mixed model for repeated measures; a 10-point change defined as clinically meaningful. PRO-CTCAE analyses were descriptive. Interview transcripts were analyzed using directed content analysis techniques.; Results: Overall, global health status/quality of life (GHS/QoL) and function were generally maintained over time across treatment arms among the ESR1m population and all patients, with treatment differences favoring imlunestrant versus SOC among the ESR1m population. Fewer GHS/QoL and function deterioration events occurred in the imlunestrant arm (ESR1m and all patients) compared with other treatment arms. Most (72.3%) fulvestrant-treated patients reported injection site reactions at any time. Diarrhea frequency was consistently higher in the combination arm of imlunestrant-abemaciclib.; Conclusion: GHS/QoL and function were maintained across treatment arms, despite a higher incidence of diarrhea in the imlunestrant-abemaciclib group. These PRO findings complement the efficacy and safety results from EMBER-3 and further support the favorable risk-benefit profile of imlunestrant, either as oral monotherapy or in combination with abemaciclib, in patients with advanced breast cancer.; (Copyright © 2026 The Author(s). Published by Elsevier Ltd.. All rights reserved.) |
| Competing Interests: | Disclosure JM, HK, JM and SF report financial support was provided by Eli Lilly and Company. RMS, KP and XAW report a relationship with Eli Lilly and Company that includes employment and equity or stocks. GC reports a relationship with AstraZeneca Pharmaceuticals LP that includes consulting or advisory; a relationship with Bristol Myers Squibb Company, Daiichi Sankyo Inc., Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Gilead Sciences Inc., A Menarini International Pharmaceutics, Merck & Co Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., Sanofi, and Seagen Inc. that includes consulting or advisory; ESMO Open Editor-in-Chief, given his role as Editor-in-Chief, he had no involvement in the peer review of this article and had no access to information regarding its peer review, full responsibility for the editorial process for this article was delegated to another journal editor; ESMO President Elect. JOS reports a relationship with AbbVie Inc., Amgen Inc., AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb Company, Celgene Corporation, Daiichi Sankyo Inc., Eisai Inc., Eli Lilly and Company, G1 Therapeutics Inc., Genentech Inc., Genomic Health, Gilead Sciences Inc., Heron Therapeutics Inc., Ipsen Biopharm Limited, Merck & Co Inc., Novartis, Pfizer, Pierre Fabre Pharmaceuticals Inc., Sanofi, Seagen Inc., Seattle Genetics, and Stemline Therapeutics Inc. that includes consulting or advisory. FCB reports a relationship with AstraZeneca Pharmaceuticals LP, Eli Lilly and Company, Pfizer Inc., and Stemline Therapeutics Inc. that includes consulting or advisory and speaking and lecture fees; a relationship with F. Hoffmann-La Roche Ltd, and Novartis that includes consulting or advisory. PA reports a relationship with Amcure, Daiichi Sankyo Inc., F. Hoffmann-La Roche Ltd, and G1 Therapeutics Inc., Novartis Pharmaceuticals Corporation, Olema Oncology, Radius Health Inc., and Roche Diagnostics Corporation that includes consulting or advisory; a relationship with Amgen Inc., Gilead Sciences Inc., and Merck & Co Inc. that includes speaking and lecture fees. ET reports a relationship with AstraZeneca Pharmaceuticals LP, Chugai Pharmaceutical Co Ltd, Daiichi Sankyo Inc., and Eli Lilly and Company that includes speaking and lecture fees. SBK reports a relationship with AstraZeneca Pharmaceuticals LP, Daehwa Pharmaceutical Co. Ltd, Daiichi Sankyo Inc., Eli Lilly and Company, and ISU Abxis Co. Ltd that includes consulting or advisory; a relationship with Dongkook Pharmaceutical Co. Ltd, Novartis Pharmaceuticals Corporation, and Sanofi-Aventis Korea Co. Ltd that includes funding grants; a relationship with Genopeaks that includes equity or stocks. CS reports a relationship with AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb Company, Byondis B.V., Daiichi Sankyo Inc., Eisai Inc., Exact Sciences Corporation, Menarini International Foundation, Genentech Inc., Gilead Sciences Inc., GlaxoSmithKline LLC, Eli Lilly and Company, Meditech, Merck Sharp & Dohme UK Ltd, Merus, Novartis, Pfizer Inc., PharmaLex, Phillips, Pierre Fabre, Puma Biotechnology Inc., F. Hoffmann-La Roche Ltd, Seagen Inc., Synthon BV, and Zymeworks BC Inc. that includes consulting or advisory; a relationship with Boehringer Ingelheim Pharmaceuticals Inc. that includes paid expert testimony. FZ reports a relationship with AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc., Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Merck & Co Inc., Novartis Pharmaceuticals Corporation, and Pfizer that includes consulting or advisory and speaking and lecture fees. MEMM reports a relationship with AstraZeneca Pharmaceuticals LP, Pfizer, Asofarma De Mexico, and MSD Oncology that includes consulting or advisory and speaking and lecture fees; a relationship with F. Hoffmann-La Roche Ltd, and Eli Lilly and Company that includes consulting or advisory, funding grants, and speaking and lecture fees; a relationship with Novartis that includes consulting or advisory and travel reimbursement; a relationship with Amgen Inc. that includes consulting or advisory; a relationship with Bristol Myers Squibb Company that includes funding grants; a relationship with Merck & Co Inc. that includes funding grants and travel reimbursement; a relationship with Janssen Pharmaceuticals Inc. that includes travel reimbursement. KLJ reports a relationship with AbbVie Inc., Genentech Inc., Olema Pharmaceuticals, Stemline Therapeutics Inc that includes consulting or advisory; a relationship with AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc. that includes consulting or advisory, funding grants, and travel reimbursement; a relationship with Blueprint Medicines Corporation, Eisai Inc, Laboratorios Pfizer, Novartis Pharmaceuticals Corporation, Scorpion Therapeutics, Zymeworks BC Inc. that includes consulting or advisory and funding grants; a relationship with Daiichi Sankyo Inc., Eli Lilly and Company that includes consulting or advisory; a relationship with F. Hoffmann-La Roche Ltd, Merck & Co. Inc., Pfizer, Puma Biotechnology Inc., and Daiichi Sankyo Inc. that includes consulting or advisory and speaking and lecture fees. NH reports a relationship with Eli Lilly and Company, Gilead Sciences Inc., Pierre Fabre Pharmaceuticals Inc., Viatris Inc. and Zuellig Pharma that includes speaking and lecture fees; a relationship with F. Hoffmann-La Roche Ltd, Merck & Co Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., and Seagen Inc. that includes consulting or advisory and speaking and lecture fees; a relationship with Sandoz Inc. that includes consulting or advisory; co-director of West German Study Group. All other authors have declared no conflicts of interest. |
| Contributed Indexing: | Keywords: ESR1 mutations; advanced breast cancer; imlunestrant; oral selective estrogen receptor degraders (SERDs); patient-reported outcomes; quality of life |
| Substance Nomenclature: | EC 2.7.10.1 (Erb-b2 Receptor Tyrosine Kinases); 0 (Estrogen Receptor alpha); EC 2.7.10.1 (ERBB2 protein, human); 60UAB198HK (abemaciclib); 22X328QOC4 (Fulvestrant); 0 (Receptors, Estrogen); 0 (Benzimidazoles); 0 (Aminopyridines) |
| Entry Date(s): | Date Created: 20260410 Date Completed: 20260422 Latest Revision: 20260422 |
| Update Code: | 20260423 |
| PubMed Central ID: | PMC13091516 |
| DOI: | 10.1016/j.esmoop.2026.106945 |
| PMID: | 41962306 |
| Database: | MEDLINE |
Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial