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Abstract
Clinical Trials: Targeted Therapy| August 19 2024
Aditya Bardia
;
Aditya Bardia
1
University of California Los Angeles (UCLA) Health Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California.
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Javier Cortés
;
Javier Cortés
2
International Breast Cancer Center (IBCC), Pangaea Oncology, Quironsalud Group, Barcelona, Spain; and IOB Madrid, Hospital Beata Maria Ana, and Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.
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François-Clément Bidard
;
François-Clément Bidard
3
Institut Curie, Paris and Saint Cloud, France.
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Patrick Neven
;
Patrick Neven
4
Universitaire Ziekenhuizen (UZ)—Leuven Cancer Institute, Leuven, Belgium.
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José Garcia-Sáenz
;
José Garcia-Sáenz
5
Instituto de Investigación Sanitaria Hospital Clinico San Carlos (IdISSC), Madrid, Spain.
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Phillipe Aftimos
;
Phillipe Aftimos
6
Institut Jules Bordet—Université Libre de Bruxelles, Brussels, Belgium.
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Joyce O’Shaughnessy
;
Joyce O’Shaughnessy
7
Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, Texas.
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Janice Lu
;
Janice Lu
8
Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois.
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Giulia Tonini
;
Giulia Tonini
9
Menarini Group, Florence, Italy.
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Simona Scartoni
;
Simona Scartoni
9
Menarini Group, Florence, Italy.
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Alessandro Paoli
;
Alessandro Paoli
9
Menarini Group, Florence, Italy.
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Monica Binaschi
;
Monica Binaschi
9
Menarini Group, Florence, Italy.
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Tomer Wasserman
;
Tomer Wasserman
9
Menarini Group, Florence, Italy.
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Virginia Kaklamani
Virginia Kaklamani *
10
University of Texas Health Sciences Center, San Antonio, Texas.
*Corresponding Author: Virginia Kaklamani, UT Health San Antonio, 303 Regent Cir, San Antonio, TX 78231-1404. E-mail: kaklamani@uthscsa.edu
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Author & Article Information
*Corresponding Author: Virginia Kaklamani, UT Health San Antonio, 303 Regent Cir, San Antonio, TX 78231-1404. E-mail: kaklamani@uthscsa.edu
Clin Cancer Res 2024;XX:XX–XX
Bardia A, Bidard FC, Neven P, et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2− metastatic breast cancer: updated results by duration of prior CDK4/6 inhibitors in metastatic setting. Presented at: San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX. Abstract GS3-01.
Bardia A, O’Shaughnessy J, Bidard FC, et al. Elacestrant versus standard-of-care in ER+/HER2− advanced or metastatic breast cancer (mBC) with ESR1 mutation: key biomarkers and clinical subgroup analyses from the phase 3 EMERALD trial. Presented at: San Antonio Breast Cancer Symposium; December 5-9, 2023; San Antonio, TX. PS17-02.
Received: April 22 2024
Revision Received: June 24 2024
Accepted: July 30 2024
Online ISSN: 1557-3265
Print ISSN: 1078-0432
©2024 The Authors; Published by the American Association for Cancer Research
2024
American Association for Cancer Research
This open access article is distributed under the Creative Commons Attribution 4.0 International (CC BY 4.0) license.
This work is licensed under a Creative Commons Attribution 4.0 International License.
Clin Cancer Res OF1–OF11.
Article history
Received:
April 22 2024
Revision Received:
June 24 2024
Accepted:
July 30 2024
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- Proof August 19 2024
- Accepted Manuscript August 1 2024
Citation
Aditya Bardia, Javier Cortés, François-Clément Bidard, Patrick Neven, José Garcia-Sáenz, Phillipe Aftimos, Joyce O’Shaughnessy, Janice Lu, Giulia Tonini, Simona Scartoni, Alessandro Paoli, Monica Binaschi, Tomer Wasserman, Virginia Kaklamani; Elacestrant in ER+, HER2− Metastatic Breast Cancer with ESR1-Mutated Tumors: Subgroup Analyses from the Phase III EMERALD Trial by Prior Duration of Endocrine Therapy plus CDK4/6 Inhibitor and in Clinical Subgroups. Clin Cancer Res 2024; https://doi.org/10.1158/1078-0432.CCR-24-1073
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Abstract
Purpose:
Elacestrant significantly prolonged progression-free survival (PFS) with manageable safety versus standard-of-care (SOC) endocrine therapy (ET) in patients with estrogen receptor–positive (ER+), HER2− metastatic breast cancer and tumors harboring estrogen receptor 1 (ESR1) mutation following ET plus a cyclin-dependent kinase 4/6 inhibitor (ET+CDK4/6i). In patients with ESR1-mutated tumors, we evaluated the efficacy and safety of elacestrant versus SOC based on prior ET+CDK4/6i duration and in clinical subgroups with prior ET+CDK4/6i ≥12 months.
Patients and Methods:
EMERALD, an open-label phase III trial, randomly assigned patients with ER+, HER2− metastatic breast cancer who had received 1–2 prior lines of ET, mandatory CDK4/6i, and ≤1 chemotherapy to elacestrant (345 mg daily) or SOC (aromatase inhibitor or fulvestrant). PFS was assessed across subgroups in post hoc exploratory analyses without adjustment for multiple testing.
Results:
In patients with ESR1-mutated tumors and prior ET+CDK4/6i ≥12 months, the median PFS for elacestrant versus SOC was 8.6 versus 1.9 months (HR, 0.41; 95% confidence interval, 0.26–0.63). In this population, the median PFS (in months) for elacestrant versus SOC was 9.1 versus 1.9 (bone metastases), 7.3 versus 1.9 (liver and/or lung metastases), 9.0 versus 1.9 (<3 metastatic sites), 10.8 versus 1.8 (≥3 metastatic sites), 5.5 versus 1.9 (PIK3 catalytic subunit α mutation), 8.6 versus 1.9 (tumor protein p53 gene mutation), 9.0 versus 1.9 (HER2-low), 9.0 versus 1.9 (ESR1D538G-mutated tumors), and 9.0 versus 1.9 (ESR1Y537S/N-mutated tumors). Subgroup safety was consistent with the overall population.
Conclusions:
The duration of prior ET+CDK4/6i ≥12 months in metastatic breast cancer was associated with a clinically meaningful improvement in PFS for elacestrant compared with SOC and was consistent across all subgroups evaluated in patients with ER+, HER2−, ESR1-mutated tumors.
This content is only available via PDF.
©2024 The Authors; Published by the American Association for Cancer Research
2024
American Association for Cancer Research
This open access article is distributed under the Creative Commons Attribution 4.0 International (CC BY 4.0) license.
This work is licensed under a Creative Commons Attribution 4.0 International License.
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