Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer

Breast cancer; Estrogen receptor

Detalhes bibliográficos
Autores: Jhaveri, Komal, Loi, Sherene, Bardia, Aditya, Bellet Ezquerra, Meritxell, Turner, Nicholas, Boni, valentina
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/11097
Acesso em linha:https://hdl.handle.net/11351/11097
http://hdl.handle.net/11351/11097
Access Level:acceso abierto
Palavra-chave:Mama - Càncer - Tractament
Medicaments antineoplàstics - Ús terapèutic
Estrògens - Receptors
Gonadoliberina
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
CHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Hypothalamic Hormones::Pituitary Hormone-Releasing Hormones::Gonadotropin-Releasing Hormone
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Receptors, Cytoplasmic and Nuclear::Receptors, Steroid::Receptors, Estrogen
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
COMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas peptídicas::hormonas hipotalámicas::hormonas liberadoras de hormonas hipofisarias::hormona liberadora de gonadotropinas
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::receptores citoplásmicos y nucleares::receptores de esteroides::receptores de estrógenos
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oai_identifier_str oai:recercat.cat:11351/11097
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
title Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
spellingShingle Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
Jhaveri, Komal
Mama - Càncer - Tractament
Medicaments antineoplàstics - Ús terapèutic
Estrògens - Receptors
Gonadoliberina
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
CHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Hypothalamic Hormones::Pituitary Hormone-Releasing Hormones::Gonadotropin-Releasing Hormone
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Receptors, Cytoplasmic and Nuclear::Receptors, Steroid::Receptors, Estrogen
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
COMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas peptídicas::hormonas hipotalámicas::hormonas liberadoras de hormonas hipofisarias::hormona liberadora de gonadotropinas
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::receptores citoplásmicos y nucleares::receptores de esteroides::receptores de estrógenos
title_short Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
title_full Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
title_fullStr Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
title_full_unstemmed Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
title_sort Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
dc.creator.none.fl_str_mv Jhaveri, Komal
Loi, Sherene
Bardia, Aditya
Bellet Ezquerra, Meritxell
Turner, Nicholas
Boni, valentina
author Jhaveri, Komal
author_facet Jhaveri, Komal
Loi, Sherene
Bardia, Aditya
Bellet Ezquerra, Meritxell
Turner, Nicholas
Boni, valentina
author_role author
author2 Loi, Sherene
Bardia, Aditya
Bellet Ezquerra, Meritxell
Turner, Nicholas
Boni, valentina
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Jhaveri KL] Department of Medicine, Breast Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York, and Weill Cornell Medical College, New York, New York. [Bellet M] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Turner NC] Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom. [Loi S] Division of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, and The Sir Peter MacCallum Department of Medical Oncology, The University of Melbourne, Parkville, Australia. [Bardia A] Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. [Boni V] START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, HM Hospitales Sanchinarro, Madrid, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Mama - Càncer - Tractament
Medicaments antineoplàstics - Ús terapèutic
Estrògens - Receptors
Gonadoliberina
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
CHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Hypothalamic Hormones::Pituitary Hormone-Releasing Hormones::Gonadotropin-Releasing Hormone
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Receptors, Cytoplasmic and Nuclear::Receptors, Steroid::Receptors, Estrogen
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
COMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas peptídicas::hormonas hipotalámicas::hormonas liberadoras de hormonas hipofisarias::hormona liberadora de gonadotropinas
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::receptores citoplásmicos y nucleares::receptores de esteroides::receptores de estrógenos
topic Mama - Càncer - Tractament
Medicaments antineoplàstics - Ús terapèutic
Estrògens - Receptors
Gonadoliberina
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
CHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Hypothalamic Hormones::Pituitary Hormone-Releasing Hormones::Gonadotropin-Releasing Hormone
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Receptors, Cytoplasmic and Nuclear::Receptors, Steroid::Receptors, Estrogen
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
COMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas peptídicas::hormonas hipotalámicas::hormonas liberadoras de hormonas hipofisarias::hormona liberadora de gonadotropinas
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::receptores citoplásmicos y nucleares::receptores de esteroides::receptores de estrógenos
description Breast cancer; Estrogen receptor
publishDate 2024
dc.date.none.fl_str_mv 2024
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/11097
http://hdl.handle.net/11351/11097
url https://hdl.handle.net/11351/11097
http://hdl.handle.net/11351/11097
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Clinical Cancer Research;30(4)
https://doi.org/10.1158/1078-0432.CCR-23-1796
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv American Association for Cancer Research
publisher.none.fl_str_mv American Association for Cancer Research
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast CancerJhaveri, KomalLoi, ShereneBardia, AdityaBellet Ezquerra, MeritxellTurner, NicholasBoni, valentinaMama - Càncer - TractamentMedicaments antineoplàstics - Ús terapèuticEstrògens - ReceptorsGonadoliberinaANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy ProtocolsDISEASES::Neoplasms::Neoplasms by Site::Breast NeoplasmsCHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Hypothalamic Hormones::Pituitary Hormone-Releasing Hormones::Gonadotropin-Releasing HormoneCHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Receptors, Cytoplasmic and Nuclear::Receptors, Steroid::Receptors, EstrogenTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinadaENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mamaCOMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas peptídicas::hormonas hipotalámicas::hormonas liberadoras de hormonas hipofisarias::hormona liberadora de gonadotropinasCOMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::receptores citoplásmicos y nucleares::receptores de esteroides::receptores de estrógenosBreast cancer; Estrogen receptorCáncer de mama; Receptor de estrógenosCàncer de mama; Receptor d'estrògensPurpose: Giredestrant is an investigational next-generation, oral, selective estrogen receptor antagonist and degrader for the treatment of estrogen receptor–positive (ER+) breast cancer. We present the primary analysis results of the phase Ia/b GO39932 study (NCT03332797). Patients and Methods: Patients with ER+, HER2-negative locally advanced/metastatic breast cancer previously treated with endocrine therapy received single-agent giredestrant (10, 30, 90, or 250 mg), or giredestrant (100 mg) ± palbociclib 125 mg ± luteinizing hormone-releasing hormone (LHRH) agonist. Detailed cardiovascular assessment was conducted with giredestrant 100 mg. Endpoints included safety (primary), pharmacokinetics, pharmacodynamics, and efficacy. Results: As of January 28, 2021, with 175 patients enrolled, no dose-limiting toxicity was observed, and the MTD was not reached. Adverse events (AE) related to giredestrant occurred in 64.9% and 59.4% of patients in the single-agent ± LHRH agonist and giredestrant + palbociclib ± LHRH agonist cohorts, respectively (giredestrant-only–related grade 3/4 AEs were reported in 4.5% of patients across the single-agent cohorts and 3.1% of those with giredestrant + palbociclib). Dose-dependent asymptomatic bradycardia was observed, but no clinically significant changes in cardiac-related outcomes: heart rate, blood pressure, or exercise duration. Clinical benefit was observed in all cohorts (48.6% of patients in the single-agent cohort and 81.3% in the giredestrant + palbociclib ± LHRH agonist cohort), with no clear dose relationship, including in patients with ESR1-mutated tumors. Conclusions: Giredestrant was well tolerated and clinically active in patients who progressed on prior endocrine therapy. Results warrant further evaluation of giredestrant in randomized trials in early- and late-stage ER+ breast cancer.This study was funded by Genentech, Inc., South San Francisco, California. K.L. Jhaveri of Memorial Sloan Kettering Cancer Center was also funded by NIH grant P30 CA008748. We thank all the patients who participated in the study, and their families, the investigators, clinicians, and research staff at the 23 centers in five countries. S. Loi is supported by the National Breast Cancer Foundation of Australia Endowed Chair and the Breast Cancer Research Foundation, New York. Support for third-party writing assistance for this article, furnished by Laura Pérez-Pachón, on behalf of Health Interactions in London, UK, was provided by F. Hoffmann-La Roche Ltd. This work was supported by Genentech, Inc., South San Francisco, California (no grant number applicable). The funder was involved in the study design, provision of study drugs, protocol development, regulatory and ethics approvals, safety monitoring, data collection, data analysis, data interpretation, and writing of the report, in collaboration with the study authors. All authors had full access to all study data and had final responsibility for the decision to submit for publication. The publication costs of this article were defrayed in part by the payment of publication fees. Therefore, and solely to indicate this fact, this article is hereby marked “advertisement” in accordance with 18 USC section 1734.American Association for Cancer ResearchInstitut Català de la Salut[Jhaveri KL] Department of Medicine, Breast Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York, and Weill Cornell Medical College, New York, New York. [Bellet M] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Turner NC] Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom. [Loi S] Division of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, and The Sir Peter MacCallum Department of Medical Oncology, The University of Melbourne, Parkville, Australia. [Bardia A] Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. [Boni V] START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, HM Hospitales Sanchinarro, Madrid, SpainVall d'Hebron Barcelona Hospital Campus202420242024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/11097http://hdl.handle.net/11351/11097Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésClinical Cancer Research;30(4)https://doi.org/10.1158/1078-0432.CCR-23-1796Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/110972026-05-29T05:05:01Z
score 15,81155

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