Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/209921
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Jhaveri, Komal L. | - |
dc.contributor.author | Bellet Ezquerra, Meritxell | - |
dc.contributor.author | Turner, Nicholas C. | - |
dc.contributor.author | Loi, Sherene | - |
dc.contributor.author | Bardia, Aditya | - |
dc.contributor.author | Boni, Valentina | - |
dc.contributor.author | Sohn, Joohyuk | - |
dc.contributor.author | Neilan, Tomas G. | - |
dc.contributor.author | Villanueva Vázquez, Rafael | - |
dc.contributor.author | Kabos, Peter | - |
dc.contributor.author | García Estévez, Laura | - |
dc.contributor.author | López Miranda, Elena | - |
dc.contributor.author | Pérez Fidalgo, J. Alejandro | - |
dc.contributor.author | Pérez García, Jose M. | - |
dc.contributor.author | Yu, Jiajie | - |
dc.contributor.author | Fredrickson, Jill | - |
dc.contributor.author | Moore, Heather M. | - |
dc.contributor.author | Chang, Ching-Wei | - |
dc.contributor.author | Bond, John W. | - |
dc.contributor.author | Eng-Wong, Jennifer | - |
dc.contributor.author | Gates, Mary R. | - |
dc.contributor.author | Lim, Elgene | - |
dc.date.accessioned | 2024-04-15T08:15:55Z | - |
dc.date.available | 2024-04-15T08:15:55Z | - |
dc.date.issued | 2023-11-03 | - |
dc.identifier.issn | 1557-3265 | - |
dc.identifier.uri | http://hdl.handle.net/2445/209921 | - |
dc.description.abstract | Purpose: 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. | - |
dc.format.extent | 46 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | American Association for Cancer Research (AACR) | - |
dc.relation.isformatof | Postprint del document publicat a: https://doi.org/10.1158/1078-0432.CCR-23-1796 | - |
dc.relation.ispartof | Clinical Cancer Research, 2023, vol. 30, num. 4, p. 754-766 | - |
dc.relation.uri | https://doi.org/10.1158/1078-0432.CCR-23-1796 | - |
dc.rights | cc by-nc-nd (c) Jhaveri, Komal L. et al, 2024 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Càncer de mama | - |
dc.subject.classification | Receptors d'hormones | - |
dc.subject.classification | Quimioteràpia | - |
dc.subject.other | Breast cancer | - |
dc.subject.other | Hormone receptors | - |
dc.subject.other | Chemotherapy | - |
dc.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 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/acceptedVersion | - |
dc.date.updated | 2024-04-03T09:07:10Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 37921755 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
This item is licensed under a
Creative Commons License