Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?

The EMERALD trial was an open label phase 3 trial evaluating elacestrant, the first oral selective estrogen receptor degrader (SERD), as compared to “standard of care”, in ER+/HER2- (hormone receptor positive, no HER2 overexpression) advanced or metastatic breast cancer.The EMERALD trial restricted...

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Autores principales:	Timothée Olivier, Vinay Prasad
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2022
Materias:	Hormone sensitive breast cancer Substandard control arm Hormonotherapy Metastatic Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/4107528f9cd04a91a32dd75aa46d91c5
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id	oai:doaj.org-article:4107528f9cd04a91a32dd75aa46d91c5
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spelling	oai:doaj.org-article:4107528f9cd04a91a32dd75aa46d91c52021-11-18T04:46:27ZElacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?1936-523310.1016/j.tranon.2021.101273https://doaj.org/article/4107528f9cd04a91a32dd75aa46d91c52022-01-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S1936523321002643https://doaj.org/toc/1936-5233The EMERALD trial was an open label phase 3 trial evaluating elacestrant, the first oral selective estrogen receptor degrader (SERD), as compared to “standard of care”, in ER+/HER2- (hormone receptor positive, no HER2 overexpression) advanced or metastatic breast cancer.The EMERALD trial restricted the “standard of care” control arm to limited options that may have led to a substandard control arm. We describe how the EMERALD trial protocol allowed different clinically inappropriate scenarios in the control arm, according to prior therapy. The main relevant question remains the potential advantage of elacestrant over fulvestrant in fulvestrant-naive patients.Analyzing outcomes in subgroups according to prior and per-protocol therapy would help analyzing trial results. However, these subgroup results may be non-significant, and another randomized trial will be needed. Trials should be designed to answer directly clinical questions that are relevant.Timothée OlivierVinay PrasadElsevierarticleHormone sensitive breast cancerSubstandard control armHormonotherapyMetastaticNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENTranslational Oncology, Vol 15, Iss 1, Pp 101273- (2022)
institution	DOAJ
collection	DOAJ
language	EN
topic	Hormone sensitive breast cancer Substandard control arm Hormonotherapy Metastatic Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Hormone sensitive breast cancer Substandard control arm Hormonotherapy Metastatic Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Timothée Olivier Vinay Prasad Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?
description	The EMERALD trial was an open label phase 3 trial evaluating elacestrant, the first oral selective estrogen receptor degrader (SERD), as compared to “standard of care”, in ER+/HER2- (hormone receptor positive, no HER2 overexpression) advanced or metastatic breast cancer.The EMERALD trial restricted the “standard of care” control arm to limited options that may have led to a substandard control arm. We describe how the EMERALD trial protocol allowed different clinically inappropriate scenarios in the control arm, according to prior therapy. The main relevant question remains the potential advantage of elacestrant over fulvestrant in fulvestrant-naive patients.Analyzing outcomes in subgroups according to prior and per-protocol therapy would help analyzing trial results. However, these subgroup results may be non-significant, and another randomized trial will be needed. Trials should be designed to answer directly clinical questions that are relevant.
format	article
author	Timothée Olivier Vinay Prasad
author_facet	Timothée Olivier Vinay Prasad
author_sort	Timothée Olivier
title	Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?
title_short	Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?
title_full	Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?
title_fullStr	Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?
title_full_unstemmed	Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?
title_sort	elacestrant in metastatic breast cancer: is the “standard of care” meeting standard requirements?
publisher	Elsevier
publishDate	2022
url	https://doaj.org/article/4107528f9cd04a91a32dd75aa46d91c5
work_keys_str_mv	AT timotheeolivier elacestrantinmetastaticbreastcanceristhestandardofcaremeetingstandardrequirements AT vinayprasad elacestrantinmetastaticbreastcanceristhestandardofcaremeetingstandardrequirements
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Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?

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