Design of SERENA-6, a phase III switching trial of camizestrant in ESR1 -mutant breast cancer during first-line treatment
mutation ( m) is a frequent cause of acquired resistance to aromatase inhibitor (AI) plus cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i), which is a first-line therapy for hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Ca...
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| Veröffentlicht in: | Future oncology (London, England) England), 2023-03, Vol.19 (8), p.559-573 |
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| creator | Turner, Nicholas Huang-Bartlett, Cynthia Kalinsky, Kevin Cristofanilli, Massimo Bianchini, Giampaolo Chia, Stephen Iwata, Hiroji Janni, Wolfgang Ma, Cynthia X Mayer, Erica L Park, Yeon Hee Fox, Steven Liu, Xiaochun McClain, Sasha Bidard, Francois-Clement |
| description | mutation (
m) is a frequent cause of acquired resistance to aromatase inhibitor (AI) plus cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i), which is a first-line therapy for hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) that in a phase II study significantly improved progression-free survival (PFS) over fulvestrant (also a SERD) in ER+/HER2- ABC. SERENA-6 (NCT04964934) is a randomized, double-blind, phase III study evaluating the efficacy and safety of switching from an AI to camizestrant, while maintaining the same CDK4/6i, upon detection of
m in circulating tumor DNA before clinical disease progression on first-line therapy for HR+/HER2- ABC. The aim is to treat
m clones and extend the duration of control of ER-driven tumor growth, delaying the need for chemotherapy. The primary end point is PFS; secondary end points include chemotherapy-free survival, time to second progression event (PFS2), overall survival, patient-reported outcomes and safety. |
| doi_str_mv | 10.2217/fon-2022-1196 |
| format | Article |
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m) is a frequent cause of acquired resistance to aromatase inhibitor (AI) plus cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i), which is a first-line therapy for hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) that in a phase II study significantly improved progression-free survival (PFS) over fulvestrant (also a SERD) in ER+/HER2- ABC. SERENA-6 (NCT04964934) is a randomized, double-blind, phase III study evaluating the efficacy and safety of switching from an AI to camizestrant, while maintaining the same CDK4/6i, upon detection of
m in circulating tumor DNA before clinical disease progression on first-line therapy for HR+/HER2- ABC. The aim is to treat
m clones and extend the duration of control of ER-driven tumor growth, delaying the need for chemotherapy. The primary end point is PFS; secondary end points include chemotherapy-free survival, time to second progression event (PFS2), overall survival, patient-reported outcomes and safety.</description><identifier>ISSN: 1479-6694</identifier><identifier>EISSN: 1744-8301</identifier><identifier>DOI: 10.2217/fon-2022-1196</identifier><identifier>PMID: 37070653</identifier><language>eng</language><publisher>England: Future Medicine</publisher><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Aromatase Inhibitors - therapeutic use ; Breast Neoplasms - drug therapy ; Breast Neoplasms - genetics ; Breast Neoplasms - pathology ; Cancer ; Clinical Trials, Phase III as Topic ; Female ; Fulvestrant - therapeutic use ; Humans ; Life Sciences ; Randomized Controlled Trials as Topic ; Receptor, ErbB-2 - genetics ; Receptor, ErbB-2 - metabolism ; Receptors, Estrogen - metabolism</subject><ispartof>Future oncology (London, England), 2023-03, Vol.19 (8), p.559-573</ispartof><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c366t-5c1cc58b6e87f1c085c370a559e44e940165171e9e26a9640ae283253e804d973</citedby><cites>FETCH-LOGICAL-c366t-5c1cc58b6e87f1c085c370a559e44e940165171e9e26a9640ae283253e804d973</cites><orcidid>0000-0002-0586-1606 ; 0000-0001-5932-8949 ; 0000-0003-2003-2213 ; 0000-0001-5430-8957 ; 0000-0001-7070-4386 ; 0000-0002-0242-4718 ; 0000-0001-8937-0873 ; 0000-0002-4194-7175 ; 0000-0001-5911-2400 ; 0000-0002-6790-6267</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37070653$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04194824$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Turner, Nicholas</creatorcontrib><creatorcontrib>Huang-Bartlett, Cynthia</creatorcontrib><creatorcontrib>Kalinsky, Kevin</creatorcontrib><creatorcontrib>Cristofanilli, Massimo</creatorcontrib><creatorcontrib>Bianchini, Giampaolo</creatorcontrib><creatorcontrib>Chia, Stephen</creatorcontrib><creatorcontrib>Iwata, Hiroji</creatorcontrib><creatorcontrib>Janni, Wolfgang</creatorcontrib><creatorcontrib>Ma, Cynthia X</creatorcontrib><creatorcontrib>Mayer, Erica L</creatorcontrib><creatorcontrib>Park, Yeon Hee</creatorcontrib><creatorcontrib>Fox, Steven</creatorcontrib><creatorcontrib>Liu, Xiaochun</creatorcontrib><creatorcontrib>McClain, Sasha</creatorcontrib><creatorcontrib>Bidard, Francois-Clement</creatorcontrib><title>Design of SERENA-6, a phase III switching trial of camizestrant in ESR1 -mutant breast cancer during first-line treatment</title><title>Future oncology (London, England)</title><addtitle>Future Oncol</addtitle><description>mutation (
m) is a frequent cause of acquired resistance to aromatase inhibitor (AI) plus cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i), which is a first-line therapy for hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) that in a phase II study significantly improved progression-free survival (PFS) over fulvestrant (also a SERD) in ER+/HER2- ABC. SERENA-6 (NCT04964934) is a randomized, double-blind, phase III study evaluating the efficacy and safety of switching from an AI to camizestrant, while maintaining the same CDK4/6i, upon detection of
m in circulating tumor DNA before clinical disease progression on first-line therapy for HR+/HER2- ABC. The aim is to treat
m clones and extend the duration of control of ER-driven tumor growth, delaying the need for chemotherapy. The primary end point is PFS; secondary end points include chemotherapy-free survival, time to second progression event (PFS2), overall survival, patient-reported outcomes and safety.</description><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Aromatase Inhibitors - therapeutic use</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - genetics</subject><subject>Breast Neoplasms - pathology</subject><subject>Cancer</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Female</subject><subject>Fulvestrant - therapeutic use</subject><subject>Humans</subject><subject>Life Sciences</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Receptor, ErbB-2 - genetics</subject><subject>Receptor, ErbB-2 - metabolism</subject><subject>Receptors, Estrogen - metabolism</subject><issn>1479-6694</issn><issn>1744-8301</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kctvEzEQh1cIRB9w5Ip8BKkGvx_HqAQaKQKphbPlOLON0a432F5Q-evxKqUnj0ff_DSjr-veUPKBMao_9lPCjDCGKbXqWXdOtRDYcEKft1poi5Wy4qy7KOUnIUJzSV52Z1wTTZTk593DJyjxPqGpR3fr2_XXFVZXyKPjwRdAm80GlT-xhkNM96jm6IcFDH6Mf6HU7FNFMaH13S1FeJzr8t9l8KU2JgXIaD_nZbSPuVQ8xAQtBXwdIdVX3YveDwVeP76X3Y_P6-_XN3j77cvmerXFgStVsQw0BGl2CozuaSBGhra9l9KCEGAFoUpSTcECU94qQTwww5nkYIjYW80vu_en3IMf3DHH0ecHN_noblZbt_SIoFYYJn7Txr47scc8_ZrbiW6MJcAw-ATTXBwzhBljqGANxSc05KmUDP1TNiVuMeOaGbeYcYuZxr99jJ53I-yf6P8q-D9A9oa-</recordid><startdate>20230301</startdate><enddate>20230301</enddate><creator>Turner, Nicholas</creator><creator>Huang-Bartlett, Cynthia</creator><creator>Kalinsky, Kevin</creator><creator>Cristofanilli, Massimo</creator><creator>Bianchini, Giampaolo</creator><creator>Chia, Stephen</creator><creator>Iwata, Hiroji</creator><creator>Janni, Wolfgang</creator><creator>Ma, Cynthia X</creator><creator>Mayer, Erica L</creator><creator>Park, Yeon Hee</creator><creator>Fox, Steven</creator><creator>Liu, Xiaochun</creator><creator>McClain, Sasha</creator><creator>Bidard, Francois-Clement</creator><general>Future Medicine</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><orcidid>https://orcid.org/0000-0002-0586-1606</orcidid><orcidid>https://orcid.org/0000-0001-5932-8949</orcidid><orcidid>https://orcid.org/0000-0003-2003-2213</orcidid><orcidid>https://orcid.org/0000-0001-5430-8957</orcidid><orcidid>https://orcid.org/0000-0001-7070-4386</orcidid><orcidid>https://orcid.org/0000-0002-0242-4718</orcidid><orcidid>https://orcid.org/0000-0001-8937-0873</orcidid><orcidid>https://orcid.org/0000-0002-4194-7175</orcidid><orcidid>https://orcid.org/0000-0001-5911-2400</orcidid><orcidid>https://orcid.org/0000-0002-6790-6267</orcidid></search><sort><creationdate>20230301</creationdate><title>Design of SERENA-6, a phase III switching trial of camizestrant in ESR1 -mutant breast cancer during first-line treatment</title><author>Turner, Nicholas ; Huang-Bartlett, Cynthia ; Kalinsky, Kevin ; Cristofanilli, Massimo ; Bianchini, Giampaolo ; Chia, Stephen ; Iwata, Hiroji ; Janni, Wolfgang ; Ma, Cynthia X ; Mayer, Erica L ; Park, Yeon Hee ; Fox, Steven ; Liu, Xiaochun ; McClain, Sasha ; Bidard, Francois-Clement</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c366t-5c1cc58b6e87f1c085c370a559e44e940165171e9e26a9640ae283253e804d973</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Aromatase Inhibitors - therapeutic use</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - genetics</topic><topic>Breast Neoplasms - pathology</topic><topic>Cancer</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Female</topic><topic>Fulvestrant - therapeutic use</topic><topic>Humans</topic><topic>Life Sciences</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Receptor, ErbB-2 - genetics</topic><topic>Receptor, ErbB-2 - metabolism</topic><topic>Receptors, Estrogen - metabolism</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Turner, Nicholas</creatorcontrib><creatorcontrib>Huang-Bartlett, Cynthia</creatorcontrib><creatorcontrib>Kalinsky, Kevin</creatorcontrib><creatorcontrib>Cristofanilli, Massimo</creatorcontrib><creatorcontrib>Bianchini, Giampaolo</creatorcontrib><creatorcontrib>Chia, Stephen</creatorcontrib><creatorcontrib>Iwata, Hiroji</creatorcontrib><creatorcontrib>Janni, Wolfgang</creatorcontrib><creatorcontrib>Ma, Cynthia X</creatorcontrib><creatorcontrib>Mayer, Erica L</creatorcontrib><creatorcontrib>Park, Yeon Hee</creatorcontrib><creatorcontrib>Fox, Steven</creatorcontrib><creatorcontrib>Liu, Xiaochun</creatorcontrib><creatorcontrib>McClain, Sasha</creatorcontrib><creatorcontrib>Bidard, Francois-Clement</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><jtitle>Future oncology (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Turner, Nicholas</au><au>Huang-Bartlett, Cynthia</au><au>Kalinsky, Kevin</au><au>Cristofanilli, Massimo</au><au>Bianchini, Giampaolo</au><au>Chia, Stephen</au><au>Iwata, Hiroji</au><au>Janni, Wolfgang</au><au>Ma, Cynthia X</au><au>Mayer, Erica L</au><au>Park, Yeon Hee</au><au>Fox, Steven</au><au>Liu, Xiaochun</au><au>McClain, Sasha</au><au>Bidard, Francois-Clement</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Design of SERENA-6, a phase III switching trial of camizestrant in ESR1 -mutant breast cancer during first-line treatment</atitle><jtitle>Future oncology (London, England)</jtitle><addtitle>Future Oncol</addtitle><date>2023-03-01</date><risdate>2023</risdate><volume>19</volume><issue>8</issue><spage>559</spage><epage>573</epage><pages>559-573</pages><issn>1479-6694</issn><eissn>1744-8301</eissn><abstract>mutation (
m) is a frequent cause of acquired resistance to aromatase inhibitor (AI) plus cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i), which is a first-line therapy for hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) that in a phase II study significantly improved progression-free survival (PFS) over fulvestrant (also a SERD) in ER+/HER2- ABC. SERENA-6 (NCT04964934) is a randomized, double-blind, phase III study evaluating the efficacy and safety of switching from an AI to camizestrant, while maintaining the same CDK4/6i, upon detection of
m in circulating tumor DNA before clinical disease progression on first-line therapy for HR+/HER2- ABC. The aim is to treat
m clones and extend the duration of control of ER-driven tumor growth, delaying the need for chemotherapy. The primary end point is PFS; secondary end points include chemotherapy-free survival, time to second progression event (PFS2), overall survival, patient-reported outcomes and safety.</abstract><cop>England</cop><pub>Future Medicine</pub><pmid>37070653</pmid><doi>10.2217/fon-2022-1196</doi><tpages>15</tpages><orcidid>https://orcid.org/0000-0002-0586-1606</orcidid><orcidid>https://orcid.org/0000-0001-5932-8949</orcidid><orcidid>https://orcid.org/0000-0003-2003-2213</orcidid><orcidid>https://orcid.org/0000-0001-5430-8957</orcidid><orcidid>https://orcid.org/0000-0001-7070-4386</orcidid><orcidid>https://orcid.org/0000-0002-0242-4718</orcidid><orcidid>https://orcid.org/0000-0001-8937-0873</orcidid><orcidid>https://orcid.org/0000-0002-4194-7175</orcidid><orcidid>https://orcid.org/0000-0001-5911-2400</orcidid><orcidid>https://orcid.org/0000-0002-6790-6267</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1479-6694 |
| ispartof | Future oncology (London, England), 2023-03, Vol.19 (8), p.559-573 |
| issn | 1479-6694 1744-8301 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_04194824v1 |
| source | MEDLINE; PubMed Central |
| subjects | Antineoplastic Combined Chemotherapy Protocols - adverse effects Aromatase Inhibitors - therapeutic use Breast Neoplasms - drug therapy Breast Neoplasms - genetics Breast Neoplasms - pathology Cancer Clinical Trials, Phase III as Topic Female Fulvestrant - therapeutic use Humans Life Sciences Randomized Controlled Trials as Topic Receptor, ErbB-2 - genetics Receptor, ErbB-2 - metabolism Receptors, Estrogen - metabolism |
| title | Design of SERENA-6, a phase III switching trial of camizestrant in ESR1 -mutant breast cancer during first-line treatment |
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