TABLE 4

Recently completed and recruiting clinical trials targeting androgen, CDK4/6, and PI3K signaling in TNBC

AgentClinicaltrials.gov IdentifierPhaseMechanism of ActionStudy Arm(s)Recruitment StatusTrial Design (total n patients)Year (start–estimated study completion date)Responsible PartyListed Location CountriesReference(s)
NCT03055312IIIAR inhibitorBicalutamide vs. TPC (taxotere and xeloda, GT or gemcitabine and carboplatin)Recruiting18–70 years, female (262)December 2016–December 2020Zhong-yu Yuan, Sun Yat-sen UniversityChinaHwang et al. (2019)
BicalutamideNCT00468715IIAR inhibitorBicalutamideActive, not recruiting18–120 years, all (28)May 2007–March 2021Memorial Sloan-Kettering Cancer CenterUnited StatesGucalp et al. (2013)
NCT02353988IIAR inhibitorBicalutamide vs. physician’s choiceNot yet recruiting18–70 years, female (60)January 2015–January 2017Xiaoxiang Guan, Jinling Hospital, ChinaNot ProvidedGucalp et al. (2013)
NCT01889238IIAR inhibitorEnzaActive, not recruiting18+ years, female (118)June 2013–April 2020PfizerCanada, Italy, Spain, United Kingdom, United StatesTraina et al. (2015)
EnzaNCT02750358IIAR inhibitorEnzaActive, not recruiting18+ years, female (200)April 2016–May 2021Memorial Sloan-Kettering Cancer CenteUnited StatesLyons et al. (2018)
NCT02689427IIBAR inhibitor + antimicrotubuleEnza + paclitaxelRecruiting18+ years, all (37)February 2016–September 2020M.D. Anderson Cancer CenterUnited StatesGerratana et al. (2018)
Abiraterone acetateNCT00755885IICYP17 inhibitorAbiraterone acetateCompleted18+, female (77)September 2008–June 2016Cancer Research UKUnited KingdomGerratana et al. (2018)
NCT01842321IICYP17 inhibitorAbiraterone acetate + prednisoneActive, not recruiting18+ years, female (31)April 2013–July 2015UNICANCERFranceBonnefoi et al. (2016)
SeviteronelNCT02580448IICYP17 inhibitorSeviteronelCompleted18+ years, all (175)October 2015–January 2019Innocrin PharmaceuticalUnited StatesBardia et al. (2018); Michmerhuizen et al. (2020)
NCT02130700IICYP17 inhibitorSeviteronelCompleted18+ years, all (175)April 2014–September 2017Innocrin PharmaceuticalUnited StatesMichmerhuizen et al. (2020)
CDK4/6 + AR inhibitionNCT03090165I/IIAR inhibitor + CDK 4/6 inhibitorBicalutamide + ribociclibActive, not recruiting18+ years, all (11)March 2017–September 2022Ruth O’Regan, M.D., Big Ten Cancer Research ConsortiumUnited StatesWang et al. (2021)
NCT02605486I/IIAR inhibitor + CDK 4/6 inhibitorBicalutamide + palbociclibActive, not recruiting18+ years, female (46)November 2015–November 2022Memorial Sloan-Kettering Cancer CenterUnited States United StatesGucalp et al. (2016); Wang et al. (2021)
NCT02457910Ib/IIAR inhibitor + PI3K inhibitorEnza + taselisibActive, not recruiting18+ years, all (30)May 2015–May 7, 2020Vandana Abramson, Vanderbilt-Ingram Cancer CenterUnited StatesLehmann et al. (2020)
AR inhibitor + PI3K inhibitorNCT01884285IAR inhibitor + PI3K inhibitor+ mTOR inhibitorAZD8186 + AZD2014+ abirateroneCompleted18+ years, all (147)June 2013–March 2019AstraZenecaCanada, Spain, United Kingdom, United StatesLebert et al. (2018)
NCT03207529IAR inhibitor + PI3K inhibitorEnza + alpelisibRecruiting18+ years, all (28)June 2017–December 2020M.D. Anderson Cancer CenterUnited StatesGarrido-Castro et al. (2019)