A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
Reference Study ID Number: WO43919 https://forpatients.roche.com/ Kontakt: Phone: 888-662-6728 (U.S. Only) E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen
Studienlocations (3 von 198)
Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin 52074 Aachen GermanyRekrutierend» Google-MapsOnkologische Schwerpunktpraxis Bielefeld 33604 Bielefeld (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsUniversitätsklinikum Essen; Zentrum Für Frauenheilkunde 45122 Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR 79110 Freiburg (Baden-Württemberg) GermanyRekrutierend» Google-MapsNiels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH 49124 Georgsmarienhütte (Niedersachsen) GermanyRekrutierend» Google-MapsUniversitätsmedizin Göttingen Georg-August-Universität; Klinik für Gynäkologie und Geburtshilfe 37075 Göttingen (Niedersachsen) GermanyRekrutierend» Google-MapsMammazentrum Hamburg am Krankenhaus Jerusalem 20357 Hamburg (Hamburg) GermanyRekrutierend» Google-MapsMedizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie 30625 Hannover (Niedersachsen) GermanyRekrutierend» Google-MapsNationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsBrustzentrum Rhein-Ruhr Servicegesellschaft mbH 41061 Mönchengladbach (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsKlinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt 80336 München (Bayern) GermanyRekrutierend» Google-MapsSt. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise 33098 Paderborn (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsStudienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg 88212 Ravensburg (Baden-Württemberg) GermanyRekrutierend» Google-MapsBanner MD Anderson Cancer Center 85234 Gilbert United StatesRekrutierend» Google-MapsMarin Cancer Care Inc 94904 Greenbrae United StatesRekrutierend» Google-MapsCancer Blood and Specialty Clinic 90720 Los Alamitos United StatesRekrutierend» Google-MapsLos Angeles Cancer Network 90017-4803 Los Angeles United StatesRekrutierend» Google-MapsUniversity of California, Irvine Medical Center 92868 Orange United StatesRekrutierend» Google-MapsUC Davis Comprehensive Cancer Center 95817 Sacramento United StatesRekrutierend» Google-MapsRocky Mountain Cancer Centers 80220 Denver United StatesRekrutierend» Google-MapsEastern CT Hematology and Oncology Associates 06360-2740 Norwich United StatesRekrutierend» Google-MapsCancer Care Centers of Brevard 32955 Rockledge United StatesRekrutierend» Google-MapsCleveland Clinic Florida 33331 Weston United StatesRekrutierend» Google-MapsGrady Health System 30303 Atlanta United StatesRekrutierend» Google-MapsMidtown West Medical 30318 Atlanta United StatesRekrutierend» Google-MapsEmory University Hospital 30322 Atlanta United StatesRekrutierend» Google-MapsWinship Cancer Institute at Emory Saint Joseph's Hospital 30342 Atlanta United StatesRekrutierend» Google-MapsUniversity of Louisville Hospital; The James Graham Brown Cancer Center 40202 Louisville United StatesRekrutierend» Google-MapsKarmanos Cancer Institute. 48201 Detroit United StatesRekrutierend» Google-MapsCancer & Hematology Centers of Western Michigan 49503 Grand Rapids United StatesRekrutierend» Google-MapsMinnesota Oncology Hematology 55102 Saint Paul United StatesRekrutierend» Google-MapsNovant Health Presbyterain Medical Center 28204 Charlotte United StatesRekrutierend» Google-MapsNovant Health Forsyth Medical Center 27103 Winston-Salem United StatesRekrutierend» Google-MapsGabrail Cancer Center 44718 Canton United StatesRekrutierend» Google-MapsAsante Rogue Regional Medical Center 97504-8332 Medford United StatesRekrutierend» Google-MapsConsultants in Medical Oncology and Hematology 19008 Broomall United StatesZurückgezogen» Google-MapsAbramson Cancer Center Chester County Hospital; Hematology, Medical Oncology 19380 West Chester United StatesRekrutierend» Google-MapsWellSpan Oncology Research 17403 York United StatesRekrutierend» Google-MapsTexas Oncology West 79106 Amarillo United StatesRekrutierend» Google-MapsTexas Oncology - Dallas Presbyterian Hospital 75231 Dallas United StatesRekrutierend» Google-MapsTexas Tech University Health Sciences Center; Department of Internal Medicine 79905 El Paso United StatesRekrutierend» Google-MapsTexas Oncology (Flower Mound) - USOR 75028 Flower Mound United StatesRekrutierend» Google-MapsThe Center for Cancer and Blood Disorders - Fort Worth 76104 Fort Worth United StatesRekrutierend» Google-MapsLumi Research 77339 Kingwood United StatesRekrutierend» Google-MapsTexas Oncology McKinney 75071 McKinney United StatesRekrutierend» Google-MapsKadlec Clinic Hematology and Oncology 99336-7774 Kennewick United StatesRekrutierend» Google-MapsFundación CENIT para la Investigación en Neurociencias C1125ABD Buenos Aires ArgentinaRekrutierend» Google-MapsCentro Oncologico Korben; Oncology C1426AGE Ciudad Autonoma Buenos Aires ArgentinaRekrutierend» Google-MapsFundacion CORI para la Investigacion y Prevencion del Cancer F5300COE La Rioja ArgentinaAktiv, nicht rekrutierend» Google-MapsInstituto de Oncología de Rosario S2000KZE Rosario ArgentinaRekrutierend» Google-MapsSanatorio Parque S.A. S2000QGB Rosario ArgentinaRekrutierend» Google-MapsHosp Provincial D. Centenarios; Oncology Dept S2002KDS Rosario ArgentinaRekrutierend» Google-MapsCER San Juan Centro Polivalente de Asistencia e Investigacion Clinica J5400DIL San Juan ArgentinaRekrutierend» Google-MapsClinica Viedma S.A. R8500ACE Viedma ArgentinaRekrutierend» Google-MapsCampbelltown Hospital; Macarthur Cancer Therapy Centre 2560 Campbelltown AustraliaRekrutierend» Google-MapsCoffs Harbour Health Campus 2450 Coffs Harbour AustraliaRekrutierend» Google-MapsConcord Repatriation General Hospital; Concord Cancer Centre 2139 Concord AustraliaRekrutierend» Google-MapsKinghorn Cancer Centre; St Vincents Hospital 2010 Darlinghurst AustraliaRekrutierend» Google-MapsGosford Hospital; Cancer Care Services 2250 Gosford AustraliaRekrutierend» Google-MapsIcon Cancer Care Wesley 4066 Auchenflower AustraliaRekrutierend» Google-MapsUniversity of the Sunshine Coast 4556 Sippy Downs AustraliaRekrutierend» Google-MapsBendigo Cancer Centre 3550 Bendigo AustraliaRekrutierend» Google-MapsSir Charles Gairdner Hospital; Medical Oncology 6009 Perth AustraliaRekrutierend» Google-MapsCliniques Universitaires St-Luc 1200 Bruxelles BelgiumRekrutierend» Google-MapsGHdC Site Notre Dame 6000 Charleroi BelgiumRekrutierend» Google-MapsUZ Antwerpen 2650 Edegem BelgiumRekrutierend» Google-MapsUZ Gent 9000 Gent BelgiumRekrutierend» Google-MapsUZ Leuven Gasthuisberg 3000 Leuven BelgiumRekrutierend» Google-MapsClinique Ste-Elisabeth 5000 Namur BelgiumRekrutierend» Google-MapsHospital da Bahia 41810-011 Salvador BrazilRekrutierend» Google-MapsInstituto D?Or de Pesquisa e Ensino ? Hospital DF STAR 70390-140 Brasilia BrazilRekrutierend» Google-MapsNUPEC 30220-140 Belo Horizonte BrazilRekrutierend» Google-MapsHospital do Cancer de Pernambuco - HCP 50040-000 Recife BrazilRekrutierend» Google-MapsInstituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife Recife BrazilRekrutierend» Google-MapsVencer Oncoclínica - Centro de Pesquisa do Piauí 64049-200 Teresina BrazilRekrutierend» Google-MapsHospital Santa Cruz / Centro de Oncologia D'Or 80420-090 Curitiba BrazilRekrutierend» Google-MapsLiga Norte Riograndense Contra O Câncer 59040150 Natal BrazilRekrutierend» Google-MapsSanta Casa de Misericordia de Porto Alegre 90020-090 Porto Alegre BrazilRekrutierend» Google-MapsHospital Sao Lucas - PUCRS 90610-000 Porto Alegre BrazilRekrutierend» Google-MapsHospital de Base de Sao Jose do Rio Preto 15090-000 Sao Jose do Rio Preto BrazilRekrutierend» Google-MapsHospital Sírio-Libanês 01308-050 Sao Paulo BrazilRekrutierend» Google-MapsTom Baker Cancer Centre-Calgary T2N 4N2 Calgary CanadaRekrutierend» Google-MapsCross Cancer Institute T6G 1Z2 Edmonton CanadaRekrutierend» Google-MapsBC Cancer ? Vancouver V5Z 4E6 Vancouver CanadaRekrutierend» Google-MapsThe Moncton Hospital E1C 6Z8 Moncton CanadaRekrutierend» Google-MapsJuravinski Hospital L8V 1C3 Hamilton CanadaRekrutierend» Google-MapsThe Ottawa Hospital - General Campus K1H 8L6 Ottawa CanadaRekrutierend» Google-MapsCIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont H1T 2M4 Montreal CanadaRekrutierend» Google-MapsCentre Hospitalier de l'Universite de Montreal (CHUM) H2X 0C1 Montreal CanadaRekrutierend» Google-MapsJewish General Hospital H3T 1E2 Montreal CanadaRekrutierend» Google-MapsHôpital du Sacré-Coeur de Montreal H4J 1C5 Montreal CanadaRekrutierend» Google-MapsThe First Hospital of Jilin University 130021 Changchun City ChinaRekrutierend» Google-MapsSichuan Provincial Cancer Hospital 610041 Chengdu ChinaRekrutierend» Google-MapsThe First Affiliated Hospital, Chongqing Medical University 400016 Chongqing ChinaRekrutierend» Google-MapsGuangdong Provincial People's Hospital; Breast 510180 Guangzhou City ChinaRekrutierend» Google-MapsSun yat-sen University Cancer Center; Internal Medicine of Oncology 510060 Guangzhou ChinaRekrutierend» Google-MapsThe Second Affiliated Hospital of Zhejiang University School of Medicine 310009 Hangzhou City ChinaRekrutierend» Google-MapsSir Run Run Shaw Hospital Zhejiang University 310016 Hangzhou City ChinaRekrutierend» Google-MapsHarbin Medical University Tumor Hospital; Department of Surgery; Pharmacy 150049 Harbin ChinaRekrutierend» Google-MapsShandong Cancer Hospital 250117 Jinan ChinaRekrutierend» Google-MapsThe Second Affiliated Hospital to Nanchang University 330006 Nanchang ChinaRekrutierend» Google-MapsJiangsu Cancer Hospital 211100 Nanjing City ChinaRekrutierend» Google-MapsTianjin Cancer Hospital; Department of Breast Oncology 300000 Tianjin ChinaRekrutierend» Google-MapsUnion Hospital Tongji Medical College Huazhong University of Science and Technology 430023 Wuhan City ChinaRekrutierend» Google-MapsHubei Cancer Hospital 430079 Wuhan ChinaRekrutierend» Google-MapsFirst Affiliated Hospital of Medical College of Xi'an Jiaotong University 710061 Xi'an ChinaRekrutierend» Google-MapsZhejiang Cancer Hospital 310022 Zhejiang ChinaRekrutierend» Google-MapsCentre Hospitalier de La Cote Basque; Oncologie 64109 Bayonne FranceRekrutierend» Google-MapsPolyclinique Bordeaux Nord 33300 Bordeaux FranceRekrutierend» Google-MapsCentre Leon Berard; Service Oncologie Medicale 69008 Lyon FranceRekrutierend» Google-MapsICM; Medecine B3 34298 Montpellier cedex 5 FranceRekrutierend» Google-MapsIUCT Oncopole 31100 Toulouse FranceRekrutierend» Google-MapsA.O. S. Anna e San Sebastiano; Oncologia 81100 Caserta ItalyRekrutierend» Google-MapsIRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica 47014 Meldola ItalyRekrutierend» Google-MapsAUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia 48121 Ravenna ItalyRekrutierend» Google-MapsIrccs Centro Di Riferimento Oncologico (CRO) 33081 Aviano ItalyRekrutierend» Google-MapsOspedale San Raffaele; Medical Oncology 20132 Milano ItalyRekrutierend» Google-MapsASL AL - Azienda Sanitaria Locale AL; S.C. Oncologia 15121 Alessandria ItalyRekrutierend» Google-MapsAOU Città della Salute e della Scienza di Torino 10126 Torino ItalyRekrutierend» Google-MapsHumanitas Centro Catanese Di Oncologia; Oncologia Medica 95045 Misterbianco (CT) ItalyRekrutierend» Google-MapsOspedale S. Giuseppe; Oncologia 50053 Empoli (FI) ItalyRekrutierend» Google-MapsOspedale Santa Chiara; Oncologia Medica 38100 Trento ItalyRekrutierend» Google-MapsKyungpook National University Chilgok Hospital 41404 Daegu Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsNational Cancer Center 10408 Goyang-si Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsCHA Bundang Medical Center 13496 Gyeonggi-do Korea, Republic ofRekrutierend» Google-MapsCatholic Univ. of Incheon St.Mary's Hospital 21431 Incheon Korea, Republic ofRekrutierend» Google-MapsInha University Hospital 22332 Incheon Korea, Republic ofRekrutierend» Google-MapsKorea University Anam Hospital 02841 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System 03722 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsGangnam Severance Hospital 06273 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSeoul St Mary's Hospital 06591 Seoul Korea, Republic ofRekrutierend» Google-MapsAntiguo Hospital Civil de Guadalajara Fray Antonio Alcalde 44280 Guadalajara MexicoRekrutierend» Google-MapsPanamerican Clinical Research S.A de C.V. 44670 Guadalajara MexicoRekrutierend» Google-MapsRENATI INNOVATION S.A.P.I. de C.V 44680 Guadalajara MexicoRekrutierend» Google-MapsHealth Pharma Professional Research 03100 Cdmx MexicoRekrutierend» Google-MapsCOI Centro Oncologico Internacional Santa Fe 01330 Ciudad de México MexicoAktiv, nicht rekrutierend» Google-MapsOncoMed; Supportive Care 03100 Ciudad de México MexicoRekrutierend» Google-MapsARKE Estudios Clínicos S.A. de C.V. 06700 Ciudad de México MexicoRekrutierend» Google-MapsCENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO 03100 Mexico City MexicoRekrutierend» Google-MapsInstituto Nacional de Cancerologia; Oncology 14080 Mexico City MexicoRekrutierend» Google-MapsCentrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii 85-796 Bydgoszcz PolandRekrutierend» Google-MapsSzpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny 81-519 Gdynia PolandRekrutierend» Google-MapsNarodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi 44-102 Gliwice PolandRekrutierend» Google-MapsPrzychodnia Lekarska KOMED, Roman Karaszewski 62-500 Konin PolandAktiv, nicht rekrutierend» Google-MapsSzpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii 75-581 Koszalin PolandRekrutierend» Google-MapsSzpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna 31-501 Kraków PolandRekrutierend» Google-MapsMRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie 35-021 Rzeszow PolandRekrutierend» Google-MapsNarodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr 02-781 Warszawa PolandRekrutierend» Google-MapsDr. W.M. Szpak Incorporated trading as Rainbow Oncology 4126 Durban South AfricaRekrutierend» Google-MapsHopelands Cancer Centre 3245 Hilton South AfricaRekrutierend» Google-MapsMedical Oncology Centre of Rosebank; Oncology 2196 Johannesburg South AfricaRekrutierend» Google-MapsRichards Bay Oncology Centre 3900 KwaZulu Natal South AfricaRekrutierend» Google-MapsICO L'Hospitalet; Servicio de oncologia medica 08908 L'Hospitalet de Llobregat SpainRekrutierend» Google-MapsComplejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia 15706 Santiago de Compostela SpainRekrutierend» Google-MapsHospital Universitario de Canarias;servicio de Oncologia 38320 La Laguna SpainRekrutierend» Google-MapsHospital Universitari Vall d'Hebron; Oncology 08035 Barcelona SpainRekrutierend» Google-MapsHospital San Pedro De Alcantara; Servicio de Oncologia 10003 Caceres SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Marañon; Servicio de Oncologia 28007 Madrid SpainRekrutierend» Google-MapsHospital Ramon y Cajal; Servicio de Oncologia 28034 Madrid SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre; Servicio de Oncologia 28041 Madrid SpainRekrutierend» Google-MapsHospital Regional Universitario Carlos Haya; Servicio de Oncologia 29011 Malaga SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario Virgen de Arrixaca; Servicio de Oncologia 30120 Murcia SpainRekrutierend» Google-MapsHospital Universitario Virgen Macarena; Servicio de Oncologia 41009 Sevilla SpainRekrutierend» Google-MapsChina Medical University Hospital; Surgery 404 Taichung TaiwanAktiv, nicht rekrutierend» Google-MapsNational Cheng Kung University Hospital 70457 Tainan TaiwanRekrutierend» Google-MapsTaipei Veterans General Hospital 11217 Taipei City TaiwanRekrutierend» Google-MapsChang Gung Memorial Hosipital at Linkou 333 Taoyuan City TaiwanRekrutierend» Google-MapsVeterans General Hospital - Taichung 40705 Xitun Dist. TaiwanRekrutierend» Google-MapsNational Taiwan University Hospital; Oncology 10048 Zhongzheng Dist. TaiwanRekrutierend» Google-MapsChulalongkorn Hospital; Medical Oncology 10330 Bangkok ThailandRekrutierend» Google-MapsMaharaj Nakorn Chiang Mai Hospital; Department of Medicine 50200 ChiangMai ThailandRekrutierend» Google-MapsSongklanagarind Hospital; Department of Oncology 90110 Songkhla ThailandRekrutierend» Google-MapsGulhane Training and Applicaton Hospital 06010 Ankara TurkeyAktiv, nicht rekrutierend» Google-MapsMemorial Ankara Hastanesi 06520 Ankara TurkeyAktiv, nicht rekrutierend» Google-MapsDicle University Faculty of Medicine 21280 Diyarbakir TurkeyRekrutierend» Google-MapsTrakya University Medical Faculty 22030 Edirne TurkeyAktiv, nicht rekrutierend» Google-MapsMedipol Mega Üniversite Hastanesi Göztepe 34214 Istanbul TurkeyAktiv, nicht rekrutierend» Google-MapsMarmara Uni Faculty of Medicine; Medical Oncology 34890 Istanbul TurkeyAktiv, nicht rekrutierend» Google-MapsEge Uni Medical Faculty Hospital; Oncology Dept 35100 Izmir TurkeyRekrutierend» Google-MapsKatip Celebi University Ataturk Training and Research Hospital; Oncology 35360 Izmir TurkeyAktiv, nicht rekrutierend» Google-MapsGoztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology 34722 Kadiköy TurkeyAktiv, nicht rekrutierend» Google-MapsMedical Park Seyhan Hospital; Oncology Department 01140 Seyhan TurkeyRekrutierend» Google-MapsHacettepe Uni Medical Faculty Hospital; Oncology Dept 06230 Sihhiye/Ankara TurkeyAktiv, nicht rekrutierend» Google-MapsBasingstoke and North Hampshire Hospital RG24 9NA Basingstoke United KingdomRekrutierend» Google-MapsBlackpool Victoria Hospital FY3 8NR Blackpool United KingdomAktiv, nicht rekrutierend» Google-MapsDumfries and Galloway Royal Infirmary DG2 8RX Dumfries United KingdomRekrutierend» Google-MapsWestern General Hospital; Clinical Oncology EH4 2XU Edinburgh United KingdomRekrutierend» Google-MapsPrincess Alexandra Hospital CM20 1QX Harlow United KingdomAktiv, nicht rekrutierend» Google-MapsSt John's Hospital EH54 6PP Livingston United KingdomRekrutierend» Google-MapsSt Bartholomew's Hospital EC1M 6BQ London United KingdomRekrutierend» Google-MapsMaidstone & Tonbridge Wells Hospital; Kent Oncology Center ME16 9QQ Maidstone United KingdomRekrutierend» Google-MapsMount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology HA6 2RN Northwood United KingdomRekrutierend» Google-MapsChurchill Hospital; Department of Oncology OX3 7LE Oxford United KingdomAktiv, nicht rekrutierend» Google-MapsRoyal Preston Hosptial PR2 9HT Preston United KingdomRekrutierend» Google-MapsROYAL HAMPSHIRE COUNTY HOSPITAL; R&D Office SO22 5DG Winchester United KingdomRekrutierend» Google-Maps
1. Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS) (Time Frame - From randomization until disease progression or death due to any cause (up to approximately 64 months))
Secondary outcome:
1. Overall survival (OS) (Time Frame - From randomization until death due to any cause (up to approximately 85 months))
2. BICR-Assessed Overall Response Rate (ORR) (Time Frame - Up to approximately 64 months)
3. BICR-Assessed Best Overall Response (BOR) (Time Frame - Up to approximately 64 months)
4. BICR-Assessed Clinical Benefit Rate (CBR) (Time Frame - Up to approximately 64 months)
5. BICR-Assessed Duration of Response (DOR) (Time Frame - From CR or PR until disease progression or death due to any cause (up to approximately 64 months))
6. Time to Confirmed Deterioration (TTCD) in Pain (Time Frame - Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.)
7. TTCD in Physical Functioning (Time Frame - Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.)
8. TTCD in Role Functioning (Time Frame - Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.)
9. TTCD in Global Health Status/Quality of Life (QOL) (Time Frame - Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.)
10. Percentage of Participants with Adverse Events (Time Frame - Day 1 until 30 days after the final dose of study treatment (up to approximately 85 months))
11. Plasma Concentration of Inavolisib at Specified Timepoints (Time Frame - Day 1 and 15 of Cycle 1, and Day 1 of Cycles 2 and 3. Each cycle is 28 days.)
Inavolisib: Participants will be administered a 9 milligram (mg) inavolisib tablet orally once a day (PO QD) on Days 1-28 of each 28-day cycle.
Fulvestrant: Participants will be administered 500 mg of fulvestrant on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle.
Alpelisib: Alpelisib will be administered to participants at the approved dose in combination with fulvestrant: 300 mg taken PO QD and on days 1-28 of each 28-day cycle.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy"
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