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
Start Date
6/7/2023
Completion Date
3/30/2029
Summary
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.
Detailed Description
The drug-drug interaction (DDI) substudy will evaluate the impact of repeat doses of inavolisib (coadministered with fulvestrant) on single-dose pharmacokinetics of sensitive CYP450 enzyme substrates (midazolam, omeprazole and bupropion) in participants with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after CDK4/6 inhibitor (CDK4/6i) in combination with endocrine therapy (ET). Enrollment for the substudy is now open to recruitment.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Inavolisib
Fulvestrant
Alpelisib
Bupropion
Omeprazole
Midazolam
Conditions
Locations
Marin Cancer Care Inc
Greenbrae, California 94904
United States
Cancer Blood and Specialty Clinic
Los Alamitos, California 90720
United States
Los Angeles Cancer Network
Los Angeles, California 90017-4803
United States
University of California, Irvine Medical Center
Orange, California 92868
United States
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Rocky Mountain Cancer Centers
Denver, Colorado 80220
United States
Banner MD Anderson Cancer Center
Greeley, Colorado 85234
United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut 06360-2740
United States
Cancer Care Centers of Brevard
Palm Bay, Florida 32901
United States
Cleveland Clinic Florida
Weston, Florida 33331
United States
Grady Health System
Atlanta, Georgia 30303
United States
Midtown West Medical
Atlanta, Georgia 30318
United States
Emory University Hospital
Atlanta, Georgia 30322
United States
Winship Cancer Institute at Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
University of Louisville Hospital
Louisville, Kentucky 40202
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Karmanos Cancer Institute.
Detroit, Michigan 48201
United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan 49503
United States
Minnesota Oncology Hematology
Saint Paul, Minnesota 55102
United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey 08103
United States
Novant Health Presbyterain Medical Center
Charlotte, North Carolina 28204
United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
United States
Gabrail Cancer Center
Canton, Ohio 44718
United States
Asante Rogue Regional Medical Center
Medford, Oregon 97504-8332
United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010-3121
United States
St. Lukes Hospital and Health Network
Easton, Pennsylvania 18045
United States
Paoli Memorial Hospital
Paoli, Pennsylvania 19301
United States
Abramson Cancer Center Chester County Hospital
West Chester, Pennsylvania 19380
United States
Lankenau Medical Center, Cancer Center
Wynnewood, Pennsylvania 19096
United States
Main Line Health System
Wynnewood, Pennsylvania 19096
United States
WellSpan Oncology Research
York, Pennsylvania 17403
United States
Texas Oncology West
Amarillo, Texas 79106
United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas 75231
United States
Texas Tech University Health Sciences Center
El Paso, Texas 79905
United States
Texas Oncology (Flower Mound) - USOR
Flower Mound, Texas 75028
United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas 76104
United States
Lumi Research
Kingwood, Texas 77339
United States
Texas Oncology McKinney
McKinney, Texas 75071
United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336-7774
United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, C1113AAE
Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
Argentina
Fundacion CORI para la Investigacion y Prevencion del Cancer
La Rioja, F5300COE
Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE
Argentina
Sanatorio Parque S.A.
Rosario, S2000QGB
Argentina
Hosp Provincial D. Centenarios
Rosario, S2002KDS
Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, J5400DIL
Argentina
Clinica Viedma S.A.
Viedma, R8500ACE
Argentina
Campbelltown Hospital
Campbelltown, New South Wales 2560
Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales 2450
Australia
Concord Repatriation General Hospital
Concord, New South Wales 2139
Australia
Kinghorn Cancer Centre
Darlinghurst, New South Wales 2010
Australia
Gosford Hospital
Gosford, New South Wales 2250
Australia
Icon Cancer Care Wesley
Auchenflower, Queensland 4066
Australia
University of the Sunshine Coast
Sippy Downs, Queensland 4556
Australia
Bendigo Cancer Centre
Bendigo, Victoria 3550
Australia
Sir Charles Gairdner Hospital
Perth, Western Australia 6009
Australia
Cliniques Universitaires St-Luc
Brussels, 1200
Belgium
GHdC Site Les Viviers
Charleroi, 6000
Belgium
UZ Antwerpen
Edegem, 2650
Belgium
UZ Gent
Ghent, 9000
Belgium
UZ Leuven Gasthuisberg
Leuven, 3000
Belgium
Clinique Ste-Elisabeth
Namur, 5000
Belgium
Hospital da Bahia
Salvador, Estado de Bahia 41810-011
Brazil
Instituto D?Or de Pesquisa e Ensino ? Hospital DF STAR
Brasília, Federal District 70390-140
Brazil
NUPEC
Belo Horizonte, Minas Gerais 30210-090
Brazil
Hospital Santa Cruz / Centro de Oncologia D'Or
Curitiba, Paraná 80420-090
Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco 50040-000
Brazil
Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife
Recife, Pernambuco
Brazil
Vencer Oncoclínica - Centro de Pesquisa do Piauí
Teresina, Piauí 64049-200
Brazil
Liga Norte Riograndense Contra O Câncer
Natal, Rio Grande do Norte 59040150
Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul 90050-170
Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul 90610-000
Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo 15090-000
Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo 01308-050
Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta T2N 5G2
Canada
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
BC Cancer ? Vancouver
Vancouver, British Columbia V5Z 4E6
Canada
The Moncton Hospital
Moncton, New Brunswick E1C 6Z8
Canada
Juravinski Hospital
Hamilton, Ontario L8V 5C2
Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario K1Y 4E9
Canada
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
Montreal, Quebec H1T 2M4
Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0C2
Canada
Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec H4J 1C5
Canada
The First Hospital of Jilin University
Changchun, 130021
China
Sichuan Provincial Cancer Hospital
Chengdu, 610041
China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016
China
Sun yat-sen University Cancer Center
Guangzhou, 510060
China
Guangdong Provincial People's Hospital
Guangzhou, 510180
China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310009
China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, 310016
China
Harbin Medical University Tumor Hospital
Harbin, 150049
China
Shandong Cancer Hospital
Jinan, 250117
China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
China
Jiangsu Cancer Hospital
Nanjing, 211100
China
Tianjin Cancer Hospital
Tianjin, 300000
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430023
China
Hubei Cancer Hospital
Wuhan, 430079
China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061
China
Zhejiang Cancer Hospital
Zhejiang, 310022
China
Institut Sainte Catherine
Avignon, 84082
France
Centre Hospitalier de La Cote Basque
Bayonne, 64109
France
Polyclinique Bordeaux Nord
Bordeaux, 33300
France
Centre Leon Berard
Lyon, 69008
France
ICM
Montpellier, 34298
France
Centre Eugene Marquis
Rennes, 35042
France
IUCT Oncopole
Toulouse, 31100
France
Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin
Aachen, 52074
Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, 33604
Germany
Universitätsklinikum Essen
Essen, 45122
Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110
Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, 49124
Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075
Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem
Hamburg, 20357
Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, 30625
Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120
Germany
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Mönchengladbach, 41061
Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, 80336
Germany
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
Paderborn, 33098
Germany
MVZ für Hämatologie und Onkologie Ravensburg GmBH
Ravensburg, 88212
Germany
A.O. S. Anna e San Sebastiano
Caserta, Campania 81100
Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna 47014
Italy
AUSL della Romagna
Ravenna, Emilia-Romagna 48121
Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia 33081
Italy
Ospedale San Raffaele
Milan, Lombardy 20132
Italy
ASL AL - Azienda Sanitaria Locale AL
Alessandria, Piedmont 15121
Italy
AOU Città della Salute e della Scienza di Torino
Turin, Piedmont 10126
Italy
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily 95045
Italy
Ospedale Di Macerata
Province of Macerata, The Marches 62100
Italy
Ospedale Santa Chiara
Trento, Trentino-Alto Adige 38100
Italy
Ospedale S. Giuseppe
Empoli (FI), Tuscany 50053
Italy
Panamerican Clinical Research S.A de C.V.
Guadalajara, Jalisco 44670
Mexico
RENATI INNOVATION S.A.P.I. de C.V
Guadalajara, Jalisco 44680
Mexico
COI Centro Oncologico Internacional Santa Fe
Mexico City, Mexico CITY (federal District) 01330
Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District) 03100
Mexico
OncoMed
Mexico City, Mexico CITY (federal District) 03100
Mexico
ARKE Estudios Clínicos S.A. de C.V.
Mexico City, Mexico CITY (federal District) 06700
Mexico
Instituto Nacional de Cancerologia
Distrito Federal, 14080
Mexico
CENEIT Oncologicos
Mexico City, 03100
Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Morelia, 58260
Mexico
New Zealand Clinical Research - Auckland
Auckland, 1010
New Zealand
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, 85-796
Poland
Szpital Morski im.PCK
Gdynia, 81-519
Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, 44-102
Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, 62-500
Poland
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, 75-581
Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-501
Poland
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
Rzeszów, 35-021
Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
Warsaw, 02-781
Poland
Dr. W.M. Szpak Incorporated trading as Rainbow Oncology
Durban, 4126
South Africa
Hopelands Cancer Centre
Hilton, 3245
South Africa
Medical Oncology Centre of Rosebank
Johannesburg, 2196
South Africa
Richards Bay Oncology Centre
KwaZulu Natal, 3900
South Africa
Mountain View Oncology
Paarl, 7646
South Africa
Kyungpook National University Chilgok Hospital
Daegu, 41404
South Korea
National Cancer Center
Goyang-si, 10408
South Korea
CHA Bundang Medical Center
Gyeonggi-do, 13496
South Korea
Catholic Univ. of Incheon St.Mary's Hospital
Incheon, 21431
South Korea
Inha University Hospital
Incheon, 22332
South Korea
Korea University Anam Hospital
Seoul, 02841
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Gangnam Severance Hospital
Seoul, 06273
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Seoul St Mary's Hospital
Seoul, 06591
South Korea
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna 15706
Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife 38320
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital San Pedro De Alcantara
Cáceres, 10003
Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Spain
Hospital Ramon y Cajal
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29011
Spain
Hospital Universitario Virgen de Arrixaca
Murcia, 30120
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
China Medical University Hospital
Taichung, 404
Taiwan
National Cheng Kung University Hospital
Tainan, 70457
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Chang Gung Memorial Hosipital at Linkou
Taoyuan City, 333
Taiwan
Veterans General Hospital - Taichung
Xitun Dist., 40705
Taiwan
National Taiwan University Hospital
Zhongzheng Dist., 10048
Taiwan
Chulalongkorn Hospital
Bangkok, 10330
Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Thailand
Chulabhorn Hospital
Lak Si, 10210
Thailand
Songklanagarind Hospital
Songkhla, 90110
Thailand
Gulhane Training and Applicaton Hospital
Ankara, 06010
Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520
Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, 21280
Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030
Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, 34214
Turkey (Türkiye)
Marmara Uni Faculty of Medicine
Istanbul, 34890
Turkey (Türkiye)
Ege Uni Medical Faculty Hospital
Izmir, 35100
Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, 35360
Turkey (Türkiye)
Goztepe Prof.Dr. Suleyman Yalcin City Hospital
Kadiköy, 34722
Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, 01140
Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, 06230
Turkey (Türkiye)
Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA
United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR
United Kingdom
Dumfries and Galloway Royal Infirmary
Dumfries, DG1 4AP
United Kingdom
Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
Princess Alexandra Hospital
Harlow, CM20 1QX
United Kingdom
St John's Hospital
Livingston, EH54 6PP
United Kingdom
St Bartholomew's Hospital
London, EC1M 6BQ
United Kingdom
Maidstone & Tonbridge Wells Hospital
Maidstone, ME16 9QQ
United Kingdom
Mount Vernon & Watford Hospital Trust
Northwood, HA6 2RN
United Kingdom
Churchill Hospital
Oxford, OX3 7LE
United Kingdom
Royal Preston Hosptial
Preston, PR2 9HT
United Kingdom
Royal Hampshire County Hospital
Winchester, SO22 5DG
United Kingdom