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 (INAVO121)
August 28, 2026 updated by: Hoffmann-La Roche
A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
420
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Study Contact Backup
- Name: Reference Study ID Number: WO43919 https://forpatients.roche.com/ No attachments to email below
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
-
-
-
Buenos Aires, Argentina, C1113AAE
- Completed
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L
-
Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
- Active, not recruiting
- Centro Oncologico Korben
-
La Rioja, Argentina, F5300COE
- Completed
- Fundacion CORI para la Investigacion y Prevencion del Cancer
-
Rosario, Argentina, S2000KZE
- Active, not recruiting
- Instituto de Oncologia de Rosario
-
Rosario, Argentina, S2000QGB
- Withdrawn
- Sanatorio Parque S.A.
-
Rosario, Argentina, S2002KDS
- Active, not recruiting
- Hosp Provincial D. Centenarios
-
San Juan, Argentina, J5400DIL
- Completed
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
-
Viedma, Argentina, R8500ACE
- Completed
- Clinica Viedma S.A.
-
-
-
-
New South Wales
-
Campbelltown, New South Wales, Australia, 2560
- Withdrawn
- Campbelltown Hospital
-
Coffs Harbour, New South Wales, Australia, 2450
- Active, not recruiting
- Coffs Harbour Health Campus
-
Concord, New South Wales, Australia, 2139
- Active, not recruiting
- Concord Repatriation General Hospital
-
Darlinghurst, New South Wales, Australia, 2010
- Active, not recruiting
- Kinghorn Cancer Centre
-
Gosford, New South Wales, Australia, 2250
- Completed
- Gosford Hospital
-
-
Queensland
-
Auchenflower, Queensland, Australia, 4066
- Completed
- Icon Cancer Care Wesley
-
Sippy Downs, Queensland, Australia, 4556
- Withdrawn
- University of the Sunshine Coast
-
-
Victoria
-
Bendigo, Victoria, Australia, 3550
- Active, not recruiting
- Bendigo Cancer Centre
-
-
Western Australia
-
Perth, Western Australia, Australia, 6009
- Active, not recruiting
- Sir Charles Gairdner Hospital
-
-
-
-
-
Brussels, Belgium, 1200
- Active, not recruiting
- Cliniques Universitaires St-Luc
-
Charleroi, Belgium, 6000
- Completed
- GHdC Site Les Viviers
-
Edegem, Belgium, 2650
- Completed
- UZ Antwerpen
-
Ghent, Belgium, 9000
- Active, not recruiting
- UZ Gent
-
Leuven, Belgium, 3000
- Active, not recruiting
- UZ Leuven Gasthuisberg
-
Namur, Belgium, 5000
- Active, not recruiting
- Clinique Ste-Elisabeth
-
-
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, Brazil, 41810-011
- Withdrawn
- Hospital Da Bahia
-
-
Federal District
-
Brasília, Federal District, Brazil, 70390-140
- Withdrawn
- Instituto D?Or de Pesquisa e Ensino ? Hospital DF STAR
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30210-090
- Completed
- NUPEC
-
-
Paraná
-
Curitiba, Paraná, Brazil, 80420-090
- Recruiting
- Hospital Santa Cruz / Centro de Oncologia D'Or
-
-
Pernambuco
-
Recife, Pernambuco, Brazil
- Active, not recruiting
- Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife
-
Recife, Pernambuco, Brazil, 50040-000
- Completed
- Hospital do Cancer de Pernambuco - HCP
-
-
Piauí
-
Teresina, Piauí, Brazil, 64049-200
- Withdrawn
- Vencer Oncoclínica - Centro de Pesquisa do Piauí
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brazil, 59040150
- Completed
- Liga Norte Riograndense Contra o Câncer
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
- Active, not recruiting
- Santa Casa de Misericordia de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Withdrawn
- Hospital Sao Lucas - PUCRS
-
-
São Paulo
-
São José do Rio Preto, São Paulo, Brazil, 15090-000
- Recruiting
- Hospital de Base de Sao Jose do Rio Preto
-
São Paulo, São Paulo, Brazil, 01308-050
- Active, not recruiting
- Hospital Sirio-Libanes
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 5G2
- Active, not recruiting
- Arthur J.E. Child Comprehensive Cancer Center-Calgary
-
Edmonton, Alberta, Canada, T6G 1Z2
- Active, not recruiting
- Cross Cancer Institute
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 4E6
- Completed
- BC Cancer ? Vancouver
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1C 6Z8
- Active, not recruiting
- The Moncton Hospital
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Completed
- Juravinski Hospital
-
Ottawa, Ontario, Canada, K1Y 4E9
- Active, not recruiting
- The Ottawa Hospital - General Campus
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Completed
- Jewish General Hospital
-
Montreal, Quebec, Canada, H2X 0C2
- Completed
- Centre Hospitalier de l'Université de Montréal (CHUM)
-
Montreal, Quebec, Canada, H4J 1C5
- Completed
- Hopital Du Sacre-Coeur de Montreal
-
Montreal, Quebec, Canada, H1T 2M4
- Completed
- CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
-
-
-
-
-
Changchun, China, 130021
- Completed
- The First Hospital of Jilin University
-
Chengdu, China, 610041
- Completed
- Sichuan Provincial Cancer Hospital
-
Chongqing, China, 400016
- Withdrawn
- The First Affiliated Hospital, Chongqing Medical University
-
Guangzhou, China, 510060
- Completed
- Sun Yat-sen University Cancer Center
-
Guangzhou, China, 510180
- Active, not recruiting
- Guangdong Provincial People's Hospital
-
Hangzhou, China, 310009
- Completed
- The Second Affiliated hospital of Zhejiang University school of medicine
-
Hangzhou, China, 310016
- Completed
- Sir Run Run Shaw Hospital Zhejiang University
-
Harbin, China, 150049
- Completed
- Harbin Medical University Tumor Hospital
-
Jinan, China, 250117
- Withdrawn
- Shandong Cancer Hospital
-
Nanchang, China, 330006
- Active, not recruiting
- The Second Affiliated Hospital to Nanchang University
-
Nanjing, China, 211100
- Active, not recruiting
- Jiangsu Cancer Hospital
-
Tianjin, China, 300000
- Active, not recruiting
- Tianjin Cancer Hospital
-
Wuhan, China, 430079
- Active, not recruiting
- Hubei Cancer Hospital
-
Wuhan, China, 430023
- Completed
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
Xi'an, China, 710061
- Active, not recruiting
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
-
Zhejiang, China, 310022
- Active, not recruiting
- Zhejiang Cancer Hospital
-
-
-
-
-
Avignon, France, 84082
- Withdrawn
- Institut Sainte Catherine
-
Bayonne, France, 64109
- Active, not recruiting
- Centre Hospitalier de la côte Basque
-
Bordeaux, France, 33300
- Withdrawn
- Polyclinique Bordeaux Nord
-
Lyon, France, 69008
- Active, not recruiting
- Centre Léon Bérard
-
Montpellier, France, 34298
- Active, not recruiting
- ICM
-
Rennes, France, 35042
- Active, not recruiting
- Centre Eugène Marquis
-
Toulouse, France, 31100
- Active, not recruiting
- IUCT Oncopole
-
-
-
-
-
Aachen, Germany, 52074
- Completed
- Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin
-
Bielefeld, Germany, 33604
- Withdrawn
- Onkologische Schwerpunktpraxis Bielefeld
-
Essen, Germany, 45122
- Active, not recruiting
- Universitätsklinikum Essen
-
Freiburg im Breisgau, Germany, 79110
- Active, not recruiting
- Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
-
Georgsmarienhütte, Germany, 49124
- Withdrawn
- Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
-
Göttingen, Germany, 37075
- Completed
- Universitätsmedizin Göttingen Georg-August-Universität
-
Hamburg, Germany, 20357
- Active, not recruiting
- Mammazentrum Hamburg am Krankenhaus Jerusalem
-
Hanover, Germany, 30625
- Active, not recruiting
- Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
-
Heidelberg, Germany, 69120
- Completed
- Nationales Centrum Fur Tumorerkrankungen (Nct)
-
Mönchengladbach, Germany, 41061
- Active, not recruiting
- Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
-
München, Germany, 80336
- Withdrawn
- Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
-
Paderborn, Germany, 33098
- Active, not recruiting
- St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
-
Ravensburg, Germany, 88212
- Withdrawn
- MVZ für Hämatologie und Onkologie Ravensburg GmBH
-
-
-
-
Campania
-
Caserta, Campania, Italy, 81100
- Active, not recruiting
- A.O. S. Anna e San Sebastiano
-
-
Emilia-Romagna
-
Meldola, Emilia-Romagna, Italy, 47014
- Active, not recruiting
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
-
Ravenna, Emilia-Romagna, Italy, 48121
- Withdrawn
- AUSL della Romagna
-
-
Friuli Venezia Giulia
-
Aviano, Friuli Venezia Giulia, Italy, 33081
- Withdrawn
- Irccs Centro Di Riferimento Oncologico (CRO)
-
-
Lombardy
-
Milan, Lombardy, Italy, 20132
- Active, not recruiting
- Ospedale San Raffaele
-
-
Piedmont
-
Alessandria, Piedmont, Italy, 15121
- Withdrawn
- ASL AL - Azienda Sanitaria Locale AL
-
Turin, Piedmont, Italy, 10126
- Withdrawn
- AOU Città della Salute e della Scienza di Torino
-
-
Sicily
-
Misterbianco (CT), Sicily, Italy, 95045
- Withdrawn
- Humanitas Centro Catanese Di Oncologia
-
-
The Marches
-
Province of Macerata, The Marches, Italy, 62100
- Withdrawn
- Ospedale Di Macerata
-
-
Trentino-Alto Adige
-
Trento, Trentino-Alto Adige, Italy, 38100
- Completed
- Ospedale Santa Chiara
-
-
Tuscany
-
Empoli (FI), Tuscany, Italy, 50053
- Withdrawn
- Ospedale S. Giuseppe
-
-
-
-
-
Distrito Federal, Mexico, 14080
- Completed
- Instituto Nacional De Cancerologia
-
Mexico City, Mexico, 03100
- Completed
- CENEIT Oncologicos
-
Morelia, Mexico, 58260
- Active, not recruiting
- Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44670
- Active, not recruiting
- Panamerican Clinical Research S.A de C.V.
-
Guadalajara, Jalisco, Mexico, 44680
- Completed
- RENATI INNOVATION S.A.P.I. de C.V
-
-
Mexico CITY (federal District)
-
Mexico City, Mexico CITY (federal District), Mexico, 06700
- Active, not recruiting
- ARKE Estudios Clínicos S.A. de C.V.
-
Mexico City, Mexico CITY (federal District), Mexico, 03100
- Completed
- Health Pharma Professional Research
-
Mexico City, Mexico CITY (federal District), Mexico, 03100
- Active, not recruiting
- Oncomed
-
Mexico City, Mexico CITY (federal District), Mexico, 01330
- Completed
- COI Centro Oncologico Internacional Santa Fe
-
-
-
-
-
Auckland, New Zealand, 1010
- Recruiting
- New Zealand Clinical Research - Auckland
-
-
-
-
-
Bydgoszcz, Poland, 85-796
- Completed
- Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
-
Gdynia, Poland, 81-519
- Withdrawn
- Szpital Morski im.PCK
-
Gliwice, Poland, 44-102
- Active, not recruiting
- Narodowy Instytut Onkologii Odzia? w Gliwicach
-
Konin, Poland, 62-500
- Completed
- Przychodnia Lekarska KOMED, Roman Karaszewski
-
Koszalin, Poland, 75-581
- Active, not recruiting
- Szpital Wojewódzki im. Miko?aja Kopernika
-
Krakow, Poland, 31-501
- Active, not recruiting
- Szpital Uniwersytecki w Krakowie
-
Rzeszów, Poland, 35-021
- Active, not recruiting
- MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
-
Warsaw, Poland, 02-781
- Active, not recruiting
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
-
-
-
-
-
Durban, South Africa, 4126
- Withdrawn
- Dr. W.M. Szpak Incorporated trading as Rainbow Oncology
-
Hilton, South Africa, 3245
- Withdrawn
- Hopelands Cancer Centre
-
Johannesburg, South Africa, 2196
- Completed
- Medical Oncology Centre of Rosebank
-
KwaZulu Natal, South Africa, 3900
- Completed
- Richards Bay Oncology Centre
-
Paarl, South Africa, 7646
- Withdrawn
- Mountain View Oncology
-
-
-
-
-
Daegu, South Korea, 41404
- Completed
- Kyungpook National University Chilgok Hospital
-
Goyang-si, South Korea, 10408
- Active, not recruiting
- National Cancer Center
-
Gyeonggi-do, South Korea, 13496
- Withdrawn
- CHA Bundang Medical Center
-
Incheon, South Korea, 22332
- Withdrawn
- Inha University Hospital
-
Incheon, South Korea, 21431
- Withdrawn
- Catholic Univ. of Incheon St.Mary's Hospital
-
Seoul, South Korea, 02841
- Active, not recruiting
- Korea University Anam Hospital
-
Seoul, South Korea, 03080
- Active, not recruiting
- Seoul National University Hospital
-
Seoul, South Korea, 06351
- Active, not recruiting
- Samsung Medical Center
-
Seoul, South Korea, 05505
- Active, not recruiting
- Asan Medical Center
-
Seoul, South Korea, 06591
- Active, not recruiting
- Seoul St Mary's Hospital
-
Seoul, South Korea, 03722
- Active, not recruiting
- Severance Hospital, Yonsei University Health System
-
Seoul, South Korea, 06273
- Active, not recruiting
- Gangnam Severance Hospital
-
-
-
-
-
Barcelona, Spain, 08035
- Withdrawn
- Hospital Universitari Vall d'Hebron
-
Cáceres, Spain, 10003
- Completed
- Hospital San Pedro de Alcántara
-
Madrid, Spain, 28041
- Active, not recruiting
- Hospital Universitario 12 De Octubre
-
Madrid, Spain, 28007
- Active, not recruiting
- Hospital General Universitario Gregorio Maranon
-
Madrid, Spain, 28034
- Active, not recruiting
- Hospital Ramón y Cajal
-
Murcia, Spain, 30120
- Withdrawn
- Hospital Universitario Virgen de Arrixaca
-
Málaga, Spain, 29011
- Completed
- Hospital Regional Universitario Carlos Haya
-
Seville, Spain, 41009
- Active, not recruiting
- Hospital Universitario Virgen Macarena
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
- Active, not recruiting
- ICO l'Hospitalet
-
-
LA Coruna
-
Santiago de Compostela, LA Coruna, Spain, 15706
- Withdrawn
- Complejo Hospitalario Universitario de Santiago (CHUS)
-
-
Tenerife
-
San Cristóbal de La Laguna, Tenerife, Spain, 38320
- Active, not recruiting
- Hospital Universitario de Canarias
-
-
-
-
-
Taichung, Taiwan, 404
- Active, not recruiting
- China Medical University Hospital
-
Tainan, Taiwan, 70457
- Active, not recruiting
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 11217
- Completed
- Taipei Veterans General Hospital
-
Taoyuan City, Taiwan, 333
- Completed
- Chang Gung Memorial Hosipital at Linkou
-
Xitun Dist., Taiwan, 40705
- Active, not recruiting
- Veterans General Hospital - Taichung
-
Zhongzheng Dist., Taiwan, 10048
- Active, not recruiting
- National Taiwan University Hospital
-
-
-
-
-
Bangkok, Thailand, 10330
- Withdrawn
- Chulalongkorn Hospital
-
Chiang Mai, Thailand, 50200
- Withdrawn
- Maharaj Nakorn Chiang Mai Hospital
-
Lak Si, Thailand, 10210
- Withdrawn
- Chulabhorn Hospital
-
Songkhla, Thailand, 90110
- Withdrawn
- Songklanagarind hospital
-
-
-
-
-
Ankara, Turkey (Türkiye), 06010
- Active, not recruiting
- Gulhane Training and Applicaton Hospital
-
Ankara, Turkey (Türkiye), 06520
- Active, not recruiting
- Memorial Ankara Hastanesi
-
Diyarbakır, Turkey (Türkiye), 21280
- Completed
- Dicle University Faculty of Medicine
-
Edirne, Turkey (Türkiye), 22030
- Active, not recruiting
- Trakya University Medical Faculty
-
Istanbul, Turkey (Türkiye), 34214
- Completed
- Medipol Mega Üniversite Hastanesi Göztepe
-
Istanbul, Turkey (Türkiye), 34890
- Completed
- Marmara Uni Faculty of Medicine
-
Izmir, Turkey (Türkiye), 35360
- Active, not recruiting
- Izmir Atatürk Training and Research Hospital
-
Izmir, Turkey (Türkiye), 35100
- Active, not recruiting
- Ege Uni Medical Faculty Hospital
-
Kadiköy, Turkey (Türkiye), 34722
- Completed
- Goztepe Prof.Dr. Suleyman Yalcin City Hospital
-
Seyhan, Turkey (Türkiye), 01140
- Withdrawn
- Medical Park Seyhan Hospital
-
Sihhiye/Ankara, Turkey (Türkiye), 06230
- Active, not recruiting
- Hacettepe Uni Medical Faculty Hospital
-
-
-
-
-
Basingstoke, United Kingdom, RG24 9NA
- Withdrawn
- Basingstoke and North Hampshire Hospital
-
Blackpool, United Kingdom, FY3 8NR
- Active, not recruiting
- Blackpool Victoria Hospital
-
Dumfries, United Kingdom, DG1 4AP
- Withdrawn
- Dumfries and Galloway Royal Infirmary
-
Edinburgh, United Kingdom, EH4 2XU
- Active, not recruiting
- Western General Hospital
-
Harlow, United Kingdom, CM20 1QX
- Active, not recruiting
- Princess Alexandra Hospital
-
Livingston, United Kingdom, EH54 6PP
- Withdrawn
- St John's Hospital
-
London, United Kingdom, EC1M 6BQ
- Completed
- St Bartholomew's Hospital
-
Maidstone, United Kingdom, ME16 9QQ
- Completed
- Maidstone & Tonbridge Wells Hospital
-
Northwood, United Kingdom, HA6 2RN
- Active, not recruiting
- Mount Vernon & Watford Hospital Trust
-
Oxford, United Kingdom, OX3 7LE
- Active, not recruiting
- Churchill Hospital
-
Preston, United Kingdom, PR2 9HT
- Withdrawn
- Royal Preston Hosptial
-
Winchester, United Kingdom, SO22 5DG
- Withdrawn
- Royal Hampshire County Hospital
-
-
-
-
California
-
Greenbrae, California, United States, 94904
- Withdrawn
- Marin Cancer Care Inc
-
Los Alamitos, California, United States, 90720
- Active, not recruiting
- Cancer Blood and Specialty Clinic
-
Los Angeles, California, United States, 90017-4803
- Active, not recruiting
- Los Angeles Cancer Network
-
Orange, California, United States, 92868
- Withdrawn
- University of California, Irvine Medical Center
-
Sacramento, California, United States, 95817
- Active, not recruiting
- UC Davis Comprehensive Cancer Center
-
-
Colorado
-
Denver, Colorado, United States, 80220
- Completed
- Rocky Mountain Cancer Centers
-
Greeley, Colorado, United States, 85234
- Withdrawn
- Banner MD Anderson Cancer Center
-
-
Connecticut
-
Norwich, Connecticut, United States, 06360-2740
- Withdrawn
- Eastern CT Hematology and Oncology Associates
-
-
Florida
-
Palm Bay, Florida, United States, 32901
- Withdrawn
- Cancer Care Centers of Brevard
-
Weston, Florida, United States, 33331
- Active, not recruiting
- Cleveland Clinic Florida
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University Hospital
-
Atlanta, Georgia, United States, 30303
- Active, not recruiting
- Grady Health System
-
Atlanta, Georgia, United States, 30318
- Active, not recruiting
- Midtown West Medical
-
Atlanta, Georgia, United States, 30342
- Active, not recruiting
- Winship Cancer Institute at Emory Saint Joseph's Hospital
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Withdrawn
- University of Louisville Hospital
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Withdrawn
- Karmanos Cancer Institute.
-
Grand Rapids, Michigan, United States, 49503
- Completed
- Cancer & Hematology Centers of Western Michigan
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55102
- Active, not recruiting
- Minnesota Oncology Hematology
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- Withdrawn
- MD Anderson Cancer Center At Cooper
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Withdrawn
- Novant Health Presbyterain Medical Center
-
Winston-Salem, North Carolina, United States, 27103
- Withdrawn
- Novant Health Forsyth Medical Center
-
-
Ohio
-
Canton, Ohio, United States, 44718
- Withdrawn
- Gabrail Cancer Center
-
-
Oregon
-
Medford, Oregon, United States, 97504-8332
- Completed
- Asante Rogue Regional Medical Center
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, United States, 19010-3121
- Withdrawn
- Bryn Mawr Hospital
-
Easton, Pennsylvania, United States, 18045
- Withdrawn
- St. Lukes Hospital and Health Network
-
Paoli, Pennsylvania, United States, 19301
- Withdrawn
- Paoli Memorial Hospital
-
West Chester, Pennsylvania, United States, 19380
- Withdrawn
- Abramson Cancer Center Chester County Hospital
-
Wynnewood, Pennsylvania, United States, 19096
- Withdrawn
- Lankenau Medical Center, Cancer Center
-
Wynnewood, Pennsylvania, United States, 19096
- Withdrawn
- Main Line Health System
-
York, Pennsylvania, United States, 17403
- Withdrawn
- WellSpan Oncology Research
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Withdrawn
- Texas Oncology West
-
Dallas, Texas, United States, 75231
- Active, not recruiting
- Texas Oncology - Dallas Presbyterian Hospital
-
El Paso, Texas, United States, 79905
- Withdrawn
- Texas Tech University Health Sciences Center
-
Flower Mound, Texas, United States, 75028
- Withdrawn
- Texas Oncology (Flower Mound) - USOR
-
Fort Worth, Texas, United States, 76104
- Withdrawn
- The Center for Cancer and Blood Disorders - Fort Worth
-
Kingwood, Texas, United States, 77339
- Withdrawn
- Lumi Research
-
McKinney, Texas, United States, 75071
- Withdrawn
- Texas Oncology McKinney
-
-
Washington
-
Kennewick, Washington, United States, 99336-7774
- Withdrawn
- Kadlec Clinic Hematology and Oncology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria for Main Study and Sub-study:
- If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1
- Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
- Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test
- Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy of > 6 months
- Adequate hematologic and organ function prior to initiation of study treatment
Exclusion Criteria for both Main Study and Sub-study:
- Metaplastic breast cancer
- Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway
- Participant who relapsed with documented evidence of progression > 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic disease
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Inability or unwillingness to swallow pills
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Any history of leptomeningeal disease or carcinomatous meningitis
- Known and untreated, or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases are eligible if they meet specific certain criteria
- Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
- Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- Requirement for daily supplemental oxygen
- Symptomatic active lung disease, including pneumonitis
- History of or active inflammatory bowel disease
- Any active bowel inflammation
- Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
- Participants with known human immunodeficiency virus infection that meet specific criteria
- History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence
- Chronic therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
- Active ongoing osteonecrosis of the jaw
Exclusion Criteria for Main Study Only:
- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment
- Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1
- Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer
- Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations
- History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms
Exclusion Criteria for Sub-study Only:
- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the substudy or within 2 weeks after the final dose of inavolisib and within 2 years after the final dose of fulvestrant, whichever is longer
- Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day -4 of Cycle 1
- Investigational drug(s) within 4 weeks prior to Day -4 or within 5 half-lives of the investigational drug(s), whichever is longer
- Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant formulations
- Treatment with mild, moderate, or strong inducers of CYP2B6, CYP3A4, and/or CYP2C19 (including St. John's Wort) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1
- Treatment with mild, moderate, or strong inhibitors of CYP2B6, CYP3A4, and/or CYP2C19 (including grapefruit juice or supplements) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inavolisib + Fulvestrant
Participants will be administered the treatments as outlined in the interventions section.
|
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 of main study and sub-study.
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 of main study and sub-study.
|
|
Active Comparator: Alpelisib + Fulvestrant
Participants will be administered the treatments as outlined in the interventions section.
|
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.
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 of main study and sub-study.
|
|
Experimental: Sub-study: Inavolisib + Fulvestrant + CYP substrates
Participants will be administered the treatments as outlined in the interventions section.
|
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 of main study and sub-study.
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 of main study and sub-study.
Participants will be administered bupropion PO on Day -3 and Day 12 of Cycle 1 of the sub-study.
Participants will be administered omerprazole PO on Day -4 and Day 11 of Cycle 1 of sub-study.
Participants will be administered midazolam PO on Day -4 and Day 11 of Cycle 1 of sub-study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
From randomization until disease progression or death due to any cause (up to approximately 64 months)
|
|
Sub-study: Maximum observed Drug Concentration (Cmax) for Midazolam
Time Frame: Day -4 and -3 of Cycle (C) 1, Day (D) 11 and C1D12. A cycle is 28 days.
|
Day -4 and -3 of Cycle (C) 1, Day (D) 11 and C1D12. A cycle is 28 days.
|
|
Sub-study: Cmax for Bupropion
Time Frame: Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.
|
Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.
|
|
Sub-study: Cmax for Omeprazole
Time Frame: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
|
Sub-study: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC [0-last]) for Midazolam
Time Frame: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
|
Sub-study: AUC (0-last) for Bupropion
Time Frame: Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.
|
Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.
|
|
Sub-study: AUC (0-last) for Omeprazole
Time Frame: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
|
Sub-study: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) for Midazolam
Time Frame: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
|
Sub-study: AUC (0-infinity) for Bupropion
Time Frame: Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.
|
Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.
|
|
Sub-study: AUC (0-infinity) for Omeprazole
Time Frame: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival (OS)
Time Frame: From randomization until death due to any cause (up to approximately 85 months)
|
From randomization until death due to any cause (up to approximately 85 months)
|
|
BICR-Assessed Overall Response Rate (ORR)
Time Frame: Up to approximately 64 months
|
Up to approximately 64 months
|
|
BICR-Assessed Best Overall Response (BOR)
Time Frame: Up to approximately 64 months
|
Up to approximately 64 months
|
|
BICR-Assessed Clinical Benefit Rate (CBR)
Time Frame: Up to approximately 64 months
|
Up to approximately 64 months
|
|
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)
|
From CR or PR until disease progression or death due to any cause (up to approximately 64 months)
|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
|
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)
|
Day 1 until 30 days after the final dose of study treatment (up to approximately 85 months)
|
|
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.
|
Day 1 and 15 of Cycle 1, and Day 1 of Cycles 2 and 3. Each cycle is 28 days.
|
|
Sub-study: Percentage of Participants with Adverse Events
Time Frame: Day -4 until 30 days after the final dose of study treatment (up to approximately 85 months)
|
Day -4 until 30 days after the final dose of study treatment (up to approximately 85 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2023
Primary Completion (Estimated)
November 13, 2026
Study Completion (Estimated)
March 30, 2029
Study Registration Dates
First Submitted
December 2, 2022
First Submitted That Met QC Criteria
December 2, 2022
First Posted (Actual)
December 12, 2022
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Breast Neoplasms
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Sulfoxides
- Sulfur Compounds
- Organic Chemicals
- Pyridines
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Benzimidazoles
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Polycyclic Compounds
- Steroids
- Fused-Ring Compounds
- Benzazepines
- Estradiol
- Estrenes
- Estranes
- Estradiol Congeners
- Gonadal Steroid Hormones
- Gonadal Hormones
- Benzodiazepines
- Ketones
- Propiophenones
- Fulvestrant
- Midazolam
- Omeprazole
- Bupropion
- inavolisib
- Alpelisib
Other Study ID Numbers
- WO43919
- 2022-502322-41-00 (Registry Identifier: EU Clinical Trials)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.