AzTrials
AzTrials

Breast CancerPhase 3INAVO121NCT05646862

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

A Phase 3 study testing Inavolisib, Fulvestrant and Alpelisib in people with Breast Cancer, run by Hoffmann-La Roche at 210 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Inavolisib, Fulvestrant and Alpelisib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
210 sitesin 20 countries
Study dates
7 Jun 2023to 30 Mar 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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
  • 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
  • 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

Trial locations and contacts

210 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: WO43919 https://forpatients.roche.com/ No attachments to email below contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

210 sites in 20 countries

United States39 sites, 2 recruiting

  • Texas Oncology West

    Amarillo, Texas, 79106

    Withdrawn

  • Grady Health System

    Atlanta, Georgia, 30303

    Active, not recruiting

  • Midtown West Medical

    Atlanta, Georgia, 30318

    Active, not recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Recruiting

  • Winship Cancer Institute at Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Active, not recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010-3121

    Withdrawn

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

    Withdrawn

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Withdrawn

  • Novant Health Presbyterain Medical Center

    Charlotte, North Carolina, 28204

    Withdrawn

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

    Active, not recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

    Completed

  • Karmanos Cancer Institute.

    Detroit, Michigan, 48201

    Withdrawn

  • St. Lukes Hospital and Health Network

    Easton, Pennsylvania, 18045

    Withdrawn

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

    Withdrawn

  • Texas Oncology (Flower Mound) - USOR

    Flower Mound, Texas, 75028

    Withdrawn

  • The Center for Cancer and Blood Disorders - Fort Worth

    Fort Worth, Texas, 76104

    Withdrawn

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

    Completed

  • Banner MD Anderson Cancer Center

    Greeley, Colorado, 85234

    Withdrawn

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

    Withdrawn

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336-7774

    Withdrawn

  • Lumi Research

    Kingwood, Texas, 77339

    Withdrawn

  • Cancer Blood and Specialty Clinic

    Los Alamitos, California, 90720

    Active, not recruiting

  • Los Angeles Cancer Network

    Los Angeles, California, 90017-4803

    Active, not recruiting

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

    Withdrawn

  • Texas Oncology McKinney

    McKinney, Texas, 75071

    Withdrawn

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504-8332

    Completed

  • Eastern CT Hematology and Oncology Associates

    Norwich, Connecticut, 06360-2740

    Withdrawn

  • University of California, Irvine Medical Center

    Orange, California, 92868

    Withdrawn

  • Cancer Care Centers of Brevard

    Palm Bay, Florida, 32901

    Withdrawn

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

    Withdrawn

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Active, not recruiting

  • Minnesota Oncology Hematology

    Saint Paul, Minnesota, 55102

    Active, not recruiting

  • Abramson Cancer Center Chester County Hospital

    West Chester, Pennsylvania, 19380

    Withdrawn

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Active, not recruiting

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

    Withdrawn

  • Lankenau Medical Center, Cancer Center

    Wynnewood, Pennsylvania, 19096

    Withdrawn

  • Main Line Health System

    Wynnewood, Pennsylvania, 19096

    Withdrawn

  • WellSpan Oncology Research

    York, Pennsylvania, 17403

    Withdrawn

Other trials in United States

China16 sites

  • The First Hospital of Jilin University

    Changchun, 130021

    Completed

  • Sichuan Provincial Cancer Hospital

    Chengdu, 610041

    Completed

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016

    Withdrawn

  • Sun yat-sen University Cancer Center

    Guangzhou, 510060

    Completed

  • Guangdong Provincial People's Hospital

    Guangzhou, 510180

    Active, not recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009

    Completed

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016

    Completed

  • Harbin Medical University Tumor Hospital

    Harbin, 150049

    Completed

  • Shandong Cancer Hospital

    Jinan, 250117

    Withdrawn

  • The Second Affiliated Hospital to Nanchang University

    Nanchang, 330006

    Completed

  • Jiangsu Cancer Hospital

    Nanjing, 211100

    Active, not recruiting

  • Tianjin Cancer Hospital

    Tianjin, 300000

    Active, not recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430023

    Completed

  • Hubei Cancer Hospital

    Wuhan, 430079

    Active, not recruiting

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

    Active, not recruiting

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

    Active, not recruiting

Other trials in China

Germany13 sites

  • Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin

    Aachen, 52074

    Completed

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604

    Withdrawn

  • Universitätsklinikum Essen

    Essen, 45122

    Active, not recruiting

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

    Active, not recruiting

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

    Georgsmarienhütte, 49124

    Withdrawn

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen, 37075

    Completed

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg, 20357

    Active, not recruiting

  • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

    Hanover, 30625

    Active, not recruiting

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120

    Completed

  • Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

    Mönchengladbach, 41061

    Active, not recruiting

  • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

    München, 80336

    Withdrawn

  • St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise

    Paderborn, 33098

    Active, not recruiting

  • MVZ für Hämatologie und Onkologie Ravensburg GmBH

    Ravensburg, 88212

    Withdrawn

Other trials in Germany

Brazil12 sites, 2 recruiting

  • NUPEC

    Belo Horizonte, Minas Gerais, 30210-090

    Completed

  • Instituto D?Or de Pesquisa e Ensino ? Hospital DF STAR

    Brasília, Federal District, 70390-140

    Withdrawn

  • Hospital Santa Cruz / Centro de Oncologia D'Or

    Curitiba, Paraná, 80420-090

    Recruiting

  • Liga Norte Riograndense Contra O Câncer

    Natal, Rio Grande do Norte, 59040150

    Completed

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

    Active, not recruiting

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

    Withdrawn

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000

    Completed

  • Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife

    Recife, Pernambuco

    Active, not recruiting

  • Hospital da Bahia

    Salvador, Estado de Bahia, 41810-011

    Withdrawn

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

    Recruiting

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

    Active, not recruiting

  • Vencer Oncoclínica - Centro de Pesquisa do Piauí

    Teresina, Piauí, 64049-200

    Withdrawn

Other trials in Brazil

South Korea12 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Completed

  • National Cancer Center

    Goyang-si, 10408

    Active, not recruiting

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

    Withdrawn

  • Catholic Univ. of Incheon St.Mary's Hospital

    Incheon, 21431

    Withdrawn

  • Inha University Hospital

    Incheon, 22332

    Withdrawn

  • Korea University Anam Hospital

    Seoul, 02841

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Active, not recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Active, not recruiting

  • Asan Medical Center

    Seoul, 05505

    Active, not recruiting

  • Gangnam Severance Hospital

    Seoul, 06273

    Active, not recruiting

  • Samsung Medical Center

    Seoul, 06351

    Active, not recruiting

  • Seoul St Mary's Hospital

    Seoul, 06591

    Active, not recruiting

Other trials in South Korea

United Kingdom12 sites

  • Basingstoke and North Hampshire Hospital

    Basingstoke, RG24 9NA

    Withdrawn

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

    Active, not recruiting

  • Dumfries and Galloway Royal Infirmary

    Dumfries, DG1 4AP

    Withdrawn

  • Western General Hospital

    Edinburgh, EH4 2XU

    Active, not recruiting

  • Princess Alexandra Hospital

    Harlow, CM20 1QX

    Active, not recruiting

  • St John's Hospital

    Livingston, EH54 6PP

    Withdrawn

  • St Bartholomew's Hospital

    London, EC1M 6BQ

    Completed

  • Maidstone & Tonbridge Wells Hospital

    Maidstone, ME16 9QQ

    Completed

  • Mount Vernon & Watford Hospital Trust

    Northwood, HA6 2RN

    Active, not recruiting

  • Churchill Hospital

    Oxford, OX3 7LE

    Active, not recruiting

  • Royal Preston Hosptial

    Preston, PR2 9HT

    Withdrawn

  • Royal Hampshire County Hospital

    Winchester, SO22 5DG

    Withdrawn

Other trials in United Kingdom

Italy11 sites

  • ASL AL - Azienda Sanitaria Locale AL

    Alessandria, Piedmont, 15121

    Withdrawn

  • Irccs Centro Di Riferimento Oncologico (CRO)

    Aviano, Friuli Venezia Giulia, 33081

    Withdrawn

  • A.O. S. Anna e San Sebastiano

    Caserta, Campania, 81100

    Active, not recruiting

  • Ospedale S. Giuseppe

    Empoli (FI), Tuscany, 50053

    Withdrawn

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014

    Active, not recruiting

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

    Active, not recruiting

  • Humanitas Centro Catanese Di Oncologia

    Misterbianco (CT), Sicily, 95045

    Withdrawn

  • Ospedale Di Macerata

    Province of Macerata, The Marches, 62100

    Withdrawn

  • AUSL della Romagna

    Ravenna, Emilia-Romagna, 48121

    Withdrawn

  • Ospedale Santa Chiara

    Trento, Trentino-Alto Adige, 38100

    Completed

  • AOU Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

    Withdrawn

Other trials in Italy

Spain11 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Withdrawn

  • Hospital San Pedro De Alcantara

    Cáceres, 10003

    Completed

  • ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

    Active, not recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Active, not recruiting

  • Hospital Ramon y Cajal

    Madrid, 28034

    Active, not recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Active, not recruiting

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29011

    Completed

  • Hospital Universitario Virgen de Arrixaca

    Murcia, 30120

    Withdrawn

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

    Active, not recruiting

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna, 15706

    Withdrawn

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Active, not recruiting

Other trials in Spain

Turkey (Türkiye)11 sites

  • Gulhane Training and Applicaton Hospital

    Ankara, 06010

    Completed

  • Memorial Ankara Hastanesi

    Ankara, 06520

    Completed

  • Dicle University Faculty of Medicine

    Diyarbakır, 21280

    Completed

  • Trakya University Medical Faculty

    Edirne, 22030

    Completed

  • Medipol Mega Üniversite Hastanesi Göztepe

    Istanbul, 34214

    Completed

  • Marmara Uni Faculty of Medicine

    Istanbul, 34890

    Completed

  • Ege Uni Medical Faculty Hospital

    Izmir, 35100

    Active, not recruiting

  • Izmir Ataturk Training and Research Hospital

    Izmir, 35360

    Active, not recruiting

  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital

    Kadiköy, 34722

    Completed

  • Medical Park Seyhan Hospital

    Seyhan, 01140

    Withdrawn

  • Hacettepe Uni Medical Faculty Hospital

    Sihhiye/Ankara, 06230

    Active, not recruiting

Other trials in Turkey (Türkiye)

Canada10 sites

  • Arthur J.E. Child Comprehensive Cancer Center-Calgary

    Calgary, Alberta, T2N 5G2

    Active, not recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Active, not recruiting

  • Juravinski Hospital

    Hamilton, Ontario, L8V 5C2

    Completed

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

    Active, not recruiting

  • CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

    Completed

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0C2

    Completed

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Completed

  • Hôpital du Sacré-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

    Completed

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1Y 4E9

    Active, not recruiting

  • BC Cancer ? Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Completed

Other trials in Canada

Australia9 sites

  • Icon Cancer Care Wesley

    Auchenflower, Queensland, 4066

    Completed

  • Bendigo Cancer Centre

    Bendigo, Victoria, 3550

    Active, not recruiting

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

    Withdrawn

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450

    Active, not recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

    Completed

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010

    Active, not recruiting

  • Gosford Hospital

    Gosford, New South Wales, 2250

    Completed

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

    Active, not recruiting

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556

    Withdrawn

Other trials in Australia

Mexico9 sites

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080

    Completed

  • Panamerican Clinical Research S.A de C.V.

    Guadalajara, Jalisco, 44670

    Active, not recruiting

  • RENATI INNOVATION S.A.P.I. de C.V

    Guadalajara, Jalisco, 44680

    Completed

  • COI Centro Oncologico Internacional Santa Fe

    Mexico City, Mexico CITY (federal District), 01330

    Completed

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

    Completed

  • OncoMed

    Mexico City, Mexico CITY (federal District), 03100

    Active, not recruiting

  • ARKE Estudios Clínicos S.A. de C.V.

    Mexico City, Mexico CITY (federal District), 06700

    Active, not recruiting

  • CENEIT Oncologicos

    Mexico City, 03100

    Completed

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Morelia, 58260

    Active, not recruiting

Other trials in Mexico

Argentina8 sites

  • Centro de Investigaciones Médicas y Desarrollo LC S.R.L

    Buenos Aires, C1113AAE

    Completed

  • Centro Oncologico Korben

    Ciudad Autonoma Buenos Aires, C1426AGE

    Active, not recruiting

  • Fundacion CORI para la Investigacion y Prevencion del Cancer

    La Rioja, F5300COE

    Completed

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

    Active, not recruiting

  • Sanatorio Parque S.A.

    Rosario, S2000QGB

    Withdrawn

  • Hosp Provincial D. Centenarios

    Rosario, S2002KDS

    Active, not recruiting

  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

    San Juan, J5400DIL

    Completed

  • Clinica Viedma S.A.

    Viedma, R8500ACE

    Completed

Other trials in Argentina

Poland8 sites

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796

    Completed

  • Szpital Morski im.PCK

    Gdynia, 81-519

    Withdrawn

  • Narodowy Instytut Onkologii Odzia? w Gliwicach

    Gliwice, 44-102

    Active, not recruiting

  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Konin, 62-500

    Completed

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581

    Active, not recruiting

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

    Active, not recruiting

  • MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

    Rzeszów, 35-021

    Active, not recruiting

  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

    Warsaw, 02-781

    Active, not recruiting

Other trials in Poland

France7 sites

  • Institut Sainte Catherine

    Avignon, 84082

    Withdrawn

  • Centre Hospitalier de La Cote Basque

    Bayonne, 64109

    Active, not recruiting

  • Polyclinique Bordeaux Nord

    Bordeaux, 33300

    Withdrawn

  • Centre Leon Berard

    Lyon, 69008

    Active, not recruiting

  • ICM

    Montpellier, 34298

    Active, not recruiting

  • Centre Eugene Marquis

    Rennes, 35042

    Active, not recruiting

  • IUCT Oncopole

    Toulouse, 31100

    Active, not recruiting

Other trials in France

Belgium6 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

    Active, not recruiting

  • GHdC Site Les Viviers

    Charleroi, 6000

    Completed

  • UZ Antwerpen

    Edegem, 2650

    Completed

  • UZ Gent

    Ghent, 9000

    Active, not recruiting

  • UZ Leuven Gasthuisberg

    Leuven, 3000

    Active, not recruiting

  • Clinique Ste-Elisabeth

    Namur, 5000

    Active, not recruiting

Other trials in Belgium

Taiwan6 sites

  • China Medical University Hospital

    Taichung, 404

    Active, not recruiting

  • National Cheng Kung University Hospital

    Tainan, 70457

    Active, not recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Completed

  • Chang Gung Memorial Hosipital at Linkou

    Taoyuan City, 333

    Completed

  • Veterans General Hospital - Taichung

    Xitun Dist., 40705

    Active, not recruiting

  • National Taiwan University Hospital

    Zhongzheng Dist., 10048

    Active, not recruiting

Other trials in Taiwan

South Africa5 sites

  • Dr. W.M. Szpak Incorporated trading as Rainbow Oncology

    Durban, 4126

    Withdrawn

  • Hopelands Cancer Centre

    Hilton, 3245

    Withdrawn

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196

    Completed

  • Richards Bay Oncology Centre

    KwaZulu Natal, 3900

    Completed

  • Mountain View Oncology

    Paarl, 7646

    Withdrawn

Other trials in South Africa

Thailand4 sites

  • Chulalongkorn Hospital

    Bangkok, 10330

    Withdrawn

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

    Withdrawn

  • Chulabhorn Hospital

    Lak Si, 10210

    Withdrawn

  • Songklanagarind Hospital

    Songkhla, 90110

    Withdrawn

Other trials in Thailand

New Zealand1 site, 1 recruiting

  • New Zealand Clinical Research - Auckland

    Auckland, 1010

    Recruiting

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

    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.

  • FulvestrantDrug

    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.

  • AlpelisibDrug

    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.

  • BupropionDrug

    Participants will be administered bupropion PO on Day -3 and Day 12 of Cycle 1 of the sub-study.

  • OmeprazoleDrug

    Participants will be administered omerprazole PO on Day -4 and Day 11 of Cycle 1 of sub-study.

  • MidazolamDrug

    Participants will be administered midazolam PO on Day -4 and Day 11 of Cycle 1 of sub-study.

Study groups in NCT05646862
Study groupRoleWhat they receive
Inavolisib + FulvestrantExperimentalParticipants will be administered the treatments as outlined in the interventions section.
Receives: Drug: Inavolisib; Drug: Fulvestrant
Alpelisib + FulvestrantActive comparatorParticipants will be administered the treatments as outlined in the interventions section.
Receives: Drug: Fulvestrant; Drug: Alpelisib
Sub-study: Inavolisib + Fulvestrant + CYP substratesExperimentalParticipants will be administered the treatments as outlined in the interventions section.
Receives: Drug: Inavolisib; Drug: Fulvestrant; Drug: Bupropion; Drug: Omeprazole; Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)

    Measured: From randomization until disease progression or death due to any cause (up to approximately 64 months)

  2. Sub-study: Maximum observed Drug Concentration (Cmax) for Midazolam

    Measured: Day -4 and -3 of Cycle (C) 1, Day (D) 11 and C1D12. A cycle is 28 days.

  3. Sub-study: Cmax for Bupropion

    Measured: Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.

  4. Sub-study: Cmax for Omeprazole

    Measured: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.

  5. Sub-study: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC [0-last]) for Midazolam

    Measured: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.

  6. Sub-study: AUC (0-last) for Bupropion

    Measured: Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.

  7. Sub-study: AUC (0-last) for Omeprazole

    Measured: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.

  8. Sub-study: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) for Midazolam

    Measured: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.

  9. Sub-study: AUC (0-infinity) for Bupropion

    Measured: Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.

  10. Sub-study: AUC (0-infinity) for Omeprazole

    Measured: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.

Secondary outcomes (12)

  1. Overall survival (OS)

    Measured: From randomization until death due to any cause (up to approximately 85 months)

  2. BICR-Assessed Overall Response Rate (ORR)

    Measured: Up to approximately 64 months

  3. BICR-Assessed Best Overall Response (BOR)

    Measured: Up to approximately 64 months

  4. BICR-Assessed Clinical Benefit Rate (CBR)

    Measured: Up to approximately 64 months

  5. BICR-Assessed Duration of Response (DOR)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: Day 1 and 15 of Cycle 1, and Day 1 of Cycles 2 and 3. Each cycle is 28 days.

  12. Sub-study: Percentage of Participants with Adverse Events

    Measured: Day -4 until 30 days after the final dose of study treatment (up to approximately 85 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2022
  2. Study start7 Jun 2023
  3. Primary completion13 Nov 2026 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05646862
Sponsor's protocol ID
WO43919
Other IDs
2022-502322-41-00
Acronym
INAVO121
Status last verified
Oct 2026
First submitted
2 Dec 2022
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inavolisib, Fulvestrant and Alpelisib in people with Breast Cancer, run by Hoffmann-La Roche at 210 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, China, Germany, Brazil, South Korea and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: WO43919 https://forpatients.roche.com/ No attachments to email below (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05646862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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