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ACTIVE NOT RECRUITING
NCT04191499
PHASE2/PHASE3

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

325

Start Date

2020-01-29

Completion Date

2027-11-15

Last Updated

2026-03-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Inavolisib

Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.

DRUG

Placebo

Participants will receive oral placebo on Days 1-28 of each 28-day cycle.

DRUG

Palbociclib

Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

DRUG

Fulvestrant

Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.

Locations (136)

Beverly Hills Cancer Center

Beverly Hills, California, United States

Massachusetts General Hospital.

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Sarah Cannon Research Institute / Tennessee Oncology

Chattanooga, Tennessee, United States

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology - Central South

Austin, Texas, United States

Texas Tech University Health Sciences Center

El Paso, Texas, United States

Texas Oncology - Northeast Texas

Tyler, Texas, United States

Northwest Medical Specialties

Tacoma, Washington, United States

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

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

Hosp Provincial D. Centenarios

Rosario, Argentina

Macquarie University Hospital

Macquarie Park, New South Wales, Australia

Southern Medical Day Care Centre

Wollongong, New South Wales, Australia

Mater Adult Hospital

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Western Health

Fitzroy, Victoria, Australia

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

UZ Leuven Gasthuisberg

Leuven, Belgium

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Arthur J.E. Child Comprehensive Cancer Center-Calgary

Calgary, Alberta, Canada

London Regional Cancer Program, London Health Sciences Centre, Baines Centre

London, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Hopital du Saint Sacrement

Québec, Quebec, Canada

Beijing Cancer Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China

Fujian Medical University Union Hospital

Fujian, China

Sun Yet-sen University Cancer Center

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Fudan University Shanghai Cancer Center

Shanghai, China

Hebei Medical University Fourth Hospital

Shijiazhuang, China

Tianjin Cancer Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, China

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

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

Vejle Sygehus

Vejle, Denmark

Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

Clermont-Ferrand, France

Centre Georges Francois Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Hopital Prive Jean Mermoz

Lyon, France

Institut régional du Cancer Montpellier

Montpellier, France

Institut Universitaire du Cancer de Toulouse-Oncopole

Toulouse, France

Israel-Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

Tbilisi Oncology Dispensary

Tbilisi, Georgia

Ambulantes Tumorzentrum Spandau

Berlin, Germany

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH

Essen, Germany

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

Klinikum Mutterhaus der Borromaeerinnen gGmbH

Trier, Germany

Universitätsfrauenklinik Ulm

Ulm, Germany

Anticancer Hospital Ag. Savas

Athens, Greece

Univ General Hosp Heraklion

Heraklion, Greece

Euromedical General Clinic of Thessaloniki

Thessaloniki, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Queen Mary Hospital

Hong Kong, Hong Kong

Orszagos Onkologiai Intezet

Budapest, Hungary

Uzsoki Utcai Korhaz

Budapest, Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, Hungary

A.O. Universitaria Di Parma

Parma, Emilia-Romagna, Italy

Az. Osp. Spedali Civili

Brescia, Lombardy, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Tuscany, Italy

IOV - Istituto Oncologico Veneto - IRCCS

Padova, Veneto, Italy

National Cancer Institute IKN

Putrajaya, Federal Territory of Putrajaya, Malaysia

Hospital Sultan Ismail

Johor Bahru, Johor, Malaysia

Sarawak General Hospital

Sarawak, Sarawak, Malaysia

Palmerston North Hospital

Palmerston North, New Zealand

Narodowy Instytut Onkologii Odzia? w Gliwicach

Gliwice, Poland

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, Poland

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad

Warsaw, Poland

Centro Clinico Champalimaud

Lisbon, Portugal

IPO do Porto

Porto, Portugal

Moscow Clinical Scientific Center

Moscow, Moscow Oblast, Russia

Blokhin Cancer Research Center

Moscow, Moscow Oblast, Russia

MEDSI Clinical Hospital on Pyatnitsky Highway

Moscow, Moscow Oblast, Russia

LLC Medscan

Moskva, Moscow Oblast, Russia

Clinical Hospital Lapino (LLC Haven)

Yudino, Moscow Oblast, Russia

Medical Clinic "AB Medical group"

Saint Petersburg, Sankt-Peterburg, Russia

Volgograd Regional Clinical Oncology Dispensary

Volgograd, Russia

Regional Clinical Oncology Hospital

Yaroslavl, Russia

National University Hospital

Singapore, Singapore

National Cancer Centre

Singapore, Singapore

Pusan National University Hospital

Busan, South Korea

Kyungpook National University Medical Center

Daegu, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital del Mar

Barcelona, Spain

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain

Insituto Catalán de Oncologia (ICO)

Barcelona, Spain

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

Jaén, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Clinica Universidad de Navarra-Madrid

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Instituto Valenciano Oncologia

Valencia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Kaohsiung Medical Uni Chung-Ho Hospital

Kaohsiung City, Taiwan

Veterans General Hospital

Taipei, Taiwan

National Taiwan Uni Hospital

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Tri-Service General Hospital, Division of General Surgery

Taipei, Taiwan

Ramathibodi Hospital

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Chulabhorn Hospital

Lak Si, Thailand

Songklanagarind Hospital

Songkhla, Thailand

Adana Baskent University Hospital

Adana, Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Ege University Medical Faculty

Bornova, ?zm?r, Turkey (Türkiye)

Istanbul University Cerrahpasa Faculty of Medicine

Istanbul, Turkey (Türkiye)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Turkey (Türkiye)

SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU

Kharkiv, Kharkiv Governorate, Ukraine

Municipal Institution SubCarpathian Clinical Oncological Centre

Ivano-Frankivsk, KIEV Governorate, Ukraine

Uzhhorod Central City Clinical Hospital

Uzhhorod, KIEV Governorate, Ukraine

City Clinical Hospital #4

Dnipropetrovsk, Ukraine

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council

Kryvyi Rih, Ukraine

Kyiv City Clinical Oncological Center

Kyiv, Ukraine

Royal Marsden Hospital - Fulham

London, United Kingdom

Mount Vernon Hospital

Northwood, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom