A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Start Date
9/8/2023
Completion Date
12/28/2032
Summary
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Inavolisib
Phesgo
Placebo
Taxane-based Chemotherapy
Optional Endocrine Therapy of Investigator's Choice
Conditions
Locations
Banner Health MD Anderson AZ
Gilbert, Arizona 85234
United States
Disney Family Cancer Center
Burbank, California 91505
United States
City of Hope
Corona, California 92882
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
City of Hope at Irvine Lennar
Irvine, California 92618
United States
Ellison Institute of Technology
Los Angeles, California 90064
United States
Georgetown Uni Hospital
Washington D.C., District of Columbia 20007
United States
Medstar Research Institute
Hyattsville, Maryland 20783
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Atrium Health
Charlotte, North Carolina 28209
United States
Hightower Clinical
Oklahoma City, Oklahoma 73102
United States
Renovatio Clinical - El Paso
El Paso, Texas 79915
United States
JPS Health Network
Fort Worth, Texas 76104
United States
Lumi Research
Kingwood, Texas 77339
United States
Renovatio Clinical
The Woodlands, Texas 77380
United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336-7774
United States
Swedish Medical Center
Seattle, Washington 98104-1360
United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Ciudad Autónoma de BuenosAires C1113AAE
Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE
Argentina
Hospital Provincial del Centenario
Rosario, S2002KDS
Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, J5400DIL
Argentina
Clínica Viedma
Viedma Rio Negro, R8500ACE
Argentina
Blacktown Hospital
Blacktown, New South Wales NSW 2148
Australia
Kinghorn Cancer Centre
Darlinghurst, New South Wales 2010
Australia
Gosford Hospital
Gosford, New South Wales 2250
Australia
University of the Sunshine Coast
Sippy Downs, Queensland 4556
Australia
Monash Health
Clayton, Victoria 3168
Australia
Sir Charles Gairdner Hospital
Perth, Western Australia 6009
Australia
Institut Jules Bordet
Anderlecht, 1070
Belgium
CHIREC
Auderghem, 1160
Belgium
CHU Brugmann (Victor Horta)
Brussels, 1020
Belgium
Cliniques Universitaires St-Luc
Brussels, 1200
Belgium
GHdC Site Les Viviers
Charleroi, 6000
Belgium
CHU HELORA - Hôpital de la Louvière - Site Jolimont
Haine-Saint-Paul, 7100
Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
Belgium
Clinique Ste-Elisabeth
Namur, 5000
Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará 60336-232
Brazil
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia 41253-190
Brazil
Hospital Araujo Jorge
Goiânia, Goiás 74605-070
Brazil
Hospital do Câncer de Londrina
Londrina, Paraná 86015-520
Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco 50040-000
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 Amor Amazônia
Porto Velho, Rondônia 76834-899
Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo 14784-400
Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo 01246-000
Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo 01317-001
Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta T2N 5G2
Canada
The Moncton Hospital
Moncton, New Brunswick E1C 6Z8
Canada
Eastern Health - General Hospital
St. John's, Newfoundland and Labrador A1B 3V6
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec H4J 1C5
Canada
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec PO 25223
Canada
Hopital du Saint Sacrement
Québec, Quebec G1S 4L8
Canada
Allan Blair Cancer Center
Regina, Saskatchewan S4T 7T1
Canada
Affiliated Hospital of Hebei University
Baoding, 071000
China
Beijing Cancer Hospital
Beijing, 100142
China
The First Hospital of Jilin University
Changchun, 130021
China
Sichuan Provincial Cancer Hospital
Chengdu, 610041
China
Sichuan Provincial People's Hospital
Chengdu, 610072
China
Fujian Cancer Hospital
Fuzhou, 350014
China
Zhejiang Cancer Hospital
Hangzhou, 310022
China
Harbin Medical University Tumor Hospital
Harbin, 150049
China
Shandong Cancer Hospital
Jinan, 250117
China
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang, 471003
China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021
China
Shantou Center Hospital
Shantou, 515031
China
Tianjin Cancer Hospital
Tianjin, 300000
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
China
Hubei Cancer Hospital
Wuhan, 430079
China
Clinica De La Costa
Barranquilla, 080020
Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., 110131
Colombia
Oncomedica S.A.
Montería, 230002
Colombia
Sociedad de Oncología y hematología del Cesar Ltda
Valledupar, 200001
Colombia
Tampere University Hospital
Tampere, 33520
Finland
Turku Uni Central Hospital
Turku, 20520
Finland
Institut Sainte Catherine
Avignon, 84082
France
Centre Hospitalier de La Cote Basque
Bayonne, 64109
France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
France
Centre Georges Francois Leclerc
Dijon, 21000
France
Centre Oscar Lambret
Lille, 59020
France
Klinikum St. Marien
Amberg, 92224
Germany
HELIOS Klinikum Berlin-Buch
Berlin, 13125
Germany
Marienhospital Bottrop gGmbH
Bottrop, 46236
Germany
Gynonco Düsseldorf, MVZ Medical Center GmbH
Düsseldorf, 40235
Germany
Frauenarztpraxis Dr. Apel, Dr. Kolpin
Erfurt, 99084
Germany
Universitätsklinikum Erlangen
Erlangen, 91054
Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110
Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, 80336
Germany
St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren
Münster, 48145
Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, 66113
Germany
Gynäkologie Kompetenzzentrum
Stralsund, 18439
Germany
Universitätsfrauenklinik Ulm
Ulm, 89075
Germany
Queen Mary Hospital
Hong Kong,
Hong Kong
Tuen Mun Hospital
Hong Kong,
Hong Kong
Gujarat Cancer & Research Inst.
Ahmedabad, Gujarat 380016
India
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
Surat, Gujarat 395007
India
Artemis Hospital
Gurugram, Haryana 122001
India
Sir H. N. Reliance Foundation Hospital and Research Centre
Mumbai, Maharashtra 400004
India
National Cancer Institute
Nagpur, Maharashtra 441108
India
Max Super Speciality Hospital
NEW Delhi Delhi, National Capital Territory of Delhi 110092
India
Tata Medical Center
Kolkata, West Bengal 700160
India
I.R.S.T Srl IRCCS
Meldola, Emilia-Romagna 47014
Italy
Ospedale San Giovanni Addolorata
Rome, Lazio 00185
Italy
Ospedale San Raffaele
Milan, Lombardy 20132
Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy 20133
Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy 20141
Italy
Ospedale San Gerardo
Monza, Lombardy 20900
Italy
A.O.U. Maggiore della Carità
Novara, Piedmont 28100
Italy
Casa di Cura La Maddalena
Palermo, Sicily 90146
Italy
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Tuscany 50012
Italy
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
Verona, Veneto 37124
Italy
Nagoya City University Hospital
Aichi, 467-8602
Japan
Chiba Cancer Center
Chiba, 260-8717
Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
Japan
Sagara Hospital
Kagoshima, 892-0833
Japan
Tokai University Hospital
Kanagawa, 259-1193
Japan
Kyoto University Hospital
Kyoto, 606-8507
Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280
Japan
Saitama Medical University International Medical Center
Saitama, 350-1298
Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Japan
King Hussein Cancer Center
Amman, 11941
Jordan
University of Nairobi - Institute of Tropical and Infectious Diseases
Nairobi,
Kenya
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco 44280
Mexico
OncoMed
Mexico City, Mexico CITY (federal District) 03100
Mexico
Centro Oncológico Hematológico Roma
Mexico City, Mexico CITY (federal District) 06700
Mexico
Hospital Universitario
Monterrey, Nuevo León 64460
Mexico
CENEIT Oncologicos
Mexico City, 03100
Mexico
Sultan Qaboos Comprehensive Cancer Care & Research Center
Muscat,
Oman
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, 85-796
Poland
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
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
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Późna, 61-866
Poland
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
Warsaw, 02-781
Poland
National University Hospital
Singapore, 119228
Singapore
National Cancer Centre
Singapore, 169610
Singapore
Icon Cancer Centre Farrer Park
Singapore, 217562
Singapore
Tan Tock Seng Hospital
Singapore, 308433
Singapore
Hopelands Cancer Centre
Hilton, 3245
South Africa
Charlotte Maxeke Academic Hospital
Johannesburg, 2193
South Africa
Medical Oncology Centre of Rosebank
Johannesburg, 2196
South Africa
Limpopo Cancer Research Institute
Polokwane, 0700
South Africa
Steve Biko Academic Hospital
Pretoria, 0002
South Africa
Chris Hani Baragwanath Clinical Trial Site
Soweto, 2013
South Africa
National Cancer Center
Goyang-si, 10408
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
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna 15006
Spain
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, 08028
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
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 Clinico Universitario Virgen de la Victoria
Málaga, 29010
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
National Taiwan Uni Hospital
Taipei, 100
Taiwan
Tri-Service General Hospital
Taipei,
Taiwan
Chang Gung Memorial Hospital-Linkou
Taoyuan County, 333
Taiwan
Abderrahmen Mami Hospital
Aryanah, 2080
Tunisia
Taher Maamouri Hospital
Nabeul, 8000
Tunisia
Habib Bourguiba Hospital
Sfax, 3029
Tunisia
Farhat Hached Hospital
Sousse, 4031
Tunisia
Institut Salah Azeiz
Tunis, 1006
Tunisia
Sakarya Training and Research Hospital
Adapazarı, 54290
Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 06010
Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500
Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147
Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, 21280
Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, 34214
Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, 35360
Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, 01140
Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, 06230
Turkey (Türkiye)
Uganda Cancer Institute
Kampala, 00256
Uganda
Belfast City Hospital
Belfast, BT9 7AB
United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR
United Kingdom
Colchester General Hospital
Colchester, Essex, CO4 5JL
United Kingdom
Mount Vernon Hospital
Northwood, HA6 2RN
United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB
United Kingdom
Churchill Hospital
Oxford, OX3 7LJ
United Kingdom