A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants... | NCT05894239 | Trialant

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants... | NCT05894239 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection

Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity

Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status

Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months

LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)

Adequate hematologic and organ function prior to initiation of study treatment

Exclusion Criteria:

Prior treatment in the 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

Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy

History or active inflammatory bowel disease

Disease progression within 6 months of receiving any HER2-targeted therapy

Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

Participants with active HBV infection

Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis

Symptomatic active lung disease, including pneumonitis or interstitial lung disease

Any history of leptomeningeal disease or carcinomatous meningitis

Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1

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

Banner Health MD Anderson AZRecruiting

Gilbert, Arizona 85234, United States

Disney Family Cancer CenterRecruiting

Burbank, California 91505, United States

City of HopeRecruiting

Corona, California 92882, United States

City of Hope Comprehensive Cancer CenterRecruiting

Duarte, California 91010, United States

City of Hope at Irvine LennarRecruiting

Irvine, California 92618, United States

Ellison Medical InstituteRecruiting

Los Angeles, California 90064, United States

Georgetown Uni HospitalRecruiting

Washington D.C., District of Columbia 20007, United States

Medstar Research InstituteRecruiting

Hyattsville, Maryland 20783, United States

Dana Farber Cancer InstituteRecruiting

Boston, Massachusetts 02215, United States

Henry Ford HospitalRecruiting

Detroit, Michigan 48202, United States

Renown Regional Medical CenterWithdrawn

Reno, Nevada 89502, United States

Hackensack University Medical CenterWithdrawn

Hackensack, New Jersey 07601, United States

Atrium HealthRecruiting

Charlotte, North Carolina 28209, United States

Hightower ClinicalWithdrawn

Oklahoma City, Oklahoma 73102, United States

Renovatio Clinical - El PasoRecruiting

El Paso, Texas 79915, United States

JPS Health NetworkRecruiting

Fort Worth, Texas 76104, United States

Lumi ResearchWithdrawn

Kingwood, Texas 77339, United States

Renovatio ClinicalRecruiting

The Woodlands, Texas 77380, United States

Kadlec Clinic Hematology and OncologyRecruiting

Kennewick, Washington 99336-7774, United States

Swedish Medical CenterRecruiting

Seattle, Washington 98104-1360, United States

Centro de Investigaciones Médicas y Desarrollo LC S.R.LActive, not recruiting

Buenos Aires, Ciudad Autónoma de BuenosAires C1113AAE, Argentina

Centro Oncologico KorbenActive, not recruiting

Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

Instituto de Oncología de RosarioActive, not recruiting

Rosario, S2000KZE, Argentina

Hospital Provincial del CentenarioActive, not recruiting

Rosario, S2002KDS, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion ClinicaActive, not recruiting

San Juan, J5400DIL, Argentina

Clínica ViedmaWithdrawn

Viedma Rio Negro, R8500ACE, Argentina

Blacktown HospitalWithdrawn

Blacktown, New South Wales NSW 2148, Australia

Kinghorn Cancer CentreWithdrawn

Darlinghurst, New South Wales 2010, Australia

Gosford HospitalWithdrawn

Gosford, New South Wales 2250, Australia

University of the Sunshine CoastWithdrawn

Sippy Downs, Queensland 4556, Australia

Monash HealthCompleted

Clayton, Victoria 3168, Australia

Sir Charles Gairdner HospitalCompleted

Perth, Western Australia 6009, Australia

Institut Jules BordetWithdrawn

Anderlecht, 1070, Belgium

CHIRECWithdrawn

Auderghem, 1160, Belgium

CHU Brugmann (Victor Horta)Withdrawn

Brussels, 1020, Belgium

Cliniques Universitaires St-LucWithdrawn

Brussels, 1200, Belgium

GHdC Site Les ViviersWithdrawn

Charleroi, 6000, Belgium

CHU HELORA - Hôpital de la Louvière - Site JolimontActive, not recruiting

Haine-Saint-Paul, 7100, Belgium

Jessa Zkh (Campus Virga Jesse)Withdrawn

Hasselt, 3500, Belgium

Clinique Ste-ElisabethWithdrawn

Namur, 5000, Belgium

Crio - Centro Regional Integrado de OncologiaRecruiting

Fortaleza, Ceará 60336-232, Brazil

Hospital Sao Rafael - HSRRecruiting

Salvador, Estado de Bahia 41253-190, Brazil

Hospital Araujo JorgeRecruiting

Goiânia, Goiás 74605-070, Brazil

Hospital do Câncer de LondrinaRecruiting

Londrina, Paraná 86015-520, Brazil

Hospital do Cancer de Pernambuco - HCPRecruiting

Recife, Pernambuco 50040-000, Brazil

Santa Casa de Misericordia de Porto AlegreActive, not recruiting

Porto Alegre, Rio Grande do Sul 90050-170, Brazil

Hospital Sao Lucas - PUCRSRecruiting

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Hospital de Amor AmazôniaRecruiting

Porto Velho, Rondônia 76834-899, Brazil

Hospital de Cancer de BarretosRecruiting

Barretos, São Paulo 14784-400, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting

São Paulo, São Paulo 01246-000, Brazil

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria LtdaRecruiting

São Paulo, São Paulo 01317-001, Brazil

Arthur J.E. Child Comprehensive Cancer Center-CalgaryRecruiting

Calgary, Alberta T2N 5G2, Canada

The Moncton HospitalRecruiting

Moncton, New Brunswick E1C 6Z8, Canada

Eastern Health - General HospitalWithdrawn

St. John's, Newfoundland and Labrador A1B 3V6, Canada

Sunnybrook Health Sciences CentreRecruiting

Toronto, Ontario M4N 3M5, Canada

Jewish General HospitalRecruiting

Montreal, Quebec H3T 1E2, Canada

Hôpital du Sacré-Coeur de MontrealRecruiting

Montreal, Quebec H4J 1C5, Canada

Centre Hospitalier de l?Université de Montréal (CHUM)Recruiting

Montreal, Quebec PO 25223, Canada

Hopital du Saint SacrementRecruiting

Québec, Quebec G1S 4L8, Canada

Allan Blair Cancer CenterWithdrawn

Regina, Saskatchewan S4T 7T1, Canada

Affiliated Hospital of Hebei UniversityRecruiting

Baoding, 071000, China

Beijing Cancer HospitalRecruiting

Beijing, 100142, China

The First Hospital of Jilin UniversityRecruiting

Changchun, 130021, China

Sichuan Provincial Cancer HospitalCompleted

Chengdu, 610041, China

Sichuan Provincial People's HospitalActive, not recruiting

Chengdu, 610072, China

Fujian Cancer HospitalRecruiting

Fuzhou, 350014, China

Zhejiang Cancer HospitalActive, not recruiting

Hangzhou, 310022, China

Harbin Medical University Tumor HospitalActive, not recruiting

Harbin, 150049, China

Shandong Cancer HospitalRecruiting

Jinan, 250117, China

The First Affiliated Hospital to Henan University of Science and TechnologyRecruiting

Luoyang, 471003, China

The Second Affiliated Hospital to Nanchang UniversityActive, not recruiting

Nanchang, 330006, China

Guangxi Cancer Hospital of Guangxi Medical UniversityActive, not recruiting

Nanning, 530021, China

Shantou Center HospitalWithdrawn

Shantou, 515031, China

Tianjin Cancer HospitalRecruiting

Tianjin, 300000, China

Union Hospital Tongji Medical College Huazhong University of Science and TechnologyActive, not recruiting

Wuhan, 430022, China

Hubei Cancer HospitalActive, not recruiting

Wuhan, 430079, China

Clinica De La CostaWithdrawn

Barranquilla, 080020, Colombia

Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento AnguloRecruiting

Bogota, D.C., 110131, Colombia

Oncomedica S.A.Recruiting

Montería, 230002, Colombia

Sociedad de Oncología y hematología del Cesar LtdaRecruiting

Valledupar, 200001, Colombia

Tampere University HospitalWithdrawn

Tampere, 33520, Finland

Turku Uni Central HospitalWithdrawn

Turku, 20520, Finland

Institut Sainte CatherineRecruiting

Avignon, 84082, France

Centre Hospitalier de La Cote BasqueRecruiting

Bayonne, 64109, France

Polyclinique Bordeaux Nord AquitaineRecruiting

Bordeaux, 33300, France

Centre Georges Francois LeclercRecruiting

Dijon, 21000, France

Centre Oscar LambretRecruiting

Lille, 59020, France

Klinikum St. MarienRecruiting

Amberg, 92224, Germany

HELIOS Klinikum Berlin-BuchRecruiting

Berlin, 13125, Germany

Marienhospital Bottrop gGmbHRecruiting

Bottrop, 46236, Germany

Gynonco Düsseldorf, MVZ Medical Center GmbHWithdrawn

Düsseldorf, 40235, Germany

Frauenarztpraxis Dr. Apel, Dr. KolpinRecruiting

Erfurt, 99084, Germany

Universitätsklinikum ErlangenRecruiting

Erlangen, 91054, Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbRRecruiting

Freiburg im Breisgau, 79110, Germany

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus InnenstadtRecruiting

München, 80336, Germany

St. Franziskus Hospital Münster;Studiensekretariat der onkologischen ZentrenRecruiting

Münster, 48145, Germany

Caritas Klinik St. Theresia -Frauenklinik BrustzentrumRecruiting

Saarbrücken, 66113, Germany

Gynäkologie KompetenzzentrumWithdrawn

Stralsund, 18439, Germany

Universitätsfrauenklinik UlmRecruiting

Ulm, 89075, Germany

Queen Mary HospitalRecruiting

Hong Kong, Hong Kong

Tuen Mun HospitalRecruiting

Hong Kong, Hong Kong

Gujarat Cancer & Research Inst.Recruiting

Ahmedabad, Gujarat 380016, India

Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)Recruiting

Surat, Gujarat 395007, India

Artemis HospitalRecruiting

Gurugram, Haryana 122001, India

Sir H. N. Reliance Foundation Hospital and Research CentreWithdrawn

Mumbai, Maharashtra 400004, India

National Cancer InstituteRecruiting

Nagpur, Maharashtra 441108, India

Max Super Speciality HospitalWithdrawn

NEW Delhi Delhi, National Capital Territory of Delhi 110092, India

Tata Medical CenterWithdrawn

Kolkata, West Bengal 700160, India

I.R.S.T Srl IRCCSActive, not recruiting

Meldola, Emilia-Romagna 47014, Italy

Ospedale San Giovanni AddolorataActive, not recruiting

Rome, Lazio 00185, Italy

Ospedale San RaffaeleActive, not recruiting

Milan, Lombardy 20132, Italy

Irccs Istituto Nazionale Dei Tumori (Int)Active, not recruiting

Milan, Lombardy 20133, Italy

Irccs Istituto Europeo Di Oncologia (IEO)Active, not recruiting

Milan, Lombardy 20141, Italy

Ospedale San GerardoWithdrawn

Monza, Lombardy 20900, Italy

A.O.U. Maggiore della CaritàActive, not recruiting

Novara, Piedmont 28100, Italy

Casa di Cura La MaddalenaActive, not recruiting

Palermo, Sicily 90146, Italy

Ospedale Santa Maria AnnunziataActive, not recruiting

Bagno a Ripoli, Tuscany 50012, Italy

"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"Withdrawn

Verona, Veneto 37124, Italy

Nagoya City University HospitalRecruiting

Aichi, 467-8602, Japan

Chiba Cancer CenterRecruiting

Chiba, 260-8717, Japan

Hiroshima City Hiroshima Citizens HospitalRecruiting

Hiroshima, 730-8518, Japan

Sagara HospitalRecruiting

Kagoshima, 892-0833, Japan

Tokai University HospitalRecruiting

Kanagawa, 259-1193, Japan

Kyoto University HospitalRecruiting

Kyoto, 606-8507, Japan

National Hospital Organization Shikoku Cancer CenterRecruiting

Matsuyama, 791-0280, Japan

Saitama Medical University International Medical CenterRecruiting

Saitama, 350-1298, Japan

The Cancer Institute Hospital of JFCRRecruiting

Tokyo, 135-8550, Japan

King Hussein Cancer CenterActive, not recruiting

Amman, 11941, Jordan

University of Nairobi - Institute of Tropical and Infectious DiseasesRecruiting

Nairobi, Kenya

Hospital Civil de Guadalajara Fray Antonio AlcaldeActive, not recruiting

Guadalajara, Jalisco 44280, Mexico

OncoMedActive, not recruiting

Mexico City, Mexico CITY (federal District) 03100, Mexico

Centro Oncológico Hematológico RomaWithdrawn

Mexico City, Mexico CITY (federal District) 06700, Mexico

Hospital UniversitarioWithdrawn

Monterrey, Nuevo León 64460, Mexico

CENEIT OncologicosActive, not recruiting

Mexico City, 03100, Mexico

Sultan Qaboos Comprehensive Cancer Care & Research CenterRecruiting

Muscat, Oman

Centrum Onkologii im. Prof. Franciszka ?ukaszczykaActive, not recruiting

Bydgoszcz, 85-796, Poland

Uniwersyteckie Centrum KliniczneActive, not recruiting

Gda?sk, 80-214, Poland

Szpital Morski im.PCKWithdrawn

Gdynia, 81-519, Poland

Narodowy Instytut Onkologii Odzia? w GliwicachWithdrawn

Gliwice, 44-102, Poland

Przychodnia Lekarska KOMED, Roman KaraszewskiActive, not recruiting

Konin, 62-500, Poland

Szpital Wojewódzki im. Miko?aja KopernikaActive, not recruiting

Koszalin, 75-581, Poland

Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-CurieWithdrawn

Późna, 61-866, Poland

Centrum Onkologii Instytut im.M. Sklodowskiej-CurieActive, not recruiting

Warsaw, 02-781, Poland

National University HospitalActive, not recruiting

Singapore, 119228, Singapore

National Cancer CentreActive, not recruiting

Singapore, 169610, Singapore

Icon Cancer Centre Farrer ParkWithdrawn

Singapore, 217562, Singapore

Tan Tock Seng HospitalWithdrawn

Singapore, 308433, Singapore

Hopelands Cancer CentreRecruiting

Hilton, 3245, South Africa

Charlotte Maxeke Academic HospitalRecruiting

Johannesburg, 2193, South Africa

Medical Oncology Centre of RosebankActive, not recruiting

Johannesburg, 2196, South Africa

Limpopo Cancer Research InstituteActive, not recruiting

Polokwane, 0700, South Africa

Steve Biko Academic HospitalRecruiting

Pretoria, 0002, South Africa

Chris Hani Baragwanath Clinical Trial SiteActive, not recruiting

Soweto, 2013, South Africa

National Cancer CenterActive, not recruiting

Goyang-si, 10408, South Korea

Seoul National University HospitalActive, not recruiting

Seoul, 03080, South Korea

Severance Hospital, Yonsei University Health SystemActive, not recruiting

Seoul, 03722, South Korea

Asan Medical CenterCompleted

Seoul, 05505, South Korea

Gangnam Severance HospitalActive, not recruiting

Seoul, 06273, South Korea

Samsung Medical CenterActive, not recruiting

Seoul, 06351, South Korea

Seoul St Mary's HospitalActive, not recruiting

Seoul, 06591, South Korea

Complejo Hospitalario Universitario A Coruña (CHUAC)Recruiting

A Coruña, LA Coruna 15006, Spain

Hospital Universitari Dexeus - Grupo QuironsaludRecruiting

Barcelona, 08028, Spain

Hospital Universitari Vall d'HebronRecruiting

Barcelona, 08035, Spain

Hospital General Universitario Gregorio MarañonRecruiting

Madrid, 28007, Spain

Hospital Ramon y CajalRecruiting

Madrid, 28034, Spain

Hospital Universitario 12 de OctubreActive, not recruiting

Madrid, 28041, Spain

Hospital Clinico Universitario Virgen de la VictoriaRecruiting

Málaga, 29010, Spain

Hospital Universitario Virgen MacarenaRecruiting

Seville, 41009, Spain

National Taiwan Uni HospitalRecruiting

Taipei, 100, Taiwan

Tri-Service General HospitalRecruiting

Taipei, Taiwan

Chang Gung Memorial Hospital-LinkouRecruiting

Taoyuan County, 333, Taiwan

Abderrahmen Mami HospitalRecruiting

Aryanah, 2080, Tunisia

Taher Maamouri HospitalRecruiting

Nabeul, 8000, Tunisia

Habib Bourguiba HospitalRecruiting

Sfax, 3029, Tunisia

Farhat Hached HospitalRecruiting

Sousse, 4031, Tunisia

Institut Salah AzeizRecruiting

Tunis, 1006, Tunisia

Sakarya Training and Research HospitalActive, not recruiting

Adapazarı, 54290, Turkey (Türkiye)

Gulhane Training and Research HospitalWithdrawn

Ankara, 06010, Turkey (Türkiye)

Gazi University Medical FacultyActive, not recruiting

Ankara, 06500, Turkey (Türkiye)

Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi OnkolojiActive, not recruiting

Bakirkoy / Istanbul, 34147, Turkey (Türkiye)

Dicle University Faculty of MedicineActive, not recruiting

Diyarbakır, 21280, Turkey (Türkiye)

Medipol Mega Üniversite Hastanesi GöztepeActive, not recruiting

Istanbul, 34214, Turkey (Türkiye)

Izmir Ataturk Training and Research HospitalActive, not recruiting

Izmir, 35360, Turkey (Türkiye)

Medical Park Seyhan HospitalActive, not recruiting

Seyhan, 01140, Turkey (Türkiye)

Hacettepe Uni Medical Faculty HospitalActive, not recruiting

Sihhiye/Ankara, 06230, Turkey (Türkiye)

Uganda Cancer InstituteRecruiting

Kampala, 00256, Uganda

Belfast City HospitalWithdrawn

Belfast, BT9 7AB, United Kingdom

Blackpool Victoria HospitalRecruiting

Blackpool, FY3 8NR, United Kingdom

Colchester General HospitalRecruiting

Colchester, Essex, CO4 5JL, United Kingdom

Mount Vernon HospitalRecruiting

Northwood, HA6 2RN, United Kingdom

Nottingham City HospitalRecruiting

Nottingham, NG5 1PB, United Kingdom

Churchill HospitalRecruiting

Oxford, OX3 7LJ, United Kingdom