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NCT05894239PHASE3Recruiting

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

Hoffmann-La Roche

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

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

Interventions

DRUG

Inavolisib

DRUG

Phesgo

DRUG

Placebo

DRUG

Taxane-based Chemotherapy

DRUG

Optional Endocrine Therapy of Investigator's Choice

Interested in This Trial?

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Conditions

Metastatic Breast Cancer

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