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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
Sponsor: Hoffmann-La Roche
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).
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2023-09-08
Completion Date
2032-12-28
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Inavolisib
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
Phesgo
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
Placebo
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
Taxane-based Chemotherapy
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Optional Endocrine Therapy of Investigator's Choice
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.
Locations (192)
Banner Health MD Anderson AZ
Gilbert, Arizona, United States
Disney Family Cancer Center
Burbank, California, United States
City of Hope
Corona, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
Ellison Medical Institute
Los Angeles, California, United States
Georgetown Uni Hospital
Washington D.C., District of Columbia, United States
Medstar Research Institute
Hyattsville, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Renown Regional Medical Center
Reno, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Atrium Health
Charlotte, North Carolina, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Renovatio Clinical - El Paso
El Paso, Texas, United States
JPS Health Network
Fort Worth, Texas, United States
Lumi Research
Kingwood, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Swedish Medical Center
Seattle, 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
Instituto de Oncología de Rosario
Rosario, Argentina
Hospital Provincial del Centenario
Rosario, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, Argentina
Clínica Viedma
Viedma Rio Negro, Argentina
Blacktown Hospital
Blacktown, New South Wales, Australia
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Institut Jules Bordet
Anderlecht, Belgium
CHIREC
Auderghem, Belgium
CHU Brugmann (Victor Horta)
Brussels, Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium
GHdC Site Les Viviers
Charleroi, Belgium
CHU HELORA - Hôpital de la Louvière - Site Jolimont
Haine-Saint-Paul, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, Belgium
Clinique Ste-Elisabeth
Namur, Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Hospital do Câncer de Londrina
Londrina, Paraná, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor Amazônia
Porto Velho, Rondônia, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
Eastern Health - General Hospital
St. John's, Newfoundland and Labrador, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, Canada
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, Canada
Hopital du Saint Sacrement
Québec, Quebec, Canada
Allan Blair Cancer Center
Regina, Saskatchewan, Canada
Affiliated Hospital of Hebei University
Baoding, China
Beijing Cancer Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
Sichuan Provincial Cancer Hospital
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
Fujian Cancer Hospital
Fuzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Tumor Hospital
Harbin, China
Shandong Cancer Hospital
Jinan, China
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang, China
The Second Affiliated Hospital to Nanchang University
Nanchang, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China
Shantou Center Hospital
Shantou, China
Tianjin Cancer Hospital
Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Hubei Cancer Hospital
Wuhan, China
Clinica De La Costa
Barranquilla, Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., Colombia
Oncomedica S.A.
Montería, Colombia
Sociedad de Oncología y hematología del Cesar Ltda
Valledupar, Colombia
Tampere University Hospital
Tampere, Finland
Turku Uni Central Hospital
Turku, Finland
Institut Sainte Catherine
Avignon, France
Centre Hospitalier de La Cote Basque
Bayonne, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Centre Georges Francois Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Klinikum St. Marien
Amberg, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Marienhospital Bottrop gGmbH
Bottrop, Germany
Gynonco Düsseldorf, MVZ Medical Center GmbH
Düsseldorf, Germany
Frauenarztpraxis Dr. Apel, Dr. Kolpin
Erfurt, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, Germany
St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren
Münster, Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, Germany
Gynäkologie Kompetenzzentrum
Stralsund, Germany
Universitätsfrauenklinik Ulm
Ulm, Germany
Queen Mary Hospital
Hong Kong, Hong Kong