RecruitingRecruiting
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
NCT05894239 · Hoffmann-La Roche
In plain English
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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
About this study
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
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
Study design
Enrollment target: 230 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-09-08
Estimated completion: 2032-12-28
Last updated: 2026-05-29
Interventions
Drug: InavolisibDrug: PhesgoDrug: PlaceboDrug: Taxane-based ChemotherapyDrug: Optional Endocrine Therapy of Investigator's Choice
Primary outcomes
- • Investigator-Assessed Progression-Free Survival (PFS) (Up to approximately 40 months)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WO44263 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
ContactFastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (192)
Banner Health MD Anderson AZRecruiting
Gilbert, Arizona, United States
Disney Family Cancer CenterRecruiting
Burbank, California, United States
City of HopeRecruiting
Corona, California, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
City of Hope at Irvine LennarRecruiting
Irvine, California, United States
Ellison Institute of TechnologyRecruiting
Los Angeles, California, United States
Georgetown Uni HospitalRecruiting
Washington D.C., District of Columbia, United States
Medstar Research InstituteRecruiting
Hyattsville, Maryland, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Renown Regional Medical CenterWithdrawn
Reno, Nevada, United States
Hackensack University Medical CenterActive Not Recruiting
Hackensack, New Jersey, United States
Atrium HealthRecruiting
Charlotte, North Carolina, United States
Hightower ClinicalWithdrawn
Oklahoma City, Oklahoma, United States
Renovatio Clinical - El PasoRecruiting
El Paso, Texas, United States
JPS Health NetworkRecruiting
Fort Worth, Texas, United States
Lumi ResearchWithdrawn
Kingwood, Texas, United States
Renovatio ClinicalRecruiting
The Woodlands, Texas, United States
Kadlec Clinic Hematology and OncologyRecruiting
Kennewick, Washington, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.LActive Not Recruiting
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Centro Oncologico KorbenActive Not Recruiting
Ciudad Autonoma Buenos Aires, Argentina
Instituto de Oncología de RosarioActive Not Recruiting
Rosario, Argentina
Hospital Provincial del CentenarioActive Not Recruiting
Rosario, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion ClinicaRecruiting
San Juan, Argentina
Clínica ViedmaWithdrawn
Viedma Rio Negro, Argentina
Blacktown HospitalActive Not Recruiting
Blacktown, New South Wales, Australia
Kinghorn Cancer CentreActive Not Recruiting
Darlinghurst, New South Wales, Australia
Gosford HospitalActive Not Recruiting
Gosford, New South Wales, Australia
University of the Sunshine CoastActive Not Recruiting
Sippy Downs, Queensland, Australia
Monash HealthCompleted
Clayton, Victoria, Australia
Sir Charles Gairdner HospitalCompleted
Perth, Western Australia, Australia
Institut Jules BordetWithdrawn
Anderlecht, Belgium
CHIRECWithdrawn
Auderghem, Belgium
CHU Brugmann (Victor Horta)Withdrawn
Brussels, Belgium
Cliniques Universitaires St-LucWithdrawn
Brussels, Belgium
GHdC Site Les ViviersWithdrawn
Charleroi, Belgium
CHU HELORA - Hôpital de la Louvière - Site JolimontRecruiting
Haine-Saint-Paul, Belgium
Jessa Zkh (Campus Virga Jesse)Withdrawn
Hasselt, Belgium
Clinique Ste-ElisabethWithdrawn
Namur, Belgium
Crio - Centro Regional Integrado de OncologiaRecruiting
Fortaleza, Ceará, Brazil
Hospital Sao Rafael - HSRRecruiting
Salvador, Estado de Bahia, Brazil
Hospital Araujo JorgeRecruiting
Goiânia, Goiás, Brazil
Hospital do Câncer de LondrinaRecruiting
Londrina, Paraná, Brazil
Hospital do Cancer de Pernambuco - HCPRecruiting
Recife, Pernambuco, Brazil
Santa Casa de Misericordia de Porto AlegreActive Not Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRSRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor AmazôniaRecruiting
Porto Velho, Rondônia, Brazil
Hospital de Cancer de BarretosRecruiting
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
São Paulo, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria LtdaRecruiting
São Paulo, São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Center-CalgaryRecruiting
Calgary, Alberta, Canada
The Moncton HospitalRecruiting
Moncton, New Brunswick, Canada
Eastern Health - General HospitalRecruiting
St. John's, Newfoundland and Labrador, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de MontrealRecruiting
Montreal, Quebec, Canada
Centre Hospitalier de l?Université de Montréal (CHUM)Recruiting
Montreal, Quebec, Canada
Hopital du Saint SacrementRecruiting
Québec, Quebec, Canada
Allan Blair Cancer CenterRecruiting
Regina, Saskatchewan, Canada
Affiliated Hospital of Hebei UniversityRecruiting
Baoding, China
Beijing Cancer HospitalRecruiting
Beijing, China
The First Hospital of Jilin UniversityRecruiting
Changchun, China
Sichuan Provincial Cancer HospitalRecruiting
Chengdu, China
Sichuan Provincial People's HospitalActive Not Recruiting
Chengdu, China
Fujian Cancer HospitalRecruiting
Fuzhou, China
Zhejiang Cancer HospitalRecruiting
Hangzhou, China
Harbin Medical University Tumor HospitalActive Not Recruiting
Harbin, China
Shandong Cancer HospitalRecruiting
Jinan, China
The First Affiliated Hospital to Henan University of Science and TechnologyRecruiting
Luoyang, China
The Second Affiliated Hospital to Nanchang UniversityActive Not Recruiting
Nanchang, China
Guangxi Cancer Hospital of Guangxi Medical UniversityActive Not Recruiting
Nanning, China
Shantou Center HospitalWithdrawn
Shantou, China
Tianjin Cancer HospitalRecruiting
Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, China
Hubei Cancer HospitalActive Not Recruiting
Wuhan, China
Clinica De La CostaWithdrawn
Barranquilla, Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento AnguloRecruiting
Bogota, D.C., Colombia
Oncomedica S.A.Recruiting
Montería, Colombia
Sociedad de Oncología y hematología del Cesar LtdaRecruiting
Valledupar, Colombia
Tampere University HospitalWithdrawn
Tampere, Finland
Turku Uni Central HospitalWithdrawn
Turku, Finland
Institut Sainte CatherineRecruiting
Avignon, France
Centre Hospitalier de La Cote BasqueRecruiting
Bayonne, France
Polyclinique Bordeaux Nord AquitaineRecruiting
Bordeaux, France
Centre Georges Francois LeclercRecruiting
Dijon, France
Centre Oscar LambretRecruiting
Lille, France
Klinikum St. MarienRecruiting
Amberg, Germany
HELIOS Klinikum Berlin-BuchRecruiting
Berlin, Germany
Marienhospital Bottrop gGmbHRecruiting
Bottrop, Germany
Gynonco Düsseldorf, MVZ Medical Center GmbHWithdrawn
Düsseldorf, Germany
Frauenarztpraxis Dr. Apel, Dr. KolpinRecruiting
Erfurt, Germany
Universitätsklinikum ErlangenRecruiting
Erlangen, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbRRecruiting
Freiburg im Breisgau, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus InnenstadtRecruiting
München, Germany
St. Franziskus Hospital Münster;Studiensekretariat der onkologischen ZentrenRecruiting
Münster, Germany
Caritas Klinik St. Theresia -Frauenklinik BrustzentrumRecruiting
Saarbrücken, Germany
Gynäkologie KompetenzzentrumWithdrawn
Stralsund, Germany
Universitätsfrauenklinik UlmRecruiting
Ulm, Germany
Queen Mary HospitalRecruiting
Hong Kong, Hong Kong
Tuen Mun HospitalRecruiting
Hong Kong, Hong Kong
Gujarat Cancer & Research Inst.Recruiting
Ahmedabad, Gujarat, India
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)Recruiting
Surat, Gujarat, India
Artemis HospitalRecruiting
Gurugram, Haryana, India
Sir H. N. Reliance Foundation Hospital and Research CentreRecruiting
Mumbai, Maharashtra, India
National Cancer InstituteRecruiting
Nagpur, Maharashtra, India
Max Super Speciality HospitalRecruiting
NEW Delhi Delhi, National Capital Territory of Delhi, India
Tata Medical CenterRecruiting
Kolkata, West Bengal, India
I.R.S.T Srl IRCCSActive Not Recruiting
Meldola, Emilia-Romagna, Italy
Ospedale San Giovanni AddolorataActive Not Recruiting
Rome, Lazio, Italy
Ospedale San RaffaeleActive Not Recruiting
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int)Active Not Recruiting
Milan, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO)Active Not Recruiting
Milan, Lombardy, Italy
Ospedale San GerardoActive Not Recruiting
Monza, Lombardy, Italy
A.O.U. Maggiore della CaritàActive Not Recruiting
Novara, Piedmont, Italy
Casa di Cura La MaddalenaActive Not Recruiting
Palermo, Sicily, Italy
Ospedale Santa Maria AnnunziataActive Not Recruiting
Bagno a Ripoli, Tuscany, Italy
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"Withdrawn
Verona, Veneto, Italy
Nagoya City University HospitalRecruiting
Aichi, Japan
Chiba Cancer CenterRecruiting
Chiba, Japan
Hiroshima City Hiroshima Citizens HospitalRecruiting
Hiroshima, Japan
Sagara HospitalRecruiting
Kagoshima, Japan
Tokai University HospitalRecruiting
Kanagawa, Japan
Kyoto University HospitalRecruiting
Kyoto, Japan
National Hospital Organization Shikoku Cancer CenterRecruiting
Matsuyama, Japan
Saitama Medical University International Medical CenterRecruiting
Saitama, Japan
The Cancer Institute Hospital of JFCRRecruiting
Tokyo, Japan
King Hussein Cancer CenterActive Not Recruiting
Amman, Jordan
University of Nairobi - Institute of Tropical and Infectious DiseasesRecruiting
Nairobi, Kenya
Hospital Civil de Guadalajara Fray Antonio AlcaldeActive Not Recruiting
Guadalajara, Jalisco, Mexico
OncoMedActive Not Recruiting
Mexico City, Mexico CITY (federal District), Mexico
Centro Oncológico Hematológico RomaRecruiting
Mexico City, Mexico CITY (federal District), Mexico
Hospital UniversitarioWithdrawn
Monterrey, Nuevo León, Mexico
CENEIT OncologicosRecruiting
Mexico City, Mexico
Sultan Qaboos Comprehensive Cancer Care & Research CenterRecruiting
Muscat, Oman
Centrum Onkologii im. Prof. Franciszka ?ukaszczykaActive Not Recruiting
Bydgoszcz, Poland
Uniwersyteckie Centrum KliniczneActive Not Recruiting
Gda?sk, Poland
Szpital Morski im.PCKActive Not Recruiting
Gdynia, Poland
Narodowy Instytut Onkologii Odzia? w GliwicachWithdrawn
Gliwice, Poland
Przychodnia Lekarska KOMED, Roman KaraszewskiRecruiting
Konin, Poland
Szpital Wojewódzki im. Miko?aja KopernikaActive Not Recruiting
Koszalin, Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-CurieRecruiting
Późna, Poland
Centrum Onkologii Instytut im.M. Sklodowskiej-CurieActive Not Recruiting
Warsaw, Poland
National University HospitalRecruiting
Singapore, Singapore
National Cancer CentreCompleted
Singapore, Singapore
Icon Cancer Centre Farrer ParkWithdrawn
Singapore, Singapore
Tan Tock Seng HospitalWithdrawn
Singapore, Singapore
Hopelands Cancer CentreRecruiting
Hilton, South Africa
Charlotte Maxeke Academic HospitalRecruiting
Johannesburg, South Africa
Medical Oncology Centre of RosebankActive Not Recruiting
Johannesburg, South Africa
Limpopo Cancer Research InstituteActive Not Recruiting
Polokwane, South Africa
Steve Biko Academic HospitalRecruiting
Pretoria, South Africa
Chris Hani Baragwanath Clinical Trial SiteActive Not Recruiting
Soweto, South Africa
National Cancer CenterActive Not Recruiting
Goyang-si, South Korea
Seoul National University HospitalActive Not Recruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemActive Not Recruiting
Seoul, South Korea
Asan Medical CenterCompleted
Seoul, South Korea
Gangnam Severance HospitalActive Not Recruiting
Seoul, South Korea
Samsung Medical CenterActive Not Recruiting
Seoul, South Korea
Seoul St Mary's HospitalActive Not Recruiting
Seoul, South Korea
Complejo Hospitalario Universitario A Coruña (CHUAC)Recruiting
A Coruña, LA Coruna, Spain
Hospital Universitari Dexeus - Grupo QuironsaludRecruiting
Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital General Universitario Gregorio MarañonRecruiting
Madrid, Spain
Hospital Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreActive Not Recruiting
Madrid, Spain
Hospital Clinico Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
National Taiwan Uni HospitalRecruiting
Taipei, Taiwan
Tri-Service General HospitalRecruiting
Taipei, Taiwan
Chang Gung Memorial Hospital-LinkouRecruiting
Taoyuan County, Taiwan
Abderrahmen Mami HospitalRecruiting
Aryanah, Tunisia
Taher Maamouri HospitalRecruiting
Nabeul, Tunisia
Habib Bourguiba HospitalRecruiting
Sfax, Tunisia
Farhat Hached HospitalRecruiting
Sousse, Tunisia
Institut Salah AzeizRecruiting
Tunis, Tunisia
Sakarya Training and Research HospitalActive Not Recruiting
Adapazarı, Turkey (Türkiye)
Gulhane Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Gazi University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi OnkolojiRecruiting
Bakirkoy / Istanbul, Turkey (Türkiye)
Dicle University Faculty of MedicineRecruiting
Diyarbakır, Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi GöztepeActive Not Recruiting
Istanbul, Turkey (Türkiye)
Izmir Ataturk Training and Research HospitalActive Not Recruiting
Izmir, Turkey (Türkiye)
Medical Park Seyhan HospitalActive Not Recruiting
Seyhan, Turkey (Türkiye)
Hacettepe Uni Medical Faculty HospitalRecruiting
Sihhiye/Ankara, Turkey (Türkiye)
Uganda Cancer InstituteRecruiting
Kampala, Uganda
Belfast City HospitalWithdrawn
Belfast, United Kingdom
Blackpool Victoria HospitalRecruiting
Blackpool, United Kingdom
Colchester General HospitalRecruiting
Colchester, Essex, United Kingdom
Mount Vernon HospitalRecruiting
Northwood, United Kingdom
Nottingham City HospitalRecruiting
Nottingham, United Kingdom
Churchill HospitalRecruiting
Oxford, United Kingdom