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
- Conditions
- Interventions
- Registration Number
- NCT05894239
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 230
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maintenance Therapy: Inavolisib plus Phesgo Phesgo Participants will be administered the treatments as outlined in the interventions section. Induction Therapy: Phesgo plus Taxane-Based Chemotherapy Phesgo Participants will be administered the treatments as outlined in the interventions section. Induction Therapy: Phesgo plus Taxane-Based Chemotherapy Taxane-based Chemotherapy Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Inavolisib plus Phesgo Inavolisib Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Inavolisib plus Phesgo Optional Endocrine Therapy of Investigator's Choice Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Placebo plus Phesgo Phesgo Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Placebo plus Phesgo Placebo Participants will be administered the treatments as outlined in the interventions section. Maintenance Therapy: Placebo plus Phesgo Optional Endocrine Therapy of Investigator's Choice Participants will be administered the treatments as outlined in the interventions section.
- Primary Outcome Measures
Name Time Method Investigator-Assessed Progression-Free Survival (PFS) Up to approximately 40 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 111 months Investigator-Assessed Objective Response Rate (ORR) Up to approximately 111 months Investigator-Assessed Duration of Response (DOR) Up to approximately 111 months Investigator-Assessed Clinical Benefit Rate (CBR) Up to approximately 111 months Investigator-Assessed PFS2 Up to approximately 111 months Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL) Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit every 6 months (up to 111 months). Each cycle is 21 days. Assessed through the use of the Functional (Role, Physical) and Global Health Status (GHS)/Quality of Life (QoL) scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Percentage of Participants with Adverse Events Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days. Plasma Concentration of Inavolisib at Specified Timepoints Day 1 of Cycles 1 and 4. Each cycle is 21 days.
Trial Locations
- Locations (148)
Lawrence J. Ellison Institute for Transformative Medicine
🇺🇸Los Angeles, California, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan City, China
Oncomedica S.A.
🇨🇴Monteria, Colombia
The First Hospital of Jilin University
🇨🇳Changchun City, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou City, China
Hubei Cancer Hospital
🇨🇳Wuhan, China
Sichuan Provincial Cancer Hospital
🇨🇳Chengdu, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China
Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy
🇨🇳Harbin, China
Shandong Cancer Hospital
🇨🇳Jinan, China
The First Affiliated Hospital to Henan University of Science and Technology
🇨🇳Luoyang City, China
Guangxi Cancer Hospital of Guangxi Medical University
🇨🇳Nanning City, China
The Second Affiliated Hospital to Nanchang University
🇨🇳Nanchang, China
Shantou Center Hospital
🇨🇳Shantou City, China
Tianjin Cancer Hospital; Department of Breast Oncology
🇨🇳Tianjin, China
Institut Sainte Catherine
🇫🇷Avignon, France
Turku Uni Central Hospital; Oncology Clinics
🇫🇮Turku, Finland
Klinikum St. Marien; Frauenklinik
🇩🇪Amberg, Germany
Queen Mary Hospital; Dept. of Clinical Oncology
🇭🇰Hong Kong, Hong Kong
Tuen Mun Hospital; Clinical Oncology
🇭🇰Hong Kong, Hong Kong
Ospedale San Giovanni Addolorata; Oncologia
🇮🇹Roma, Lazio, Italy
Ospedale San Raffaele; Medical Oncology
🇮🇹Milano, Lombardia, Italy
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Civil de Guadalajara Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Zambrano Hellion TecSalud
🇲🇽Monterrey, Nuevo LEON, Mexico
CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
🇲🇽Mexico City, Mexico
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
🇵🇱Gdansk, Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
🇵🇱Gliwice, Poland
Icon Cancer Centre Farrer Park
🇸🇬Singapore, Singapore
Hopelands Cancer Centre
🇿🇦Hilton, South Africa
Charlotte Maxeke Academic Hospital
🇿🇦Johannesburg, South Africa
Medical Oncology Centre of Rosebank; Oncology
🇿🇦Johannesburg, South Africa
Limpopo Cancer Research Institute
🇿🇦Polokwane, South Africa
Steve Biko Academic Hospital; Oncology
🇿🇦Pretoria, South Africa
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
🇪🇸A Coruña, LA Coruña, Spain
Chris Hani Baragwanath Clinical Trial Site
🇿🇦Soweto, South Africa
Hospital Universitario 12 de Octubre; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
🇪🇸Malaga, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
🇪🇸Sevilla, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
🇪🇸Madrid, Spain
National Taiwan Uni Hospital; General Surgery
🇨🇳Taipei, Taiwan
Tri-Service General Hospital; Department of Haematology and Oncology
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital-Linkou; Dept of Oncology
🇨🇳Taoyuan County, Taiwan
Dicle University Faculty of Medicine
🇹🇷Diyarbakir, Turkey
Medical Park Seyhan Hospital; Oncology Department
🇹🇷Seyhan, Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
🇹🇷Sihhiye/Ankara, Turkey
Colchester General Hospital
🇬🇧Colchester, Essex, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
🇬🇧Oxford, United Kingdom
Nottingham City Hospital; Oncology
🇬🇧Nottingham, United Kingdom
Mount Vernon Hospital; Centre For Cancer Treatment
🇬🇧Northwood, United Kingdom
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Centro Oncologico Korben; Oncology
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Instituto de Oncología de Rosario
🇦🇷Rosario, Argentina
Kinghorn Cancer Centre; St Vincents Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Blacktown Hospital
🇦🇺Blacktown, New South Wales, Australia
Gosford Hospital; Cancer Care Services
🇦🇺Gosford, New South Wales, Australia
University of the Sunshine Coast
🇦🇺Sippy Downs, Queensland, Australia
Sir Charles Gairdner Hospital; Medical Oncology
🇦🇺Perth, Western Australia, Australia
GHdC Site Notre Dame
🇧🇪Charleroi, Belgium
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
Clinique Ste-Elisabeth
🇧🇪Namur, Belgium
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
🇧🇷Goiania, GO, Brazil
Hospital do Câncer de Londrina
🇧🇷Londrina, PR, Brazil
Hospital de Amor Amazônia
🇧🇷Porto Velho, RO, Brazil
Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos
🇧🇷Barretos, SP, Brazil
Tom Baker Cancer Centre-Calgary
🇨🇦Calgary, Alberta, Canada
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
🇧🇷Sao Paulo, SP, Brazil
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Affiliated Hospital of Hebei University; Department of medical oncology
🇨🇳Baoding, China
Hopital du Saint Sacrement
🇨🇦Quebec City, Quebec, Canada
Beijing Cancer Hospital
🇨🇳Beijing, China
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Disney Family Cancer Center
🇺🇸Burbank, California, United States
Lumi Research
🇺🇸Kingwood, Texas, United States
Kadlec Clinic Hematology and Oncology
🇺🇸Kennewick, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Marienhospital Bottrop gGmbH; Department of Gynecology and Obstetrics
🇩🇪Bottrop, Germany
Gynonco Düsseldorf, MVZ Medical Center GmbH
🇩🇪Düsseldorf, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
🇩🇪München, Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
🇩🇪Saarbruecken, Germany
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
🇮🇳Surat CITY, Gujarat, India
Tampere University Hospital; Dept of Oncology
🇫🇮Tampere, Finland
Centre Hospitalier de La Cote Basque; Oncologie
🇫🇷Bayonne, France
Frauenarztpraxis Dr. Apel, Dr. Kolpin
🇩🇪Erfurt, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
🇩🇪Freiburg, Germany
Artemis Hospital
🇮🇳Gurugram, Haryana, India
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
🇵🇱Bydgoszcz, Poland
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk
🇵🇱Warszawa, Poland
Tata Medical Center
🇮🇳Kolkata, WEST Bengal, India
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
🇮🇹Verona, Veneto, Italy
Clinica De La Costa
🇨🇴Barranquilla, Colombia
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
🇮🇹Milano, Lombardia, Italy
A.O.U. Maggiore della Carità
🇮🇹Novara, Piemonte, Italy
Casa di Cura La Maddalena; Oncologia Medica
🇮🇹Palermo, Sicilia, Italy
Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny
🇵🇱Gdynia, Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
🇵🇱Konin, Poland
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
🇵🇱Koszalin, Poland
National University Hospital; National University Cancer Institute, Singapore (NCIS)
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital; Oncology
🇸🇬Singapore, Singapore
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
🇮🇹Milano, Lombardia, Italy
Ospedale San Gerardo; Centro Di Ricerca di Fase I ? Piano 8 ? Settore C
🇮🇹Monza, Lombardia, Italy
Ospedale Santa Maria Annunziata; Oncologia
🇮🇹Bagno a Ripoli, Toscana, Italy
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
🇨🇴Bogota, D.C., Colombia
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
🇩🇪Stralsund, Germany
Centro Oncológico Hematológico Roma
🇲🇽Mexico City, Mexico CITY (federal District), Mexico
National Cancer Centre; Medical Oncology
🇸🇬Singapore, Singapore
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Medstar Research Institute
🇺🇸Hyattsville, Maryland, United States
Georgetown Uni Hospital; 4-N Main Hospital
🇺🇸Washington, District of Columbia, United States
Medipol Mega Üniversite Hastanesi Göztepe
🇹🇷Istanbul, Turkey
Hospital Provincial del Centenario
🇦🇷Rosario, Argentina
Hospital Sao Rafael - HSR
🇧🇷Salvador, BA, Brazil
Hospital do Cancer de Pernambuco - HCP
🇧🇷Recife, PE, Brazil
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
OncoMed; Supportive Care
🇲🇽Ciudad de México, Mexico CITY (federal District), Mexico
Jessa Zkh (Campus Virga Jesse)
🇧🇪Hasselt, Belgium
Crio - Centro Regional Integrado de Oncologia
🇧🇷Fortaleza, CE, Brazil
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, RS, Brazil
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
🇹🇷Bakirkoy / Istanbul, Turkey
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
🇦🇷San Juan, Argentina
Hôpital du Sacré-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Banner Health MD Anderson AZ
🇺🇸Gilbert, Arizona, United States
Monash Health
🇦🇺Clayton, Victoria, Australia
Eastern Health - General Hospital
🇨🇦St. John's, Newfoundland and Labrador, Canada
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao Paulo, SP, Brazil
Fundación CENIT para la Investigación en Neurociencias
🇦🇷Buenos Aires, Argentina
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Allan Blair Cancer Center
🇨🇦Regina, Saskatchewan, Canada
Zhejiang Cancer Hospital; Breast Surgery
🇨🇳Hangzhou City, China
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
I.R.S.T Srl IRCCS; Oncologia Medica
🇮🇹Meldola, Emilia-Romagna, Italy
Clínica Viedma
🇦🇷Viedma Rio Negro, Argentina
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montreal, Quebec, Canada