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
- Metastatic Breast Cancer
- Interventions
- Drug: Taxane-based ChemotherapyDrug: PlaceboDrug: Optional Endocrine Therapy of Investigator's Choice
- 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 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 Phesgo 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 (164)
Shandong Cancer Hospital
🇨🇳Jinan, China
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Farhat Hached Hospital
🇹🇳Sousse, Tunisia
Institut Salah Azeiz
🇹🇳Tunis, Tunisia
Hubei Cancer Hospital
🇨🇳Wuhan, China
Banner Health MD Anderson AZ
🇺🇸Gilbert, Arizona, United States
Disney Family Cancer Center
🇺🇸Burbank, California, United States
Ellison Institute of Technology
🇺🇸Los Angeles, California, United States
Georgetown Uni Hospital
🇺🇸Washington, 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
Fundación CENIT para la Investigación en Neurociencias
🇦🇷Buenos Aires, 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
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
GHdC Site Les Viviers
🇧🇪Charleroi, Belgium
Jessa Zkh (Campus Virga Jesse)
🇧🇪Hasselt, Belgium
Clinique Ste-Elisabeth
🇧🇪Namur, Belgium
Hospital Sao Rafael - HSR
🇧🇷Salvador, Bahia, Brazil
Crio - Centro Regional Integrado de Oncologia
🇧🇷Fortaleza, Ceará, Brazil
Hospital Araujo Jorge
🇧🇷Goiania, 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
🇧🇷Sao Paulo, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
🇧🇷Sao 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
Centre Hospitalier de l?Université de Montréal (CHUM)
🇨🇦Montreal, Quebec, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Hopital du Saint Sacrement
🇨🇦Quebec City, 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 City, China
Sichuan Provincial Cancer Hospital
🇨🇳Chengdu, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou City, China
Harbin Medical University Tumor Hospital
🇨🇳Harbin, 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 City, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan City, 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.
🇨🇴Monteria, 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 Oscar Lambret
🇫🇷Lille, France
Klinikum St. Marien
🇩🇪Amberg, Germany
Marienhospital Bottrop gGmbH
🇩🇪Bottrop, Germany
Gynonco Düsseldorf, MVZ Medical Center GmbH
🇩🇪Düsseldorf, Germany
Frauenarztpraxis Dr. Apel, Dr. Kolpin
🇩🇪Erfurt, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
🇩🇪Freiburg, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
🇩🇪München, Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
🇩🇪Saarbruecken, Germany
Gynäkologie Kompetenzzentrum
🇩🇪Stralsund, Germany
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Tuen Mun Hospital
🇭🇰Hong Kong, Hong Kong
Max Super Speciality Hospital
🇮🇳NEW Delhi Delhi, Delhi, India
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
🇮🇳Surat CITY, Gujarat, India
Artemis Hospital
🇮🇳Gurugram, Haryana, India
Tata Medical Center
🇮🇳Kolkata, WEST Bengal, India
I.R.S.T Srl IRCCS
🇮🇹Meldola, Emilia-Romagna, Italy
Ospedale San Giovanni Addolorata
🇮🇹Roma, Lazio, Italy
Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
🇮🇹Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
🇮🇹Milano, Lombardia, Italy
Ospedale San Gerardo
🇮🇹Monza, Lombardia, Italy
A.O.U. Maggiore della Carità
🇮🇹Novara, Piemonte, Italy
Casa di Cura La Maddalena
🇮🇹Palermo, Sicilia, Italy
Ospedale Santa Maria Annunziata
🇮🇹Bagno a Ripoli, Toscana, Italy
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
🇮🇹Verona, Veneto, Italy
King Hussein Cancer Center
🇯🇴Amman, Jordan
University of Nairobi - Institute of Tropical and Infectious Diseases
🇰🇪Nairobi, Kenya
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Civil de Guadalajara Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
OncoMed
🇲🇽Ciudad de México, Mexico CITY (federal District), Mexico
Centro Oncológico Hematológico Roma
🇲🇽Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario
🇲🇽Monterrey, Nuevo LEON, Mexico
CENEIT Oncologicos
🇲🇽Mexico City, Mexico
Sultan Qaboos Comprehensive Cancer Care & Research Center
🇴🇲Muscat, Oman
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
🇵🇱Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gda?sk, Poland
Szpital Morski im.PCK
🇵🇱Gdynia, Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach
🇵🇱Gliwice, Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
🇵🇱Konin, Poland
Szpital Wojewódzki im. Miko?aja Kopernika
🇵🇱Koszalin, Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
🇵🇱Pozna?, Poland
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
🇵🇱Warszawa, Poland
National University Hospital
🇸🇬Singapore, Singapore
National Cancer Centre
🇸🇬Singapore, Singapore
Icon Cancer Centre Farrer Park
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Hopelands Cancer Centre
🇿🇦Hilton, South Africa
Charlotte Maxeke Academic Hospital
🇿🇦Johannesburg, South Africa
Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, South Africa
Limpopo Cancer Research Institute
🇿🇦Polokwane, South Africa
Steve Biko Academic Hospital
🇿🇦Pretoria, South Africa
Chris Hani Baragwanath Clinical Trial Site
🇿🇦Soweto, South Africa
Complejo Hospitalario Universitario A Coruña (CHUAC)
🇪🇸A Coruña, LA Coruna, Spain
Hospital Universitari Dexeus - Grupo Quironsalud
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
National Taiwan Uni Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital-Linkou
🇨🇳Taoyuan County, Taiwan
Abderrahmen Mami Hospital
🇹🇳Ariana, Tunisia
Habib Bourguiba Hospital
🇹🇳Sfax, Tunisia
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
🇹🇷Bakirkoy / Istanbul, Turkey
Dicle University Faculty of Medicine
🇹🇷Diyarbakir, Turkey
Medipol Mega Üniversite Hastanesi Göztepe
🇹🇷Istanbul, Turkey
Katip Celebi University Ataturk Training and Research Hospital
🇹🇷Izmir, Turkey
Medical Park Seyhan Hospital
🇹🇷Seyhan, Turkey
Hacettepe Uni Medical Faculty Hospital
🇹🇷Sihhiye/Ankara, Turkey
Uganda Cancer Institute
🇺🇬Kampala, Uganda
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Colchester General Hospital
🇬🇧Colchester, Essex, United Kingdom
Mount Vernon Hospital
🇬🇧Northwood, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom