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 (INAVO122)
May 27, 2026 updated by: Hoffmann-La Roche
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
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).
Study Overview
Status
Status
Recruiting
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Interventional
Enrollment (Estimated)
Enrollment
230
Phase
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
Study Contact
- Name: Reference Study ID Number: WO44263 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Study Contact Backup
- Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Study Locations
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Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
- Active, not recruiting
- Centro Oncologico Korben
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Rosario, Argentina, S2000KZE
- Active, not recruiting
- Instituto de Oncologia de Rosario
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Rosario, Argentina, S2002KDS
- Active, not recruiting
- Hospital Provincial del Centenario
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San Juan, Argentina, J5400DIL
- Recruiting
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
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Viedma Rio Negro, Argentina, R8500ACE
- Withdrawn
- Clinica Viedma
-
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Ciudad Autónoma de BuenosAires
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Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1113AAE
- Active, not recruiting
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L
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New South Wales
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Blacktown, New South Wales, Australia, NSW 2148
- Active, not recruiting
- Blacktown Hospital
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Darlinghurst, New South Wales, Australia, 2010
- Active, not recruiting
- Kinghorn Cancer Centre
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Gosford, New South Wales, Australia, 2250
- Active, not recruiting
- Gosford Hospital
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Queensland
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Sippy Downs, Queensland, Australia, 4556
- Active, not recruiting
- University of the Sunshine Coast
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Victoria
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Clayton, Victoria, Australia, 3168
- Completed
- Monash Health
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Western Australia
-
Perth, Western Australia, Australia, 6009
- Completed
- Sir Charles Gairdner Hospital
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Anderlecht, Belgium, 1070
- Withdrawn
- Institut Jules Bordet
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Auderghem, Belgium, 1160
- Withdrawn
- CHIREC
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Brussels, Belgium, 1200
- Withdrawn
- Cliniques Universitaires St-Luc
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Brussels, Belgium, 1020
- Withdrawn
- CHU Brugmann (Victor Horta)
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Charleroi, Belgium, 6000
- Withdrawn
- GHdC Site Les Viviers
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Haine-Saint-Paul, Belgium, 7100
- Recruiting
- CHU HELORA - Hôpital de la Louvière - Site Jolimont
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Hasselt, Belgium, 3500
- Withdrawn
- Jessa Zkh (Campus Virga Jesse)
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Namur, Belgium, 5000
- Withdrawn
- Clinique Ste-Elisabeth
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Ceará
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Fortaleza, Ceará, Brazil, 60336-232
- Recruiting
- Crio - Centro Regional Integrado de Oncologia
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Estado de Bahia
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Salvador, Estado de Bahia, Brazil, 41253-190
- Recruiting
- Hospital Sao Rafael - HSR
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Goiás
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Goiânia, Goiás, Brazil, 74605-070
- Recruiting
- Hospital Araujo Jorge
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Paraná
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Londrina, Paraná, Brazil, 86015-520
- Recruiting
- Hospital do Cancer de Londrina
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Pernambuco
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Recife, Pernambuco, Brazil, 50040-000
- Recruiting
- Hospital do Cancer de Pernambuco - HCP
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
- Active, not recruiting
- Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Recruiting
- Hospital Sao Lucas - PUCRS
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Rondônia
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Porto Velho, Rondônia, Brazil, 76834-899
- Recruiting
- Hospital de Amor Amazônia
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São Paulo
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Barretos, São Paulo, Brazil, 14784-400
- Recruiting
- Hospital de Cancer de Barretos
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São Paulo, São Paulo, Brazil, 01246-000
- Recruiting
- Instituto do Cancer do Estado de Sao Paulo - ICESP
-
São Paulo, São Paulo, Brazil, 01317-001
- Recruiting
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Recruiting
- Arthur J.E. Child Comprehensive Cancer Center-Calgary
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
- Recruiting
- The Moncton Hospital
-
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Recruiting
- Eastern Health - General Hospital
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Recruiting
- Jewish General Hospital
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Montreal, Quebec, Canada, H4J 1C5
- Recruiting
- Hopital du Sacre-Coeur de Montreal
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Montreal, Quebec, Canada, PO 25223
- Recruiting
- Centre Hospitalier de l?Université de Montréal (CHUM)
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Québec, Quebec, Canada, G1S 4L8
- Recruiting
- Hopital du Saint Sacrement
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Recruiting
- Allan Blair Cancer Center
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-
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Baoding, China, 071000
- Recruiting
- Affiliated Hospital of Hebei University
-
Beijing, China, 100142
- Recruiting
- Beijing Cancer hospital
-
Changchun, China, 130021
- Recruiting
- The First Hospital of Jilin University
-
Chengdu, China, 610041
- Recruiting
- Sichuan Provincial Cancer Hospital
-
Chengdu, China, 610072
- Active, not recruiting
- Sichuan Provincial People'S Hospital
-
Fuzhou, China, 350014
- Recruiting
- Fujian Cancer Hospital
-
Hangzhou, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
Harbin, China, 150049
- Active, not recruiting
- Harbin Medical University Tumor Hospital
-
Jinan, China, 250117
- Recruiting
- Shandong Cancer Hospital
-
Luoyang, China, 471003
- Recruiting
- The First Affiliated Hospital to Henan University of Science and Technology
-
Nanchang, China, 330006
- Active, not recruiting
- The Second Affiliated Hospital to Nanchang University
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Nanning, China, 530021
- Active, not recruiting
- Guangxi Cancer Hospital of Guangxi Medical University
-
Shantou, China, 515031
- Withdrawn
- Shantou Center Hospital
-
Tianjin, China, 300000
- Recruiting
- Tianjin Cancer Hospital
-
Wuhan, China, 430022
- Recruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
Wuhan, China, 430079
- Active, not recruiting
- Hubei Cancer Hospital
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Barranquilla, Colombia, 080020
- Withdrawn
- Clinica de la Costa
-
Bogota, D.C., Colombia, 110131
- Recruiting
- Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
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Montería, Colombia, 230002
- Recruiting
- Oncomedica S.A.
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Valledupar, Colombia, 200001
- Recruiting
- Sociedad de Oncología y hematología del Cesar Ltda
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Tampere, Finland, 33520
- Withdrawn
- Tampere University Hospital
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Turku, Finland, 20520
- Withdrawn
- Turku Uni Central Hospital
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Avignon, France, 84082
- Recruiting
- Institut Sainte Catherine
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Bayonne, France, 64109
- Recruiting
- Centre Hospitalier de la Cote Basque
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Bordeaux, France, 33300
- Recruiting
- Polyclinique Bordeaux Nord Aquitaine
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Dijon, France, 21000
- Recruiting
- Centre Georges François Leclerc
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Lille, France, 59020
- Recruiting
- Centre Oscar Lambret
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Amberg, Germany, 92224
- Recruiting
- Klinikum St. Marien
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Berlin, Germany, 13125
- Recruiting
- Helios Klinikum Berlin-Buch
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Bottrop, Germany, 46236
- Recruiting
- Marienhospital Bottrop gGmbH
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Düsseldorf, Germany, 40235
- Withdrawn
- Gynonco Düsseldorf, MVZ Medical Center GmbH
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Erfurt, Germany, 99084
- Recruiting
- Frauenarztpraxis Dr. Apel, Dr. Kolpin
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Erlangen, Germany, 91054
- Recruiting
- Universitätsklinikum Erlangen
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Freiburg im Breisgau, Germany, 79110
- Recruiting
- Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
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München, Germany, 80336
- Recruiting
- Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
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Münster, Germany, 48145
- Recruiting
- St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren
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Saarbrücken, Germany, 66113
- Recruiting
- Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
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Stralsund, Germany, 18439
- Withdrawn
- Gynäkologie Kompetenzzentrum
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Ulm, Germany, 89075
- Recruiting
- Universitätsfrauenklinik Ulm
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Hong Kong, Hong Kong
- Recruiting
- Queen Mary Hospital
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Hong Kong, Hong Kong
- Recruiting
- Tuen Mun Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380016
- Recruiting
- Gujarat Cancer & Research Inst.
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Surat, Gujarat, India, 395007
- Recruiting
- Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
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Haryana
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Gurugram, Haryana, India, 122001
- Recruiting
- Artemis Hospital
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Maharashtra
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Mumbai, Maharashtra, India, 400004
- Recruiting
- Sir H. N. Reliance Foundation Hospital and Research Centre
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Nagpur, Maharashtra, India, 441108
- Recruiting
- National Cancer Institute
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National Capital Territory of Delhi
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NEW Delhi Delhi, National Capital Territory of Delhi, India, 110092
- Recruiting
- Max Super Speciality Hospital
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West Bengal
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Kolkata, West Bengal, India, 700160
- Recruiting
- Tata Medical Center
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italy, 47014
- Active, not recruiting
- I.R.S.T Srl IRCCS
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Lazio
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Rome, Lazio, Italy, 00185
- Active, not recruiting
- Ospedale San Giovanni Addolorata
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Lombardy
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Milan, Lombardy, Italy, 20132
- Active, not recruiting
- Ospedale San Raffaele
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Milan, Lombardy, Italy, 20133
- Active, not recruiting
- Irccs Istituto Nazionale Dei Tumori (Int)
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Milan, Lombardy, Italy, 20141
- Active, not recruiting
- Irccs Istituto Europeo di Oncologia (IEO)
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Monza, Lombardy, Italy, 20900
- Active, not recruiting
- Ospedale San Gerardo
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Piedmont
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Novara, Piedmont, Italy, 28100
- Active, not recruiting
- A.O.U. Maggiore della Carita
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Sicily
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Palermo, Sicily, Italy, 90146
- Active, not recruiting
- Casa di Cura La Maddalena
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Tuscany
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Bagno a Ripoli, Tuscany, Italy, 50012
- Active, not recruiting
- Ospedale Santa Maria Annunziata
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Veneto
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Verona, Veneto, Italy, 37124
- Withdrawn
- "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
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Aichi, Japan, 467-8602
- Recruiting
- Nagoya City University Hospital
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Chiba, Japan, 260-8717
- Recruiting
- Chiba cancer center
-
Hiroshima, Japan, 730-8518
- Recruiting
- Hiroshima City Hiroshima Citizens Hospital
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Kagoshima, Japan, 892-0833
- Recruiting
- Sagara Hospital
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Kanagawa, Japan, 259-1193
- Recruiting
- Tokai University Hospital
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Kyoto, Japan, 606-8507
- Recruiting
- Kyoto University Hospital
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Matsuyama, Japan, 791-0280
- Recruiting
- National Hospital Organization Shikoku Cancer Center
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Saitama, Japan, 350-1298
- Recruiting
- Saitama Medical University International Medical Center
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Tokyo, Japan, 135-8550
- Recruiting
- The Cancer Institute Hospital of JFCR
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-
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Amman, Jordan, 11941
- Active, not recruiting
- King Hussein Cancer Center
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-
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Nairobi, Kenya
- Recruiting
- University of Nairobi - Institute of Tropical and Infectious Diseases
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Mexico City, Mexico, 03100
- Recruiting
- CENEIT Oncologicos
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Jalisco
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Guadalajara, Jalisco, Mexico, 44280
- Active, not recruiting
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Mexico CITY (federal District)
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Mexico City, Mexico CITY (federal District), Mexico, 06700
- Recruiting
- Centro Oncológico Hematológico Roma
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Mexico City, Mexico CITY (federal District), Mexico, 03100
- Active, not recruiting
- OncoMed
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Withdrawn
- Hospital Universitario
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Muscat, Oman
- Recruiting
- Sultan Qaboos Comprehensive Cancer Care & Research Center
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Bydgoszcz, Poland, 85-796
- Active, not recruiting
- Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
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Gda?sk, Poland, 80-214
- Active, not recruiting
- Uniwersyteckie Centrum Kliniczne
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Gdynia, Poland, 81-519
- Active, not recruiting
- Szpital Morski im.PCK
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Gliwice, Poland, 44-102
- Withdrawn
- Narodowy Instytut Onkologii Odzia? w Gliwicach
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Konin, Poland, 62-500
- Recruiting
- Przychodnia Lekarska KOMED, Roman Karaszewski
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Koszalin, Poland, 75-581
- Active, not recruiting
- Szpital Wojewódzki im. Miko?aja Kopernika
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Późna, Poland, 61-866
- Recruiting
- Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
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Warsaw, Poland, 02-781
- Active, not recruiting
- Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
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Singapore, Singapore, 119228
- Recruiting
- National University Hospital
-
Singapore, Singapore, 169610
- Completed
- National Cancer Centre
-
Singapore, Singapore, 308433
- Withdrawn
- Tan Tock Seng Hospital
-
Singapore, Singapore, 217562
- Withdrawn
- Icon Cancer Centre Farrer Park
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-
-
-
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Hilton, South Africa, 3245
- Recruiting
- Hopelands Cancer Centre
-
Johannesburg, South Africa, 2193
- Recruiting
- Charlotte Maxeke Academic Hospital
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Johannesburg, South Africa, 2196
- Active, not recruiting
- Medical Oncology Centre of Rosebank
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Polokwane, South Africa, 0700
- Active, not recruiting
- Limpopo Cancer Research Institute
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Pretoria, South Africa, 0002
- Recruiting
- Steve Biko Academic Hospital
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Soweto, South Africa, 2013
- Active, not recruiting
- Chris Hani Baragwanath Clinical Trial Site
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-
-
-
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Goyang-si, South Korea, 10408
- Active, not recruiting
- National Cancer Center
-
Seoul, South Korea, 03080
- Active, not recruiting
- Seoul National University Hospital
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Seoul, South Korea, 06351
- Active, not recruiting
- Samsung Medical Center
-
Seoul, South Korea, 06591
- Active, not recruiting
- Seoul St Mary's Hospital
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Seoul, South Korea, 03722
- Active, not recruiting
- Severance Hospital, Yonsei University Health System
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Seoul, South Korea, 05505
- Completed
- Asan Medical Center
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Seoul, South Korea, 06273
- Active, not recruiting
- Gangnam Severance Hospital
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-
-
-
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall d'Hebron
-
Barcelona, Spain, 08028
- Recruiting
- Hospital Universitari Dexeus - Grupo Quironsalud
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Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain, 28034
- Recruiting
- Hospital Ramon y Cajal
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Madrid, Spain, 28041
- Active, not recruiting
- Hospital Universitario 12 de Octubre
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Málaga, Spain, 29010
- Recruiting
- Hospital Clinico Universitario Virgen de la Victoria
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Seville, Spain, 41009
- Recruiting
- Hospital Universitario Virgen Macarena
-
-
LA Coruna
-
A Coruña, LA Coruna, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruña (CHUAC)
-
-
-
-
-
Taipei, Taiwan
- Recruiting
- Tri-Service General Hospital
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan Uni Hospital
-
Taoyuan County, Taiwan, 333
- Recruiting
- Chang Gung Memorial Hospital-Linkou
-
-
-
-
-
Aryanah, Tunisia, 2080
- Recruiting
- Abderrahmen Mami Hospital
-
Nabeul, Tunisia, 8000
- Recruiting
- Taher Maamouri Hospital
-
Sfax, Tunisia, 3029
- Recruiting
- Habib Bourguiba Hospital
-
Sousse, Tunisia, 4031
- Recruiting
- Farhat Hached Hospital
-
Tunis, Tunisia, 1006
- Recruiting
- Institut Salah Azeiz
-
-
-
-
-
Adapazarı, Turkey (Türkiye), 54290
- Active, not recruiting
- Sakarya Training and Research Hospital
-
Ankara, Turkey (Türkiye), 06010
- Recruiting
- Gulhane Training and Research Hospital
-
Ankara, Turkey (Türkiye), 06500
- Recruiting
- Gazi University Medical Faculty
-
Bakirkoy / Istanbul, Turkey (Türkiye), 34147
- Recruiting
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
-
Diyarbakır, Turkey (Türkiye), 21280
- Recruiting
- Dicle University Faculty of Medicine
-
Istanbul, Turkey (Türkiye), 34214
- Active, not recruiting
- Medipol Mega Üniversite Hastanesi Göztepe
-
Izmir, Turkey (Türkiye), 35360
- Active, not recruiting
- Izmir Ataturk Training and Research Hospital
-
Seyhan, Turkey (Türkiye), 01140
- Active, not recruiting
- Medical Park Seyhan Hospital
-
Sihhiye/Ankara, Turkey (Türkiye), 06230
- Recruiting
- Hacettepe Uni Medical Faculty Hospital
-
-
-
-
-
Kampala, Uganda, 00256
- Recruiting
- Uganda Cancer Institute
-
-
-
-
-
Belfast, United Kingdom, BT9 7AB
- Withdrawn
- Belfast City Hospital
-
Blackpool, United Kingdom, FY3 8NR
- Recruiting
- Blackpool Victoria Hospital
-
Colchester, Essex, United Kingdom, CO4 5JL
- Recruiting
- Colchester General Hospital
-
Northwood, United Kingdom, HA6 2RN
- Recruiting
- Mount Vernon Hospital
-
Nottingham, United Kingdom, NG5 1PB
- Recruiting
- Nottingham City Hospital
-
Oxford, United Kingdom, OX3 7LJ
- Recruiting
- Churchill Hospital
-
-
-
-
Arizona
-
Gilbert, Arizona, United States, 85234
- Recruiting
- Banner Health MD Anderson AZ
-
-
California
-
Burbank, California, United States, 91505
- Recruiting
- Disney Family Cancer Center
-
Corona, California, United States, 92882
- Recruiting
- City of Hope
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Comprehensive Cancer Center
-
Irvine, California, United States, 92618
- Recruiting
- City of Hope at Irvine Lennar
-
Los Angeles, California, United States, 90064
- Recruiting
- Ellison Institute of Technology
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20007
- Recruiting
- Georgetown Uni Hospital
-
-
Maryland
-
Hyattsville, Maryland, United States, 20783
- Recruiting
- Medstar Research Institute
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana Farber Cancer Institute
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
-
-
Nevada
-
Reno, Nevada, United States, 89502
- Withdrawn
- Renown Regional Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Active, not recruiting
- Hackensack University Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28209
- Recruiting
- Atrium Health
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73102
- Withdrawn
- Hightower Clinical
-
-
Texas
-
El Paso, Texas, United States, 79915
- Recruiting
- Renovatio Clinical - El Paso
-
Fort Worth, Texas, United States, 76104
- Recruiting
- JPS Health Network
-
Kingwood, Texas, United States, 77339
- Withdrawn
- Lumi Research
-
The Woodlands, Texas, United States, 77380
- Recruiting
- Renovatio Clinical
-
-
Washington
-
Kennewick, Washington, United States, 99336-7774
- Recruiting
- Kadlec Clinic Hematology and Oncology
-
Seattle, Washington, United States, 98104-1360
- Recruiting
- Swedish Medical Center
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
3
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Participants will be administered the treatments as outlined in the interventions section.
|
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Other Names:
|
|
Experimental: Maintenance Therapy: Inavolisib plus Phesgo
Participants will be administered the treatments as outlined in the interventions section.
|
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
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.
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.
Other Names:
|
|
Active Comparator: Maintenance Therapy: Placebo plus Phesgo
Participants will be administered the treatments as outlined in the interventions section.
|
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
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.
Other Names:
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Investigator-Assessed Progression-Free Survival (PFS)
Time Frame: Up to approximately 40 months
|
Up to approximately 40 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Up to approximately 111 months
|
Up to approximately 111 months
|
|
|
Investigator-Assessed Objective Response Rate (ORR)
Time Frame: Up to approximately 111 months
|
Up to approximately 111 months
|
|
|
Investigator-Assessed Duration of Response (DOR)
Time Frame: Up to approximately 111 months
|
Up to approximately 111 months
|
|
|
Investigator-Assessed Clinical Benefit Rate (CBR)
Time Frame: Up to approximately 111 months
|
Up to approximately 111 months
|
|
|
Investigator-Assessed PFS2
Time Frame: Up to approximately 111 months
|
Up to approximately 111 months
|
|
|
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)
Time Frame: 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)
|
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.
|
|
Percentage of Participants with Adverse Events
Time Frame: Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days.
|
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
Time Frame: Day 1 of Cycles 1 and 4. Each cycle is 21 days.
|
Day 1 of Cycles 1 and 4. Each cycle is 21 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
September 8, 2023
Primary Completion (Estimated)
Primary Completion
December 31, 2026
Study Completion (Estimated)
Study Completion
December 28, 2032
Study Registration Dates
First Submitted
First Submitted
May 24, 2023
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
June 7, 2023
First Posted (Actual)
First Posted
June 8, 2023
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
May 29, 2026
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
May 27, 2026
Last Verified
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- WO44263
- 2022-502046-28-00 (Registry Identifier: EU Clinical Trials)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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