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)

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: Recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Phesgo; Drug: Taxane-based Chemotherapy; Drug: Inavolisib; Drug: Optional Endocrine Therapy of Investigator's Choice; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 3

Contacts and Locations

• 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 Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
    • Recruiting
    • Centro Oncologico Korben
  • Rosario, Argentina, S2000KZE
    • Recruiting
    • Instituto de Oncologia de Rosario
  • Rosario, Argentina, S2002KDS
    • Recruiting
    • Hospital Provincial del Centenario
  • San Juan, Argentina, J5400DIL
    • Recruiting
    • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
  • Viedma Rio Negro, Argentina, R8500ACE
    • Withdrawn
    • Clinica Viedma
  • Ciudad Autónoma de BuenosAires
    • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1113AAE
      • Active, not recruiting
      • Centro de Investigaciones Médicas y Desarrollo LC S.R.L
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Active, not recruiting
      • Blacktown Hospital
    • Darlinghurst, New South Wales, Australia, 2010
      • Active, not recruiting
      • Kinghorn Cancer Centre
    • Gosford, New South Wales, Australia, 2250
      • Active, not recruiting
      • Gosford Hospital
  • Queensland
    • Sippy Downs, Queensland, Australia, 4556
      • Active, not recruiting
      • University of the Sunshine Coast
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Completed
      • Monash Health
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Completed
      • Sir Charles Gairdner Hospital
• Belgium
  • Anderlecht, Belgium, 1070
    • Withdrawn
    • Institut Jules Bordet
  • Auderghem, Belgium, 1160
    • Withdrawn
    • CHIREC
  • Brussels, Belgium, 1200
    • Withdrawn
    • Cliniques Universitaires St-Luc
  • Brussels, Belgium, 1020
    • Withdrawn
    • CHU Brugmann (Victor Horta)
  • Charleroi, Belgium, 6000
    • Withdrawn
    • GHdC Site Les Viviers
  • Haine-Saint-Paul, Belgium, 7100
    • Recruiting
    • CHU HELORA - Hôpital de La Louvière - site Jolimont
  • Hasselt, Belgium, 3500
    • Withdrawn
    • Jessa Zkh (Campus Virga Jesse)
  • Namur, Belgium, 5000
    • Withdrawn
    • Clinique Ste-Elisabeth
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60336-232
      • Recruiting
      • Crio - Centro Regional Integrado de Oncologia
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-190
      • Recruiting
      • Hospital Sao Rafael - HSR
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-070
      • Recruiting
      • Hospital Araujo Jorge
  • Paraná
    • Londrina, Paraná, Brazil, 86015-520
      • Recruiting
      • Hospital do Cancer de Londrina
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50040-000
      • Recruiting
      • Hospital do Cancer de Pernambuco - HCP
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Active, not recruiting
      • Santa Casa de Misericordia de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Recruiting
      • Hospital Sao Lucas - PUCRS
  • Rondônia
    • Porto Velho, Rondônia, Brazil, 76834-899
      • Recruiting
      • Hospital de Amor Amazônia
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Recruiting
      • Hospital de Cancer de Barretos
    • 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
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Recruiting
      • Arthur J.E. Child Comprehensive Cancer Center-Calgary
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Recruiting
      • The Moncton Hospital
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Recruiting
      • Eastern Health - General Hospital
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H4J 1C5
      • Recruiting
      • Hôpital du Sacré-Coeur de Montréal
    • Montreal, Quebec, Canada, PO 25223
      • Recruiting
      • Centre Hospitalier de l?Université de Montréal (CHUM)
    • Québec, Quebec, Canada, G1S 4L8
      • Recruiting
      • Hopital du Saint Sacrement
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Recruiting
      • Allan Blair Cancer Center
• China
  • 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
  • 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
• Colombia
  • 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
  • Montería, Colombia, 230002
    • Recruiting
    • Oncomedica S.A.
  • Valledupar, Colombia, 200001
    • Recruiting
    • Sociedad de Oncología y hematología del Cesar Ltda
• Finland
  • Tampere, Finland, 33520
    • Active, not recruiting
    • Tampere University Hospital
  • Turku, Finland, 20520
    • Active, not recruiting
    • Turku Uni Central Hospital
• France
  • Avignon, France, 84082
    • Recruiting
    • Institut Sainte Catherine
  • Bayonne, France, 64109
    • Recruiting
    • Centre Hospitalier de la Côte Basque
  • Bordeaux, France, 33300
    • Recruiting
    • Polyclinique Bordeaux Nord Aquitaine
  • Dijon, France, 21000
    • Recruiting
    • Centre Georges Francois Leclerc
  • Lille, France, 59020
    • Recruiting
    • Centre Oscar Lambret
• Germany
  • Amberg, Germany, 92224
    • Recruiting
    • Klinikum St. Marien
  • Berlin, Germany, 13125
    • Recruiting
    • Helios Klinikum Berlin-Buch
  • Bottrop, Germany, 46236
    • Recruiting
    • Marienhospital Bottrop gGmbH
  • Düsseldorf, Germany, 40235
    • Withdrawn
    • Gynonco Düsseldorf, MVZ Medical Center GmbH
  • Erfurt, Germany, 99084
    • Recruiting
    • Frauenarztpraxis Dr. Apel, Dr. Kolpin
  • Erlangen, Germany, 91054
    • Recruiting
    • Universitatsklinikum Erlangen
  • Freiburg im Breisgau, Germany, 79110
    • Recruiting
    • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  • München, Germany, 80336
    • Recruiting
    • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
  • Münster, Germany, 48145
    • Recruiting
    • St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren
  • Saarbrücken, Germany, 66113
    • Recruiting
    • Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
  • Stralsund, Germany, 18439
    • Withdrawn
    • Gynäkologie Kompetenzzentrum
  • Ulm, Germany, 89075
    • Recruiting
    • Universitätsfrauenklinik Ulm
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Recruiting
    • Tuen Mun Hospital
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380016
      • Recruiting
      • Gujarat Cancer & Research Inst.
    • Surat, Gujarat, India, 395007
      • Recruiting
      • Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
  • Haryana
    • Gurugram, Haryana, India, 122001
      • Recruiting
      • Artemis hospital
  • Maharashtra
    • Mumbai, Maharashtra, India, 400004
      • Recruiting
      • Sir H. N. Reliance Foundation Hospital and Research Centre
    • Nagpur, Maharashtra, India, 441108
      • Recruiting
      • National Cancer Institute
  • National Capital Territory of Delhi
    • NEW Delhi Delhi, National Capital Territory of Delhi, India, 110092
      • Recruiting
      • Max Super Speciality Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700160
      • Recruiting
      • Tata Medical Center
• Italy
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • Recruiting
      • I.R.S.T Srl IRCCS
  • Lazio
    • Rome, Lazio, Italy, 00185
      • Recruiting
      • Ospedale San Giovanni Addolorata
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Ospedale San Raffaele
    • Milan, Lombardy, Italy, 20141
      • Recruiting
      • Irccs Istituto Europeo di Oncologia (IEO)
    • Milan, Lombardy, Italy, 20133
      • Recruiting
      • Irccs Istituto Nazionale Dei Tumori (Int)
    • Monza, Lombardy, Italy, 20900
      • Recruiting
      • Ospedale San Gerardo
  • Piedmont
    • Novara, Piedmont, Italy, 28100
      • Recruiting
      • A.O.U. Maggiore della Carita
  • Sicily
    • Palermo, Sicily, Italy, 90146
      • Recruiting
      • Casa di Cura La Maddalena
  • Tuscany
    • Bagno a Ripoli, Tuscany, Italy, 50012
      • Recruiting
      • Ospedale Santa Maria Annunziata
  • Veneto
    • Verona, Veneto, Italy, 37124
      • Withdrawn
      • "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
• Japan
  • Aichi, Japan, 467-8602
    • Recruiting
    • Nagoya City University Hospital
  • Chiba, Japan, 260-8717
    • Recruiting
    • Chiba Cancer Center
  • Hiroshima, Japan, 730-8518
    • Recruiting
    • Hiroshima City Hiroshima Citizens Hospital
  • Kagoshima, Japan, 892-0833
    • Recruiting
    • Sagara Hospital
  • Kanagawa, Japan, 259-1193
    • Recruiting
    • Tokai University Hospital
  • Kyoto, Japan, 606-8507
    • Recruiting
    • Kyoto University Hospital
  • Matsuyama, Japan, 791-0280
    • Recruiting
    • National Hospital Organization Shikoku Cancer Center
  • Saitama, Japan, 350-1298
    • Recruiting
    • Saitama Medical University International Medical Center
  • Tokyo, Japan, 135-8550
    • Recruiting
    • The Cancer Institute Hospital of JFCR
• Jordan
  • Amman, Jordan, 11941
    • Recruiting
    • King Hussein Cancer Center
• Kenya
  • Nairobi, Kenya
    • Recruiting
    • University of Nairobi - Institute of Tropical and Infectious Diseases
• Mexico
  • Mexico City, Mexico, 03100
    • Recruiting
    • CENEIT Oncologicos
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Recruiting
      • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 06700
      • Recruiting
      • Centro Oncológico Hematológico Roma
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Recruiting
      • Oncomed
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Withdrawn
      • Hospital Universitário
• Oman
  • Muscat, Oman
    • Recruiting
    • Sultan Qaboos Comprehensive Cancer Care & Research Center
• Poland
  • Bydgoszcz, Poland, 85-796
    • Recruiting
    • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
  • Gda?sk, Poland, 80-214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Gdynia, Poland, 81-519
    • Recruiting
    • Szpital Morski im.PCK
  • Gliwice, Poland, 44-102
    • Withdrawn
    • Narodowy Instytut Onkologii Odzia? w Gliwicach
  • Konin, Poland, 62-500
    • Recruiting
    • Przychodnia Lekarska KOMED, Roman Karaszewski
  • Koszalin, Poland, 75-581
    • Recruiting
    • Szpital Wojewódzki im. Miko?aja Kopernika
  • Późna, Poland, 61-866
    • Recruiting
    • Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
  • Warsaw, Poland, 02-781
    • Recruiting
    • Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
• Singapore
  • 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
• South Africa
  • Hilton, South Africa, 3245
    • Recruiting
    • Hopelands Cancer Centre
  • Johannesburg, South Africa, 2193
    • Recruiting
    • Charlotte Maxeke Academic Hospital
  • Johannesburg, South Africa, 2196
    • Recruiting
    • Medical Oncology Centre of Rosebank
  • Polokwane, South Africa, 0700
    • Recruiting
    • Limpopo Cancer Research Institute
  • Pretoria, South Africa, 0002
    • Recruiting
    • Steve Biko Academic Hospital
  • Soweto, South Africa, 2013
    • Active, not recruiting
    • Chris Hani Baragwanath Clinical Trial Site
• South Korea
  • Goyang-si, South Korea, 10408
    • Active, not recruiting
    • National Cancer Center
  • Seoul, South Korea, 03080
    • Active, not recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Active, not recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • Active, not recruiting
    • Seoul St Mary's Hospital
  • Seoul, South Korea, 03722
    • Active, not recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 05505
    • Completed
    • Asan Medical Center
  • Seoul, South Korea, 06273
    • Active, not recruiting
    • Gangnam Severance Hospital
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08028
    • Recruiting
    • Hospital Universitari Dexeus - Grupo Quironsalud
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Ramon Y Cajal
  • Madrid, Spain, 28041
    • Active, not recruiting
    • Hospital Universitario 12 de Octubre
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Clinico Universitario Virgen de la Victoria
  • Seville, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
  • LA Coruna
    • A Coruña, LA Coruna, Spain, 15006
      • Recruiting
      • Complejo Hospitalario Universitario A Coruña (CHUAC)
• Taiwan
  • 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
• Tunisia
  • 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
• Turkey (Türkiye)
  • 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
• Uganda
  • Kampala, Uganda, 00256
    • Recruiting
    • Uganda Cancer Institute
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Recruiting
    • 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
• United States
  • 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
      • Recruiting
      • Renown Regional Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • 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

Participation 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

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 / Arm	Intervention / Treatment
Other: Induction Therapy: Phesgo plus Taxane-Based Chemotherapy; Participants will be administered the treatments as outlined in the interventions section.	Drug: Phesgo; Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.; Drug: Taxane-based Chemotherapy; During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.; Other Names: non-investigational medicinal product (NIMP)
Experimental: Maintenance Therapy: Inavolisib plus Phesgo; Participants will be administered the treatments as outlined in the interventions section.	Drug: Phesgo; Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.; Drug: 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.; Drug: 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.; Other Names: NIMP
Active Comparator: Maintenance Therapy: Placebo plus Phesgo; Participants will be administered the treatments as outlined in the interventions section.	Drug: Phesgo; Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.; Drug: 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.; Other Names: NIMP; Drug: Placebo; 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

Outcome Measure	Time Frame
Investigator-Assessed Progression-Free Survival (PFS)	Up to approximately 40 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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		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.

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 28, 2032

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Substandard Drugs; Pharmaceutical Preparations; inavolisib
• 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