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
2 other identifiers
interventional
230
28 countries
187
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2023
Longer than P75 for phase_3
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedStudy Start
First participant enrolled
September 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 28, 2032
May 29, 2026
May 1, 2026
3.3 years
May 24, 2023
May 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Investigator-Assessed Progression-Free Survival (PFS)
Up to approximately 40 months
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (3)
Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
OTHERParticipants will be administered the treatments as outlined in the interventions section.
Maintenance Therapy: Inavolisib plus Phesgo
EXPERIMENTALParticipants will be administered the treatments as outlined in the interventions section.
Maintenance Therapy: Placebo plus Phesgo
ACTIVE COMPARATORParticipants will be administered the treatments as outlined in the interventions section.
Interventions
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.
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (192)
Banner Health MD Anderson AZ
Gilbert, Arizona, 85234, United States
Disney Family Cancer Center
Burbank, California, 91505, United States
City of Hope
Corona, California, 92882, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
Ellison Institute of Technology
Los Angeles, California, 90064, United States
Georgetown Uni Hospital
Washington D.C., District of Columbia, 20007, United States
Medstar Research Institute
Hyattsville, Maryland, 20783, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Atrium Health
Charlotte, North Carolina, 28209, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
Renovatio Clinical - El Paso
El Paso, Texas, 79915, United States
JPS Health Network
Fort Worth, Texas, 76104, United States
Lumi Research
Kingwood, Texas, 77339, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336-7774, United States
Swedish Medical Center
Seattle, Washington, 98104-1360, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE, Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
Hospital Provincial del Centenario
Rosario, S2002KDS, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, J5400DIL, Argentina
Clínica Viedma
Viedma Rio Negro, R8500ACE, Argentina
Blacktown Hospital
Blacktown, New South Wales, NSW 2148, Australia
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010, Australia
Gosford Hospital
Gosford, New South Wales, 2250, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
Institut Jules Bordet
Anderlecht, 1070, Belgium
CHIREC
Auderghem, 1160, Belgium
CHU Brugmann (Victor Horta)
Brussels, 1020, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
GHdC Site Les Viviers
Charleroi, 6000, Belgium
CHU HELORA - Hôpital de la Louvière - Site Jolimont
Haine-Saint-Paul, 7100, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-232, Brazil
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070, Brazil
Hospital do Câncer de Londrina
Londrina, Paraná, 86015-520, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital de Amor Amazônia
Porto Velho, Rondônia, 76834-899, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-001, Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, T2N 5G2, Canada
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Eastern Health - General Hospital
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, PO 25223, Canada
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8, Canada
Allan Blair Cancer Center
Regina, Saskatchewan, S4T 7T1, Canada
Affiliated Hospital of Hebei University
Baoding, 071000, China
Beijing Cancer Hospital
Beijing, 100142, China
The First Hospital of Jilin University
Changchun, 130021, China
Sichuan Provincial Cancer Hospital
Chengdu, 610041, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Tumor Hospital
Harbin, 150049, China
Shandong Cancer Hospital
Jinan, 250117, China
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang, 471003, China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
Shantou Center Hospital
Shantou, 515031, China
Tianjin Cancer Hospital
Tianjin, 300000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Hubei Cancer Hospital
Wuhan, 430079, China
Clinica De La Costa
Barranquilla, 080020, Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., 110131, Colombia
Oncomedica S.A.
Montería, 230002, Colombia
Sociedad de Oncología y hematología del Cesar Ltda
Valledupar, 200001, Colombia
Tampere University Hospital
Tampere, 33520, Finland
Turku Uni Central Hospital
Turku, 20520, Finland
Institut Sainte Catherine
Avignon, 84082, France
Centre Hospitalier de La Cote Basque
Bayonne, 64109, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
Centre Georges Francois Leclerc
Dijon, 21000, France
Centre Oscar Lambret
Lille, 59020, France
Klinikum St. Marien
Amberg, 92224, Germany
HELIOS Klinikum Berlin-Buch
Berlin, 13125, Germany
Marienhospital Bottrop gGmbH
Bottrop, 46236, Germany
Gynonco Düsseldorf, MVZ Medical Center GmbH
Düsseldorf, 40235, Germany
Frauenarztpraxis Dr. Apel, Dr. Kolpin
Erfurt, 99084, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, 80336, Germany
St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren
Münster, 48145, Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, 66113, Germany
Gynäkologie Kompetenzzentrum
Stralsund, 18439, Germany
Universitätsfrauenklinik Ulm
Ulm, 89075, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Gujarat Cancer & Research Inst.
Ahmedabad, Gujarat, 380016, India
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
Surat, Gujarat, 395007, India
Artemis Hospital
Gurugram, Haryana, 122001, India
Sir H. N. Reliance Foundation Hospital and Research Centre
Mumbai, Maharashtra, 400004, India
National Cancer Institute
Nagpur, Maharashtra, 441108, India
Max Super Speciality Hospital
NEW Delhi Delhi, National Capital Territory of Delhi, 110092, India
Tata Medical Center
Kolkata, West Bengal, 700160, India
I.R.S.T Srl IRCCS
Meldola, Emilia-Romagna, 47014, Italy
Ospedale San Giovanni Addolorata
Rome, Lazio, 00185, Italy
Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, 20141, Italy
Ospedale San Gerardo
Monza, Lombardy, 20900, Italy
A.O.U. Maggiore della Carità
Novara, Piedmont, 28100, Italy
Casa di Cura La Maddalena
Palermo, Sicily, 90146, Italy
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Tuscany, 50012, Italy
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
Verona, Veneto, 37124, Italy
Nagoya City University Hospital
Aichi, 467-8602, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
Sagara Hospital
Kagoshima, 892-0833, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Saitama Medical University International Medical Center
Saitama, 350-1298, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
King Hussein Cancer Center
Amman, 11941, Jordan
University of Nairobi - Institute of Tropical and Infectious Diseases
Nairobi, Kenya
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
OncoMed
Mexico City, Mexico CITY (federal District), 03100, Mexico
Centro Oncológico Hematológico Roma
Mexico City, Mexico CITY (federal District), 06700, Mexico
Hospital Universitario
Monterrey, Nuevo León, 64460, Mexico
CENEIT Oncologicos
Mexico City, 03100, Mexico
Sultan Qaboos Comprehensive Cancer Care & Research Center
Muscat, Oman
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, 85-796, Poland
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214, Poland
Szpital Morski im.PCK
Gdynia, 81-519, Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, 44-102, Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, 62-500, Poland
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, 75-581, Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Późna, 61-866, Poland
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
Warsaw, 02-781, Poland
National University Hospital
Singapore, 119228, Singapore
National Cancer Centre
Singapore, 169610, Singapore
Icon Cancer Centre Farrer Park
Singapore, 217562, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Hopelands Cancer Centre
Hilton, 3245, South Africa
Charlotte Maxeke Academic Hospital
Johannesburg, 2193, South Africa
Medical Oncology Centre of Rosebank
Johannesburg, 2196, South Africa
Limpopo Cancer Research Institute
Polokwane, 0700, South Africa
Steve Biko Academic Hospital
Pretoria, 0002, South Africa
Chris Hani Baragwanath Clinical Trial Site
Soweto, 2013, South Africa
National Cancer Center
Goyang-si, 10408, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St Mary's Hospital
Seoul, 06591, South Korea
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, 15006, Spain
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, 08028, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
National Taiwan Uni Hospital
Taipei, 100, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital-Linkou
Taoyuan County, 333, Taiwan
Abderrahmen Mami Hospital
Aryanah, 2080, Tunisia
Taher Maamouri Hospital
Nabeul, 8000, Tunisia
Habib Bourguiba Hospital
Sfax, 3029, Tunisia
Farhat Hached Hospital
Sousse, 4031, Tunisia
Institut Salah Azeiz
Tunis, 1006, Tunisia
Sakarya Training and Research Hospital
Adapazarı, 54290, Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147, Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, 21280, Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, 34214, Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, 35360, Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, 01140, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, 06230, Turkey (Türkiye)
Uganda Cancer Institute
Kampala, 00256, Uganda
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
Colchester General Hospital
Colchester, Essex, CO4 5JL, United Kingdom
Mount Vernon Hospital
Northwood, HA6 2RN, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: WO44263 https://forpatients.roche.com/
CONTACT
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2023
First Posted
June 8, 2023
Study Start
September 8, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 28, 2032
Last Updated
May 29, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
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