A clinical trial to compare RO7198574 plus inavolisib with RO7198574 plus placebo as maintenance treatment after first treatment in people with PIK3CA‑mutated HER2‑positive breast cancer that has grown (locally advanced) or spread (metastatic)

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

  • Cancer
  • Breast Cancer
  • Breast Cancer Er‑Positive
  • Metastatic Breast Cancer
  • HER2-Positive Breast Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Cities
  • A Coruña
  • ABD
  • Adana
  • adelphi
  • Amberg
  • Amman
  • Ankara
  • Avignon
  • Bahia
  • bao-ding-shi
  • Barcelona
  • Barranquilla
  • Bayonne
  • bei-jing-shi
  • Blackpool
  • Blacktown
  • Bogotá
  • Bordeaux
  • Boston
  • bottrop
  • Bruxelles
  • Buenos Aires
  • Burbank
  • Bydgoszcz
  • Ceará
  • chang-chun-shi
  • Charleroi
  • Charlotte
  • Cheng Du Shi
  • Chengdu
  • Chihuahua
  • Ciudad de México
  • Clayton
  • Colchester
  • Darlinghurst
  • Delhi
  • Detroit
  • dil
  • Diyarbakır
  • Düsseldorf
  • Erfurt
  • Freiburg im Breisgau
  • Fuzhou
  • Gdańsk
  • Gdynia
  • Gilbert
  • Gliwice
  • Goiás
  • Gosford
  • Goyang-si
  • grassina
  • Guadalajara
  • Gurugram
  • Hackensack
  • hang-zhou-shi
  • Harbin
  • Hasselt
  • Hilton
  • Hong Kong Island
  • Houston
  • İstanbul
  • İzmir
  • Jinan
  • Johannesburg
  • Kennewick
  • Kolkata
  • Konin
  • Koszalin
  • Lombardia
  • Los Angeles
  • Luo Yang Shi
  • Madrid
  • Meldola
  • Milano
  • Moncton
  • Monterrey
  • Montería
  • Montréal
  • Monza
  • Málaga
  • München
  • Namur
  • nan-ning-shi
  • Nanchang
  • Nedlands
  • New Territories
  • Northwood
  • Nottingham
  • Novara
  • Oklahoma City
  • Oxford
  • Palermo
  • Paraná
  • Pernambuco
  • Polokwane
  • Poznań
  • Pretoria
  • Québec
  • Regina
  • Reno
  • Rio Grande do Sul
  • Roma
  • rondonia
  • Rosario
  • Saarbrücken
  • Santa Fe
  • Seattle
  • Seoul
  • Sevilla
  • shan-tou-shi
  • Singapore
  • Sippy Downs
  • Soweto
  • Stralsund
  • São Paulo
  • Taipei City
  • Tampere
  • Taoyuan City
  • tian-jin-shi
  • Toronto
  • Turku
  • Vadodara
  • Verona
  • Viedma
  • Warszawa
  • Washington
  • wu-han-shi
Trial Identifier:

NCT05894239 2022-502046-28-00 WO44263

  • Hopelands Cancer Centre

    Recruiting

    3245HiltonSouth Africa
  • Charlotte Maxeke Academic Hospital

    Recruiting

    2193JohannesburgSouth Africa
  • Medical Oncology Centre of Rosebank

    Recruiting

    2196JohannesburgSouth Africa
  • Limpopo Cancer Research Institute

    Recruiting

    0700PolokwaneSouth Africa
  • Steve Biko Academic Hospital

    Recruiting

    0002PretoriaSouth Africa
  • Banner Health MD Anderson AZ

    Recruiting

    85234GilbertUnited States
  • Disney Family Cancer Center

    Recruiting

    91505BurbankUnited States
  • Ellison Institute of Technology

    Recruiting

    90064Los AngelesUnited States
  • Georgetown Uni Hospital

    Recruiting

    20007WashingtonUnited States
  • Medstar Research Institute

    Recruiting

    20783adelphiUnited States
  • Dana Farber Cancer Institute

    Recruiting

    02215BostonUnited States
  • Henry Ford Hospital

    Recruiting

    48202DetroitUnited States
  • Renown Regional Medical Center

    Recruiting

    89502RenoUnited States
  • Hackensack University Medical Center

    Recruiting

    07601HackensackUnited States
  • Atrium Health

    Recruiting

    28209CharlotteUnited States
  • Hightower Clinical

    Recruiting

    73102Oklahoma CityUnited States
  • Kadlec Clinic Hematology and Oncology

    Recruiting

    99336KennewickUnited States
  • Swedish Medical Center

    Recruiting

    98104-1360SeattleUnited States
  • Centro Oncologico Korben

    Recruiting

    C1426Buenos AiresArgentina
  • Instituto de Oncología de Rosario

    Recruiting

    S2000RosarioArgentina
  • Hospital Provincial del Centenario

    Recruiting

    S2002Santa FeArgentina
  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

    Recruiting

    J5402dilArgentina
  • Clínica Viedma

    Recruiting

    R8500ViedmaArgentina
  • Blacktown Hospital

    Recruiting

    2148BlacktownAustralia
  • Kinghorn Cancer Centre

    Recruiting

    2010DarlinghurstAustralia
  • Gosford Hospital

    Recruiting

    2250GosfordAustralia
  • University of the Sunshine Coast

    Recruiting

    4556Sippy DownsAustralia
  • Monash Health

    Recruiting

    3168ClaytonAustralia
  • Sir Charles Gairdner Hospital

    Recruiting

    6009NedlandsAustralia
  • Cliniques Universitaires St-Luc

    Recruiting

    1200BruxellesBelgium
  • GHdC Site Notre Dame

    Recruiting

    6000CharleroiBelgium
  • Jessa Zkh (Campus Virga Jesse)

    Recruiting

    3500HasseltBelgium
  • Clinique Ste-Elisabeth

    Recruiting

    5000NamurBelgium
  • Hospital Sao Rafael - HSR

    Recruiting

    41253-190BahiaBrazil
  • Crio - Centro Regional Integrado de Oncologia

    Recruiting

    60335-480CearáBrazil
  • Hospital Araujo Jorge

    Recruiting

    74605-070GoiásBrazil
  • Hospital do Câncer de Londrina

    Recruiting

    86015-520ParanáBrazil
  • Hospital do Cancer de Pernambuco - HCP

    Recruiting

    50040-000PernambucoBrazil
  • Hospital Sao Lucas - PUCRS

    Recruiting

    90610-001Rio Grande do SulBrazil
  • Hospital de Amor Amazônia

    Recruiting

    76834-899rondoniaBrazil
  • Hospital de Cancer de Barretos

    Recruiting

    14784-400São PauloBrazil
  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    Recruiting

    01246-000São PauloBrazil
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    Recruiting

    01317-001São PauloBrazil
  • Arthur J.E. Child Comprehensive Cancer Center-Calgary

    Recruiting

    T2N 5G2
  • The Moncton Hospital

    Recruiting

    E1C 4B7MonctonCanada
  • Eastern Health - General Hospital

    Recruiting

    A1B 3X5
  • Sunnybrook Health Sciences Centre

    Recruiting

    M4N 3M5TorontoCanada
  • Centre Hospitalier de l?Université de Montréal (CHUM)

    Recruiting

    H2X 3E4MontréalCanada
  • Jewish General Hospital

    Recruiting

    H3T 1E2MontréalCanada
  • Hôpital du Sacré-Coeur de Montreal

    Recruiting

    H4J 1C5MontréalCanada
  • Hopital du Saint Sacrement

    Recruiting

    G1S 4L8QuébecCanada
  • Allan Blair Cancer Center

    Recruiting

    S4T 7T1ReginaCanada
  • Affiliated Hospital of Hebei University

    Recruiting

    071051bao-ding-shiChina
  • Beijing Cancer Hospital

    Recruiting

    100142bei-jing-shiChina
  • The First Hospital of Jilin University

    Recruiting

    130021chang-chun-shiChina
  • Sichuan Provincial Cancer Hospital

    Recruiting

    610041ChengduChina
  • Sichuan Provincial People's Hospital

    Recruiting

    610032Cheng Du ShiChina
  • Fujian Cancer Hospital

    Recruiting

    350014FuzhouChina
  • Zhejiang Cancer Hospital

    Recruiting

    310022hang-zhou-shiChina
  • Harbin Medical University Tumor Hospital

    Recruiting

    150049HarbinChina
  • Shandong Cancer Hospital

    Recruiting

    250117JinanChina
  • The First Affiliated Hospital to Henan University of Science and Technology

    Recruiting

    471000Luo Yang ShiChina
  • The Second Affiliated Hospital to Nanchang University

    Recruiting

    330047NanchangChina
  • Guangxi Cancer Hospital of Guangxi Medical University

    Recruiting

    530021nan-ning-shiChina
  • Shantou Center Hospital

    Recruiting

    515031shan-tou-shiChina
  • Tianjin Cancer Hospital

    Recruiting

    300060tian-jin-shiChina
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Recruiting

    430014wu-han-shiChina
  • Hubei Cancer Hospital

    Recruiting

    430079wu-han-shiChina
  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

    Recruiting

    110131BogotáColombia
  • Oncomedica S.A.

    Recruiting

    230002MonteríaColombia
  • Tampere University Hospital

    Recruiting

    33520TampereFinland
  • Turku Uni Central Hospital

    Recruiting

    20520TurkuFinland
  • Institut Sainte Catherine

    Recruiting

    84082AvignonFrance
  • Centre Hospitalier de La Cote Basque

    Recruiting

    64100BayonneFrance
  • Polyclinique Bordeaux Nord Aquitaine

    Recruiting

    33300BordeauxFrance
  • Klinikum St. Marien

    Recruiting

    92224AmbergGermany
  • Marienhospital Bottrop gGmbH

    Recruiting

    46236bottropGermany
  • Gynonco Düsseldorf, MVZ Medical Center GmbH

    Recruiting

    40235DüsseldorfGermany
  • Frauenarztpraxis Dr. Apel, Dr. Kolpin

    Recruiting

    99084ErfurtGermany
  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Recruiting

    79110Freiburg im BreisgauGermany
  • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

    Recruiting

    80336MünchenGermany
  • Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

    Recruiting

    66113SaarbrückenGermany
  • Gynäkologie Kompetenzzentrum

    Recruiting

    18439StralsundGermany
  • Queen Mary Hospital

    Recruiting

    Hong Kong IslandHong Kong
  • Tuen Mun Hospital

    Recruiting

    New TerritoriesHong Kong
  • Max Super Speciality Hospital

    Recruiting

    110092DelhiIndia
  • Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)

    Recruiting

    395007VadodaraIndia
  • Artemis Hospital

    Recruiting

    122001GurugramIndia
  • Tata Medical Center

    Recruiting

    700160KolkataIndia
  • I.R.S.T Srl IRCCS

    Recruiting

    47014MeldolaItaly
  • Ospedale San Giovanni Addolorata

    Recruiting

    00184RomaItaly
  • Ospedale San Raffaele

    Recruiting

    20132LombardiaItaly
  • Irccs Istituto Nazionale Dei Tumori (Int)

    Recruiting

    20133MilanoItaly
  • Irccs Istituto Europeo Di Oncologia (IEO)

    Recruiting

    20141LombardiaItaly
  • Ospedale San Gerardo

    Recruiting

    20900MonzaItaly
  • A.O.U. Maggiore della Carità

    Recruiting

    28100NovaraItaly
  • Casa di Cura La Maddalena

    Recruiting

    90100PalermoItaly
  • Ospedale Santa Maria Annunziata

    Recruiting

    50012grassinaItaly
  • "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

    Recruiting

    37126VeronaItaly
  • King Hussein Cancer Center

    Recruiting

    11941AmmanJordan
  • University of Nairobi - Institute of Tropical and Infectious Diseases

    Recruiting

    DUMMY_VALUE
  • Seoul National University Hospital

    Recruiting

    03080SeoulSouth Korea
  • Gangnam Severance Hospital

    Recruiting

    06273SeoulSouth Korea
  • Samsung Medical Center

    Recruiting

    06351SeoulSouth Korea
  • Seoul St Mary's Hospital

    Recruiting

    06591SeoulSouth Korea
  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Recruiting

    44200GuadalajaraMexico
  • OncoMed

    Recruiting

    03100Ciudad de MéxicoMexico
  • Centro Oncológico Hematológico Roma

    Recruiting

    06760ChihuahuaMexico
  • Hospital Universitario

    Recruiting

    64460MonterreyMexico
  • CENEIT Oncologicos

    Recruiting

    03100Ciudad de MéxicoMexico
  • Sultan Qaboos Comprehensive Cancer Care & Research Center

    Recruiting

    DUMMY_VALUE
  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Recruiting

    85-796BydgoszczPoland
  • Uniwersyteckie Centrum Kliniczne

    Recruiting

    80-952GdańskPoland
  • Szpital Morski im.PCK

    Recruiting

    81-519GdyniaPoland
  • Narodowy Instytut Onkologii Odzia? w Gliwicach

    Recruiting

    44-102GliwicePoland
  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Recruiting

    62-500KoninPoland
  • Szpital Wojewódzki im. Miko?aja Kopernika

    Recruiting

    75-581KoszalinPoland
  • Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie

    Recruiting

    61-866PoznańPoland
  • Centrum Onkologii Instytut im.M. Sklodowskiej-Curie

    Recruiting

    00-001WarszawaPoland
  • National University Hospital

    Recruiting

    119074SingaporeSingapore
  • Icon Cancer Centre Farrer Park

    Recruiting

    217562SingaporeSingapore
  • Tan Tock Seng Hospital

    Recruiting

    308433SingaporeSingapore
  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    Recruiting

    15006A CoruñaSpain
  • Hospital Universitari Dexeus - Grupo Quironsalud

    Recruiting

    08028BarcelonaSpain
  • Hospital Universitari Vall d'Hebron

    Recruiting

    08035BarcelonaSpain
  • Hospital General Universitario Gregorio Marañon

    Recruiting

    28007MadridSpain
  • Hospital Ramon y Cajal

    Recruiting

    28034MadridSpain
  • Hospital Clinico Universitario Virgen de la Victoria

    Recruiting

    29010MálagaSpain
  • Hospital Universitario Virgen Macarena

    Recruiting

    41009SevillaSpain
  • National Taiwan Uni Hospital

    Recruiting

    100Taipei CityTaiwan
  • Tri-Service General Hospital

    Recruiting

    114Taipei CityTaiwan
  • Chang Gung Memorial Hospital-Linkou

    Recruiting

    333Taoyuan CityTaiwan
  • Gazi University Medical Faculty

    Recruiting

    06570AnkaraTürkiye
  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

    Recruiting

    34158İstanbulTürkiye
  • Dicle University Faculty of Medicine

    Recruiting

    21280DiyarbakırTürkiye
  • Medipol Mega Üniversite Hastanesi Göztepe

    Recruiting

    34214İstanbulTürkiye
  • Katip Celebi University Ataturk Training and Research Hospital

    Recruiting

    35150İzmirTürkiye
  • Hacettepe Uni Medical Faculty Hospital

    Recruiting

    06230AnkaraTürkiye
  • Blackpool Victoria Hospital

    Recruiting

    FY3 8NRBlackpoolUnited Kingdom
  • Colchester General Hospital

    Recruiting

    CO4 5JLColchesterUnited Kingdom
  • Mount Vernon Hospital

    Recruiting

    HA6 2RNNorthwoodUnited Kingdom
  • Nottingham City Hospital

    Recruiting

    NG5 1PBNottinghamUnited Kingdom
  • Churchill Hospital

    Recruiting

    OX3 7LEOxfordUnited Kingdom
  • Chris Hani Baragwanath Clinical Trial Site

    Active, not recruiting

    2013SowetoSouth Africa
  • Fundación CENIT para la Investigación en Neurociencias

    Active, not recruiting

    C1125ABDArgentina
  • Santa Casa de Misericordia de Porto Alegre

    Active, not recruiting

    90020-090Rio Grande do SulBrazil
  • National Cancer Center

    Active, not recruiting

    10408Goyang-siSouth Korea
  • Severance Hospital, Yonsei University Health System

    Active, not recruiting

    03722SeoulSouth Korea
  • National Cancer Centre

    Active, not recruiting

    168583SingaporeSingapore
  • Hospital Universitario 12 de Octubre

    Active, not recruiting

    28041MadridSpain
  • Medical Park Seyhan Hospital

    Active, not recruiting

    01140AdanaTürkiye
  • Clinica De La Costa

    Completed

    080020BarranquillaColombia
  • Asan Medical Center

    Completed

    05505SeoulSouth Korea
  • Lumi Research

    Withdrawn

    77339HoustonUnited States
    Show trial locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Trial 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).

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT05894239, WO44263, 2022-502046-28-00 Trial Identifier
    All Gender
    ≥18 Years Age
    No Healthy Volunteers

    1.  Why is the WO44263 clinical trial needed?

    Standard treatment for people with HER2‑positive breast cancer that has grown and cannot be removed by surgery (locally advanced) or has spread to other parts of the body (metastatic) is chemotherapy with a combination of drugs called pertuzumab and trastuzumab (PH) named induction therapy, followed by maintenance therapy with PH. A drug called RO7198574 is a version of PH given as an injection under the skin. Some people have HER2-positive breast cancer that has a change, also called a mutation, in a gene called PIK3CA. Breast cancers with this type of mutation can get worse more quickly, so new therapies are needed to slow cancer growth. Drugs such as inavolisib block the activity of mutated PIK3CA to slow the growth of cancer cells and may make PH maintenance therapy work for longer. Inavolisib is an experimental drug – health authorities have not approved it as a treatment for breast cancer. This clinical trial aims to compare the effects, good or bad, of RO7198574 plus inavolisib versus RO7198574 plus placebo as maintenance therapy for people with PIK3CA‑mutated HER2‑positive breast cancer. 

     

    2. How does the WO44263 clinical trial work?

    This clinical trial is recruiting people with PIK3CA‑mutated HER2‑positive breast cancer that is locally advanced or metastatic. People who take part in this clinical trial (participants) must first be given the standard induction therapy (PH or RO7198574, plus a chemotherapy called a taxane). The clinical trial treatment RO7198574 plus inavolisib or RO7198574 plus placebo will then be given for as long as it stops cancer getting worse. The clinical trial doctor will see participants every week for the first month then once a month. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. Total time in the clinical trial will depend on how a participants’ cancer responds to treatment and could be from 1 day to 9 years or longer. Participants can stop trial treatment and leave the clinical trial at any time and will not lose access to their regular healthcare.

     

    3. What are the main endpoints of the WO44263 clinical trial?

    The main clinical trial endpoint (the main result measured in the trial to see if the drug has worked) is the amount of time between the start of the trial and participants’ cancer getting worse or the tumour getting bigger (known as ‘progression-free survival’).

    The other clinical trial endpoints include:

    • How long participants live (overall survival)
    • How many participants have a reduction in their tumour size or how much their cancer has progressed (known as ‘overall response rate’)
    • How much time passes between when participants’ cancer first responds to treatment and when their cancer gets worse (known as ‘duration of response’)
    • The number of participants who respond to treatment or have tumours that stay the same size for at least approximately 6 months (known as ‘clinical benefit rate')
    • The number and seriousness of any side effects
    • Change in health-related quality of life
    • How the body processes inavolisib 

     

    4. Who can take part in this clinical trial?

    People can take part in this trial if they are over the age of 18 and have PIK3CA‑mutated HER2‑positive breast cancer that is locally advanced or metastatic.

    People may not be able to take part in this trial if they have:

    ●        Previously received certain treatments for advanced HER2-positive breast cancer

    ●        Cancer that has spread to the brain or spinal cord and causes symptoms, and is untreated or is currently being treated with certain medicines

    ●        Certain other medical conditions such as heart, lung, liver or eye problems, diabetes, virus infections, or they are pregnant or breastfeeding or are planning to become pregnant during the trial or within 7 months after the final dose of RO7198574

     

    5. What treatment will participants be given in this clinical trial?

    After induction therapy, everyone will be given RO7198574 as an injection under the skin every 3 weeks, and either inavolisib OR placebo as a tablet (to be swallowed) daily. Participants will have an equal chance of being placed in either group. This is a ‘placebo-controlled’ clinical trial, which means that one of the groups will be given RO7198574 along with a substance with no active ingredients (known as a ‘placebo’); it looks like the drug being tested but does not contain any real medicine. Comparing results from the different groups helps the researchers know whether any changes seen result from the drug or occur by chance. This is a double-blinded trial, which means that neither the participant nor the clinical trial doctor can choose or know the group the participant is in, until the trial is over. This approach helps to prevent bias and expectations about what will happen. However, the participant’s clinical trial doctor can find out which group the participant is in, if their safety is at risk. 

     

    6. Are there any risks or benefits in taking part in this clinical trial?

    The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant. However, it may not be greater than the risks related to routine medical care or the natural progression of the health condition. People who would like to participate will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. All of these will be described in an informed consent document (a document that provides people with the information they need to decide to volunteer for the clinical trial).

    Risks associated with the clinical trial drugs

    Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe, even life-threatening, and vary from person to person. Participants will be closely monitored during the clinical trial and safety assessments will be performed regularly. Participants will be told about the known side effects of RO7198574 and inavolisib, and possible side effects based on human and laboratory studies or knowledge of similar drugs. RO7198574 will be given as an injection under the skin (subcutaneous injection). Participants will be told about any known side effects of subcutaneous injection. Inavolisib or placebo will be given as a tablet to be swallowed. Participants will be told about any known side effects of swallowing tablets.

    Potential benefits associated with the clinical trial

    Participants' health may or may not improve from participation in the clinical trial. Still, the information collected may help other people with similar medical conditions in the future.

    For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow this link to ClinicalTrials.gov: https://classic.clinicaltrials.gov/ct2/show/NCT05894239

     

    Trial 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).

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT05894239, WO44263, 2022-502046-28-00 Trial Identifier
    Inavolisib, Phesgo, Placebo, Taxane-based Chemotherapy, Optional Endocrine Therapy of Investigator's Choice Treatments
    Metastatic Breast Cancer Condition
    Official Title

    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

    Eligibility Criteria

    All Gender
    ≥18 Years Age
    No Healthy Volunteers
    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

    About Clinical Trials

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