A study to compare standard treatment plus inavolisib or a non-active placebo in people with PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer that has spread in the body

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

  • Cancer
  • Breast Cancer
  • Breast Cancer Er‑Positive
  • 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:

Active, not recruiting

This trial runs in
Countries
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Georgia
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Malaysia
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Türkiye
  • Ukraine
  • United Kingdom
  • United States
Trial Identifier:

NCT04191499 2019-002455-42 2023-505812-39-00 WO41554

  • Beverly Hills Cancer Center

    90211Beverly HillsUnited States
  • Winship Cancer Institute of Emory University

    30322AtlantaUnited States
  • Massachusetts General Hospital.

    02114BostonUnited States
  • Memorial Sloan Kettering Cancer Center

    10065New YorkUnited States
  • Wake Forest University Baptist Medical Center

    27157Winston-SalemUnited States
  • Sarah Cannon Research Institute / Tennessee Oncology

    37404ChattanoogaUnited States
  • Sarah Cannon Research Institute / Tennessee Oncology

    37203NashvilleUnited States
  • Texas Oncology - Central South

    78731AustinUnited States
  • Texas Tech University Health Sciences Center; Department of Internal Medicine

    79905El PasoUnited States
  • Texas Oncology - Northeast Texas

    75702TylerUnited States
  • Northwest Medical Specialties

    98405TacomaUnited States
  • Fundación CENIT para la Investigación en Neurociencias

    C1125ABDArgentina
  • Centro Oncologico Korben; Oncology

    C1425Buenos AiresArgentina
  • Hosp Provincial D. Centenarios; Oncology Dept

    S2000RosarioArgentina
  • Macquarie University Hospital

    2113Macquarie UniversityAustralia
  • Westmead Hospital; Medical Oncology and Pallative Care

    2145WestmeadAustralia
  • Southern Medical Day Care Centre

    2500WollongongAustralia
  • Mater Adult Hospital; Oncology

    4101South BrisbaneAustralia
  • Princess Alexandra Hospital; Cancer Trials Unit

    4102WoolloongabbaAustralia
  • Western Health

    3065FitzroyAustralia
  • Peninsula and South Eastern Haematology and Oncology Group

    3199FrankstonAustralia
  • UZ Leuven Gasthuisberg

    3000LeuvenBelgium
  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama

    74605-070GoiásBrazil
  • Santa Casa de Misericordia de Porto Alegre

    90020-090Rio Grande do SulBrazil
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    01317-001São PauloBrazil
  • Tom Baker Cancer Centre-Calgary

    T2N 4N2CalgaryCanada
  • London Regional Cancer Program, London Health Sciences Centre, Baines Centre

    N6A 5W9LondonCanada
  • Ottawa Hospital

    K1H 8L6OttawaCanada
  • Princess Margaret Cancer Center

    M5G 2C4TorontoCanada
  • Hopital du Saint Sacrement

    G1S 4L8QuébecCanada
  • Beijing Cancer Hospital

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

    130021chang-chun-shiChina
  • West China Hospital, Sichuan University

    610041Cheng Du ShiChina
  • The First Affiliated Hospital, Chongqing Medical University

    400016chong-qing-shiChina
  • Fujian Medical University Union Hospital

    350001fu-zhou-shiChina
  • Sun Yet-sen University Cancer Center

    510060guang-zhou-shiChina
  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

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

    150081HarbinChina
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    210029nan-jing-shiChina
  • Fudan University Shanghai Cancer Center; Medical Oncology

    201315ShanghaiChina
  • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

    050010shi-jia-zhuang-shiChina
  • Tianjin Cancer Hospital

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

    430023WuhanChina
  • Hubei Cancer Hospital

    430079wu-han-shiChina
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    710049xi-an-shiChina
  • Henan Cancer Hospital

    450003zheng-zhou-shiChina
  • Vejle Sygehus; Onkologisk Afdeling

    7100VejleDenmark
  • Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

    63000Clermont-FerrandFrance
  • Centre Georges Francois Leclerc; Oncologie 3

    21000DijonFrance
  • Centre Oscar Lambret; Senologie

    59020LilleFrance
  • Hopital Dupuytren; Oncologie Medicale

    87000LimogesFrance
  • Hopital Prive Jean Mermoz; Cancerologie

    69008LyonFrance
  • Institut régional du Cancer Montpellier

    34090MontpellierFrance
  • Institut Universitaire du Cancer de Toulouse-Oncopole

    31100ToulouseFrance
  • Acad. F. Todua Medical Center

    0112T'bilisiGeorgia
  • Israel-Georgian Medical Research Clinic Healthycore

    0112TbilisiGeorgia
  • Cancer Research Centre

    0159TbilisiGeorgia
  • Tbilisi Oncology Dispensary

    0159TbilisiGeorgia
  • Multiprofile Clinic Consilium Medulla

    0186TbilisiGeorgia
  • S Khechinashvili University Clinic Ltd

    179T'bilisiGeorgia
  • Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

    13581BerlinGermany
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

    45136EssenGermany
  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

    69120HeidelbergGermany
  • Universitätsklinikum Mannheim; Frauenklinik

    68167MannheimGermany
  • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

    54290TrierGermany
  • Universitätsfrauenklinik Ulm; Abteilung Gynäkologie

    89075UlmGermany
  • Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

    115 22Greece
  • Univ General Hosp Heraklion; Medical Oncology

    711 10IraklioGreece
  • Euromedical General Clinic of Thessaloniki; Oncology Department

    546 45ThessalonikiGreece
  • Queen Mary Hospital; Dept of Medicine

    Hong Kong IslandHong Kong
  • Prince of Wales Hospital; Department of Clinical Onocology

    New TerritoriesHong Kong
  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

    1122BudapestHungary
  • Uzsoki Utcai Korhaz; Onkoradiológiai Osztály

    212BudapestHungary
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

    5000SzolnokHungary
  • Azienda Ospedaliera Universitaria Federico II

    80131NapoliItaly
  • A.O. Universitaria Di Parma

    43126ParmaItaly
  • Irccs Centro Di Riferimento Oncologico (CRO)

    33081c-r-o--ospedaleItaly
  • Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

    25123BresciaItaly
  • Fondazione IRCCS Istituto Nazionale dei Tumori

    20133MilanoItaly
  • Ospedale Santa Maria Annunziata; Oncologia

    50012grassinaItaly
  • Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2

    56124PisaItaly
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

    35128PadovaItaly
  • Pusan National University Hospital

    602-739BusanSouth Korea
  • Kyungpook National University Medical Center

    41404DaeguSouth Korea
  • National Cancer Center

    10408Goyang-siSouth Korea
  • Seoul National University Bundang Hospital

    463-707Seongnam-siSouth Korea
  • Korea University Anam Hospital

    02841SeoulSouth Korea
  • Seoul National University Hospital

    03080SeoulSouth Korea
  • Severance Hospital, Yonsei University Health System

    03722SeoulSouth Korea
  • Asan Medical Center

    05505SeoulSouth Korea
  • Gangnam Severance Hospital

    06273SeoulSouth Korea
  • Samsung Medical Center

    06351SeoulSouth Korea
  • Ewha Womans University Mokdong Hospital

    07985SeoulSouth Korea
  • National Cancer Institute IKN

    62250PutrajayaMalaysia
  • Hospital Sultan Ismail; Oncology

    81100Johor BahruMalaysia
  • Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

    93586KuchingMalaysia
  • Palmerston North Hospital; Regional Cancer Treatment Service

    4442Palmerston NorthNew Zealand
  • Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi

    44-102GliwicePoland
  • Przychodnia Lekarska KOMED, Roman Karaszewski

    62-500KoninPoland
  • Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym

    45-061OpolePoland
  • Lecznice Citomed Sp. z o.o.

    87-100ToruńPoland
  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

    00-001WarszawaPoland
  • Centro Clinico Champalimaud; Oncologia Medica

    1400-038LisboaPortugal
  • IPO do Porto; Servico de Oncologia Medica

    4200-072PortoPortugal
  • Moscow Clinical Scientific Center

    111123Moscow OblastRussia
  • Blokhin Cancer Research Center; Out-Patients Dept

    115552MoscowRussia
  • MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

    143422Moscow OblastRussia
  • LLC Medscan

    119421Moscow OblastRussia
  • Clinical Hospital Lapino (LLC Haven)

    143081lapinoRussia
  • Medical Clinic "AB Medical group"

    195248Sankt-PeterburgRussia
  • Volgograd Regional Clinical Oncology Dispensary

    400138volgogradRussia
  • Regional Clinical Oncology Hospital

    150040YaroslavlRussia
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)

    119074SingaporeSingapore
  • National Cancer Centre; Medical Oncology

    168583SingaporeSingapore
  • Hospital General Universitario de Elche; Servicio de Oncologia

    03203ElcheSpain
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    08916BadalonaSpain
  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia

    28222MajadahondaSpain
  • Clinica Universitaria de Navarra; Servicio de Oncologia

    31008PamplonaSpain
  • Hospital Universitario de Canarias;servicio de Oncologia

    38320La LagunaSpain
  • Hospital del Mar; Servicio de Oncologia

    08003BarcelonaSpain
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    08035BarcelonaSpain
  • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

    08036BarcelonaSpain
  • Insituto Catalán de Oncologia (ICO)

    08907L'Hospitalet de LlobregatSpain
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

    23007JaénSpain
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    28007MadridSpain
  • Clinica Universidad de Navarra-Madrid

    28027MadridSpain
  • Hospital Clinico San Carlos; Servicio de Oncologia

    28040MadridSpain
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    28041MadridSpain
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia

    41009SevillaSpain
  • Instituto Valenciano Oncologia; Oncologia Medica

    46009ValènciaSpain
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    46010ValènciaSpain
  • Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

    80756Kaohsiung CityTaiwan
  • Chi-Mei Medical Centre; Hematology & Oncology

    710Tainan CityTaiwan
  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

    112Taipei CityTaiwan
  • VETERANS GENERAL HOSPITAL; Department of General Surgery

    112Taipei CityTaiwan
  • National Taiwan Uni Hospital; General Surgery

    100Taipei CityTaiwan
  • Tri-Service General Hospital, Division of General Surgery

    333Taoyuan CityTaiwan
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

    10400Krung Thep Maha NakhonThailand
  • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

    50200Chang Wat Chiang MaiThailand
  • Chulabhorn Hospital; Medical Oncology

    10210Krung Thep Maha NakhonThailand
  • Songklanagarind Hospital; Department of Oncology

    90110tambon-kho-hongThailand
  • Adana Baskent University Hospital; Medical Oncology

    01240AdanaTürkiye
  • Gulhane Training and Research Hospital

    06010AnkaraTürkiye
  • Ege University Medical Faculty; Medical Oncology Department

    35100İzmirTürkiye
  • Istanbul University Cerrahpasa Faculty of Medicine

    34098İstanbulTürkiye
  • Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

    34384İstanbulTürkiye
  • SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department

    61018KharkivUkraine
  • Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2

    76000Ivano-Frankivs'kUkraine
  • Uzhhorod Central City Clinical Hospital

    88000UzhhorodUkraine
  • City Clinical Hospital #4

    49000DniproUkraine
  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department

    50000Kryvyi RihUkraine
  • Kyiv City Clinical Oncological Center

    03115KyivUkraine
  • RCI Sumy Regional Clinical Oncological Dispensary

    40000SumyUkraine
  • Princess Alexandra Hospital; Oncology Department

    CM20 1QXHarlowUnited Kingdom
  • Barts Health NHS Trust; Cancer Research Delivery Group

    E1 1BBLondonUnited Kingdom
  • St Georges University Hospitals NHS Foundation Trust

    SW17 0QTLondonUnited Kingdom
  • Churchill Hospital; Department of Oncology

    OX3 7LEOxfordUnited Kingdom
  • Peterborough City Hospital, Edith Cavell Campus; Oncology Department

    PE3 9GZPeterboroughUnited Kingdom
  • Derriford Hospital

    PL6 8DHPlymouthUnited Kingdom
    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, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

    Hoffmann-La Roche Sponsor
    Phase 2/Phase 3 Phase
    NCT04191499, WO41554, 2019-002455-42, 2023-505812-39-00 Trial Identifier
    All Gender
    ≥18 Years Age
    No Healthy Volunteers

    1. Why is this study needed?

    Hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer is a type of cancer that starts in the breast. It is made up of cells that have extra hormone receptors but not extra HER2. These cells can grow more quickly than healthy cells in response to the hormones oestrogen and progesterone. Breast cancer can spread to nearby tissue (known as ‘locally advanced cancer’) and to other parts of the body (known as ‘metastatic cancer’).

    Standard treatment for people with HR+ and HER2- breast cancer that has spread can include medicines called CDK4/6 inhibitors (such as palbociclib) and hormone blockers (such as fulvestrant). Some people have breast cancer that also has a change (mutation) in a small section of DNA called a gene, so that the gene is different from what is found in healthy cells. Standard treatments often do not work as well for people with breast cancer that has changes in a gene called ‘PIK3CA’, so better treatments are needed.

    This study is testing a medicine called inavolisib, combined with standard treatment. It is being developed to treat PIK3CA-mutated, HR-positive, HER2-negative breast cancer. Since this study started, inavolisib combined with palbociclib and fulvestrant has been approved by the U.S. Food and Drug Administration for treating this type of breast cancer if it worsened during or after finishing hormone therapy.

    This study aims to continue to compare how well standard treatment plus inavolisib works versus standard treatment plus non-active ‘placebo’ in people with PIK3CA HR+ HER2- breast cancer that has spread.

    2. Who can take part in the study?

    People of at least 18 years of age with PIK3CA-mutated, HR+, HER2- breast cancer that has spread can take part in the study if their cancer worsened during or within 1 year of finishing a previous hormone therapy. People may not be able to take part in this study if they have previously had certain treatments, such as those similar to inavolisib, fulvestrant if given after breast cancer surgery, or any previous treatment for breast cancer that has spread in the body. People may also not take part if they have certain other medical conditions, such as diabetes, lung or heart disease, or certain infections. People who are pregnant or currently breastfeeding cannot take part in the study.

    3. How does this study work?

    People will be screened to check if they are able to participate in the study. The screening period will take place from 1 month before the start of treatment.

    Everyone who joins this study will be placed into 1 of the 2 groups randomly (like flipping a coin) and given either:

    • Inavolisib, given as a tablet (to be swallowed) every day plus palbociclib, given as daily capsules or tablets for three weeks of each month and fulvestrant, given as an injection into a muscle once a month
      OR
    • Placebo given as a tablet (to be swallowed) every day plus palbociclib, given as daily capsules or tablets for three weeks of each month and fulvestrant, given as an injection into a muscle once a month

    Participants will have an equal chance of being placed in either group.

    This is a ‘placebo-controlled’ study. This means that participants are put in a group that will receive a medicine or a group that will receive ‘placebo’ (a medicine that contains no active ingredients but looks the same and is taken in the same way as the study medicine). Comparing results from the different groups helps researchers know if any changes seen result from the study medicine or occur by chance.

    This is a double-blinded study. This means that neither the participants in the study nor the team running it will know which treatment is being given until the study is over. This is done to make sure that the results of the treatment are not affected by what people expected from the received treatment. However, the study doctor can find out which group the participant is in, if the participants' safety is at risk.

    During this study, the study doctor will see participants approximately weekly during the first month and then about once per month while they are receiving treatment. The study doctor will see how well the treatment is working and any unwanted effects participants may have. Participants will have a follow-up visit 1 month after completing the study treatment, then visits or telephone calls every 2 to 3 months, during which the study doctor will check on the participant’s wellbeing. Total duration of the study could be more than 5 years, depending on how well a participant responds to treatment. Participants have the right to stop study treatment and leave the study at any time, if they wish to do so.

    4. What are the main results measured in this study?

    The main result measured in the study to assess if the medicine has worked is how long participants live without their cancer getting worse.

    Other key results measured in the study include:

    • How many participants have a reduction of their cancer after treatment
    • How many participants have a positive response to the treatment and how long this response lasts
    • The number of participants whose tumours shrink or stay the same for at least 6 months with study treatment
    • How long people live
    • The time it takes for a participant to have a significant worsening in certain measures (such as pain, impact of their symptoms on daily life and their ability to function and enjoy life, or being able to do daily activities)
    • The number and seriousness of unwanted effects
    • How the study treatments get to different parts of the body, and how the body changes and gets rid of them

    5. Are there any risks or benefits in taking part in this study?

    Taking part in the study may or may not make participants feel better. But the information collected in the study can help other people with similar health conditions in the future.

    It may not be fully known at the time of the study how safe and how well the study treatment works. The study involves some risks to the participant. But these risks are generally not greater than those related to routine medical care or the natural progression of the health condition. People interested in taking part will be informed about the risks and benefits, as well as any additional procedures or tests they may need to undergo. All details of the study will be described in an informed consent document. This includes information about possible effects and other options of treatment.

    Risks associated with inavolisib, palbociclib, and fulvestrant

    Participants may have unwanted effects from the medicines used in this study. These unwanted effects can be mild to severe, even life-threatening, and vary from person to person. During this study, participants will have regular check-ups to see if there are any unwanted effects.

    Participants will be told about the known unwanted effects of inavolisib, palbociclib, and fulvestrant and possible unwanted effects based on human and laboratory studies or knowledge of similar medicines. Known unwanted effects include a high level of sugar in the blood, feeling tired or weak, wanting to throw up, throwing up, and swelling or ulcers in the mouth or lips. Known unwanted effects of an injection into a muscle include soreness, redness, swelling, or rash on the skin where it has been pricked with a needle to give a treatment or draw blood samples. The study medicines may be harmful to an unborn baby. Women and men must take precautions to avoid exposing an unborn baby to the study treatment.

    Trial Summary

    This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

    Hoffmann-La Roche Sponsor
    Phase 2/Phase 3 Phase
    NCT04191499, WO41554, 2019-002455-42, 2023-505812-39-00 Trial Identifier
    Inavolisib, Placebo, Palbociclib, Fulvestrant Treatments
    Breast Cancer Condition
    Official Title

    A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

    Eligibility Criteria

    All Gender
    ≥18 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Confirmed diagnosis of HR+/HER2- breast cancer
    • Metastatic or locally advanced disease not amenable to curative therapy
    • Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
    • Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
    • Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
    • Consent to provide fresh or archival tumor tissue specimen
    • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
    • Eastern Cooperative Oncology Group Performance Status of 0 or 1
    • Life expectancy of > 6 months
    • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
    Exclusion Criteria
    • Metaplastic breast cancer
    • Any history of leptomeningeal disease or carcinomatous meningitis
    • Any prior systemic therapy for metastatic breast cancer
    • Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
    • Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
    • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
    • Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
    • Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
    • Symptomatic active lung disease, or requiring daily supplemental oxygen
    • History of inflammatory bowel disease or active bowel inflammation
    • Anti-cancer therapy within 2 weeks before study entry
    • Investigational drug(s) within 4 weeks before randomization
    • Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
    • Chronic corticosteroid therapy or immunosuppressants
    • Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
    • Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

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