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RECRUITING Phase 3 ClinicalTrials.gov

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT06790693

Registry updated: 2026-10-06
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Description

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Interventions

  • Inavolisib (Drug)
    Participants will receive oral inavolisib once daily (QD).
  • Placebo (Drug)
    Participants will receive oral placebo QD.
  • CDK4/6i (Drug)
    Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
  • Letrozole (Drug)
    Participants will receive oral letrozole QD.

Eligibility criteria

Inclusion Criteria: * Women or men with histologically or cytologically confirmed carcinoma of the breast * Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Documented HER2-negative tumor according to ASCO/CAP guidelines * De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment * Participants who have bilateral breast cancers which are both HR-positive and HER2-negative * Confirmation of biomarker eligibility * Consent to provide fresh or archival tumor tissue specimen * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate hematologic and organ function within 14 days prior to initiation of study treatment Exclusion Criteria: * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required * Metaplastic breast cancer * Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Any history of leptomeningeal disease or carcinomatous meningitis * Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible * Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye * Symptomatic active lung disease * History of or active inflammatory bowel disease * Any active bowel inflammation * Prior hematopoietic stem cell or bone marrow transplantation * Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

Conditions

Breast Cancer

Locations

  • City of Hope - Phoenix — Goodyear, Arizona, United States
  • The Dignity Health Cancer Institute — Phoenix, Arizona, United States
  • Disney Family Cancer Center — Burbank, California, United States
  • City of Hope - Lennar Foundation Cancer Center — Irvine, California, United States
  • Scripps Health — La Jolla, California, United States
  • City Of Hope — Long Beach, California, United States
  • Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
  • Ellison Medical Institute — Los Angeles, California, United States
  • Palo Alto Medical Foundation Research Center — Palo Alto, California, United States
  • Kaiser Permanente - San Marcos — San Marcos, California, United States
  • Palo Alto Medical Foundation Research Center — San Mateo, California, United States
  • Palo Alto Medical Foundation Research Center — Sunnyvale, California, United States
  • Cancer Specialists of North Florida - Jacksonville — Jacksonville, Florida, United States
  • Tallahassee Memorial HealthCare — Tallahassee, Florida, United States
  • Moffitt Cancer Center-McKinley Campus — Tampa, Florida, United States
  • Cleveland Clinic Florida — Weston, Florida, United States
  • Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
  • Cancer Care Specialists of Central Illinois — O'Fallon, Illinois, United States
  • Springfield Clinic — Springfield, Illinois, United States
  • Carle Cancer Center — Urbana, Illinois, United States
  • City of Hope® Cancer Center Chicago — Zion, Illinois, United States
  • Baptist Health Lexington — Lexington, Kentucky, United States
  • Baptist Health Hamburg — Lexington, Kentucky, United States
  • University of Kentucky - Markey Cancer Center — Lexington, Kentucky, United States
  • University of Louisville Hospital — Louisville, Kentucky, United States
  • Baptist Health Louisville — Louisville, Kentucky, United States
  • Velocity Clinical Research — Annapolis, Maryland, United States
  • University of Maryland — Baltimore, Maryland, United States
  • Henry Ford Health System — Detroit, Michigan, United States
  • Cancer & Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
  • University of Minnesota Medical Center — Minneapolis, Minnesota, United States
  • HCA Midwest Health — Kansas City, Missouri, United States
  • Nebraska Cancer Specialists — Grand Island, Nebraska, United States
  • Nebraska Cancer Specialists — Omaha, Nebraska, United States
  • Astera Cancer Care East Brunswick — East Brunswick, New Jersey, United States
  • Summit Medical Group — Florham Park, New Jersey, United States
  • The Blavatnik Family ? Chelsea Medical Center at Mount Sinai — New York, New York, United States
  • Mount Sinai West — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • New York Cancer & Blood Specialists — Shirley, New York, United States
  • Montefiore Medical Center — The Bronx, New York, United States
  • Novant Health Cancer Institute — Charlotte, North Carolina, United States
  • Duke Cancer Institute — Durham, North Carolina, United States
  • Novant Health Cancer Institute — Winston-Salem, North Carolina, United States
  • Fairview Hospital — Cleveland, Ohio, United States
  • Cleveland Clinic Foundation — Cleveland, Ohio, United States
  • Hillcrest Hospital — Mayfield Heights, Ohio, United States
  • Providence Portland Medical Center — Portland, Oregon, United States
  • Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy — Portland, Oregon, United States
  • UPMC Hillman Cancer Center - Magee-Women?s Hospital — Pittsburgh, Pennsylvania, United States
  • Bon Secours - St. Francis Hospital — Greenville, South Carolina, United States
  • West Cancer Center — Germantown, Tennessee, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • JPS Health Network — Fort Worth, Texas, United States
  • Community Clinical Trials — Spring, Texas, United States
  • Huntsman Cancer Hospital at the University of Utah — Salt Lake City, Utah, United States
  • Swedish Cancer Institute - Edmonds Campus — Edmonds, Washington, United States
  • Providence Regional Cancer Partnership — Everett, Washington, United States
  • Swedish Cancer Institute - Issaquah — Seattle, Washington, United States
  • Swedish Cancer Institute — Seattle, Washington, United States
  • Northwest Medical Specialties — Tacoma, Washington, United States
  • Centro Oncologico Korben — Caba, Argentina
  • Centro Médico Fleischer — Capital Federal, Argentina
  • Hospital Privado Centro Medico de Cordoba — Córdoba, Argentina
  • Instituto de Oncologia de Rosario — Rosario, Argentina
  • Centro Oncológico de Excelencia — San Juan, Argentina
  • Blacktown Hospital — Blacktown, New South Wales, Australia
  • Royal North Shore Hospital — St Leonards, New South Wales, Australia
  • Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia
  • Monash Health — Clayton, Victoria, Australia
  • Maroondah hospital;Oncology clinical trials — Ringwood, Victoria, Australia
  • Crio - Centro Regional Integrado de Oncologia — Fortaleza, Ceará, Brazil
  • Hospital Santa Rita de Cassia Vitoria — Vitória, Espírito Santo, Brazil
  • Obras Sociais Irma Dulce - Osid — Salvador, Estado de Bahia, Brazil
  • Hospital Araujo Jorge — Goiânia, Goiás, Brazil
  • Centro de Oncologia de Alfenas — Alfenas, Minas Gerais, Brazil
  • Hospital do Câncer de Londrina — Londrina, Paraná, Brazil
  • Hospital do Cancer de Pernambuco - HCP — Recife, Pernambuco, Brazil
  • Vencer Oncoclínica - Centro de Pesquisa do Piauí — Teresina, Piauí, Brazil
  • Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
  • Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil
  • Instituto do Cancer do Estado de Sao Paulo - ICESP — São Paulo, São Paulo, Brazil
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo, Brazil
  • Instituto Nacional de Cancer - INCa — Rio de Janeiro, Brazil
  • Arthur J.E. Child Comprehensive Cancer Center — Calgary, Alberta, Canada
  • Cross Cancer Institute — Edmonton, Alberta, Canada
  • CancerCare Manitoba — Winnipeg, Manitoba, Canada
  • The Moncton Hospital — Moncton, New Brunswick, Canada
  • The Ottawa Hospital Cancer Center — Ottawa, Ontario, Canada
  • Sault Area Hospital — Sault Ste. Marie, Ontario, Canada
  • Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
  • St. Joseph's Health Centre — Toronto, Ontario, Canada
  • Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec, Canada
  • Jewish General Hospital — Montreal, Quebec, Canada
  • Hôpital du Sacré-Coeur de Montreal — Montreal, Quebec, Canada
  • Unité de Recherche Clinique du CISSS de Laurentides — Saint-Jérôme, Quebec, Canada
  • Xiangyang Central Hospital — Xiangyang, Hubei, China
  • Peking Union Medical College Hospital — Beijing, China
  • Hunan Cancer Hospital — Changsha, China
  • West China Hospital of Sichuan University — Chengdu, China
  • Sichuan Provincial People's Hospital — Chengdu, China
  • Sun yat-sen University Cancer Center — Guangzhou, China
  • Sun Yat-Sen University Cancer Center - Huangpu Campus — Guangzhou, China
  • Zhejiang Cancer Hospital — Hangzhou, China
  • Harbin Medical University Cancer Hospital — Harbin, China
  • Jiangmen Central Hospital — Jiangmen, China
  • Shandong Cancer Hospital — Jinan, China
  • Jinhua municipal central hospital — Jinhua, China
  • Yunnan Cancer Hospital — Kunming, China
  • Guangxi Cancer Hospital of Guangxi Medical University — Nanning, China
  • Shantou Center Hospital — Shantou, China
  • Tianjin Cancer Hospital — Tianjin, China
  • Tianjin Cancer hospital Airport hospital — Tianjin, China
  • Xinjiang Medical University Cancer Hospital — Ürümqi, China
  • The Second Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, China
  • Shanxi Provincial People's Hospital — Xi'an, China
  • ICO Paul Papin — Angers, France
  • Centre Oscar Lambret — Lille, France
  • Centre Cancerologie Grand Montpellier — Montpellier, France
  • INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale. — Paris, France
  • Centre CARIO - HPCA — Plérin, France
  • Chu La Miletrie — Poitiers, France
  • Centre Eugene Marquis — Rennes, France
  • Centre Henri Becquerel — Rouen, France
  • HOPITAL RENE HUGUENIN- Institut Curie — Saint-Cloud, France
  • Ico Rene Gauducheau — Saint-Herblain, France
  • Institut Universitaire de Cancer de Toulouse Oncopole — Toulouse, France
  • Gustave Roussy — Villejuif, France
  • St. Elisabeth Krankenhaus Köln GmbH — Cologne, Germany
  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden — Dresden, Germany
  • Universitätsklinikum Essen — Essen, Germany
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH — Essen, Germany
  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem — Hamburg, Germany
  • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie — Hanover, Germany
  • Nationales Centrum für Tumorerkrankungen (NCT) — Heidelberg, Germany
  • InVO - Institut für Versorgungsforschung in der Onkologie GbR — Koblenz, Germany
  • Dres. Andreas Köhler und Roswitha Fuchs — Langen, Germany
  • Universitätsklinikum Münster — Münster, Germany
  • Klinikum Ernst von Bergmann — Potsdam, Germany
  • Caritas-Krankenhaus St. Josef — Regensburg, Germany
  • Caritas Klinik St. Theresia -Frauenklinik Brustzentrum — Saarbrücken, Germany
  • Universitätsklinik Tübingen — Tübingen, Germany
  • Universitätsklinikum Ulm Am Michelsberg — Ulm, Germany
  • Az. Osp. G. Panico — Tricase (LE), Apulia, Italy
  • A.O. S. Anna e San Sebastiano — Caserta, Campania, Italy
  • A.O. Universitaria Federico II Di Napoli — Naples, Campania, Italy
  • U.O.C. Oncologia Medica Senologica — Naples, Campania, Italy
  • Policlinico S.Orsola-Malpighi — Bologna, Emilia-Romagna, Italy
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola — Meldola, Emilia-Romagna, Italy
  • A.O. Universitaria Policlinico Di Modena — Modena, Emilia-Romagna, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Lazio, Italy
  • Asst Papa Giovanni XXIII — Bergamo, Lombardy, Italy
  • Ospedale San Raffaele — Milan, Lombardy, Italy
  • Irccs Istituto Nazionale Dei Tumori (Int) — Milan, Lombardy, Italy
  • Istituto Clinico Humanitas — Rozzano, Lombardy, Italy
  • Humanitas Centro Catanese Di Oncologia — Misterbianco (CT), Sicily, Italy
  • Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia Medic — Bolzano, Trentino-Alto Adige, Italy
  • Ospedale Civile - Livorno — Livorno, Tuscany, Italy
  • University of Eastern Piedmont - Maggiore della Carità University Hospital — Novara, Umbria, Italy
  • A.O. Santa Maria Terni — Terni, Umbria, Italy
  • Aichi Cancer Center — Aichi, Japan
  • Chiba Cancer Center — Chiba, Japan
  • Fukushima Medical University Hospital — Fukushima, Japan
  • Hiroshima University Hospital — Hiroshima, Japan
  • Hokkaido University Hospital — Hokkaido, Japan
  • Kanagawa Cancer Center — Kanagawa, Japan
  • Tokai University Hospital — Kanagawa, Japan
  • Okayama University Hospital — Okayama, Japan
  • Saitama Medical University International Medical Center — Saitama, Japan
  • The Cancer Inst. Hosp. of JFCR — Tokyo, Japan
  • Instituto Nacional De Cancerologia — Distrito Federal, Mexico CITY (federal District), Mexico
  • Hospital General de Mexico — MexicoCiudad de México, Nuevo León, Mexico
  • Hospital Zambrano Hellion TecSalud — Monterrey, Nuevo León, Mexico
  • Centro de Investigacion y Tratamiento Integral del Cancer: CITI Cancer Oaxaca S.A de C.V. — Ciudad de Huajuapan de León, Oaxaca, Mexico
  • Centro de Investigacion Clinica de Oaxaca — Oaxaca City, Oaxaca, Mexico
  • Centro Estatal de Cancerologia de Chihuahua — Chihuahua City, Mexico
  • Iem-Fucam — D.F., Mexico
  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Mexico
  • Instytut "Centrum Zdrowia Matki Polki" — ?ód?, Poland
  • Bialostockie Centrum Onkologii — Bialystok, Poland
  • Przychodnia Lekarska KOMED, Roman Karaszewski — Konin, Poland
  • Szpital Wojewódzki im. Miko?aja Kopernika — Koszalin, Poland
  • Szpital Miejski Specjalistyczny Narutowicza — Krakow, Poland
  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej — Lublin, Poland
  • Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie — Późna, Poland
  • MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie — Rzeszów, Poland
  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad — Warsaw, Poland
  • Dolno?l?skie Centrum Onkologii — Wroc?aw, Poland
  • PanOncology Trials — San Juan, Puerto Rico
  • Linksfield Oncology Inc. — Johannesburg, South Africa
  • Abraham Oncology — Richards Bay, South Africa
  • Wits Clinical Research — Soweto, South Africa
  • Kyungpook National University Chilgok Hospital — Daegu, South Korea
  • Soon Chun Hyang University Cheonan Hospital — Dongnam-gu, Cheonan-si, South Korea
  • National Cancer Center — Goyang-si, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Gangnam Severance Hospital — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Hospital General Universitario de Elche — Elche, Alicante, Spain
  • ICO L'Hospitalet — L'Hospitalet de Llobregat, Barcelona, Spain
  • Hospital de Navarra — Pamplona/iruña, Navarre, Spain
  • Hospital de Basurto — Bilbao, Vizcaya, Spain
  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona — Barcelona, Spain
  • Hospital Universitario de la Princesa — Madrid, Spain
  • IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica — Madrid, Spain
  • Hospital General Univ. Gregorio Maranon — Madrid, Spain
  • Hospital Universitario Infanta Leonor — Madrid, Spain
  • Hospital Universitario Clínico San Carlos — Madrid, Spain
  • Hospital Universitario 12 De Octubre — Madrid, Spain
  • Hospital Clinico Universitario Virgen de la Victoria;Servicio de Oncologia — Málaga, Spain
  • Hospital Universitario Virgen del Rocio — Seville, Spain
  • Fundacion Instituto Valenciano de Oncologia (IVO) — Valencia, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
  • Kantonsspital Baden Zentrum für Onkologie und Hämatologie — Baden, Switzerland
  • Universitätsspital Basel — Basel, Switzerland
  • CHUV — Lausanne, Switzerland
  • Luzerner Kantonsspital — Lucerne, Switzerland
  • Chia-Yi Christian Hospital — Chiayi City, Taiwan
  • Taichung Veterans General Hospital — Taichung, Taiwan
  • National Cheng Kung Uni Hospital — Tainan, Taiwan
  • National Taiwan Uni Hospital — Taipei, Taiwan
  • Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Abdurrahman Yurtarslan Onkoloji Training and Research Hospital — Ankara, Turkey (Türkiye)
  • Ankara City Hospital — Ankara, Turkey (Türkiye)
  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji — Bakirkoy / Istanbul, Turkey (Türkiye)
  • Ba?c?lar Medipol Mega Üniversite Hastanesi — Istanbul, Turkey (Türkiye)
  • Izmir Ataturk Training and Research Hospital — Izmir, Turkey (Türkiye)
  • Mersin City Education and Research Hospital — Mersin, Turkey (Türkiye)
  • Blackpool Victoria Hospital — Blackpool, United Kingdom
  • Colchester General Hospital — Colchester, Essex, United Kingdom
  • Western General Hospital — Edinburgh, United Kingdom
  • Princess Alexandra Hospital — Harlow, United Kingdom
  • St Bartholomew's Hospital — London, United Kingdom
  • Royal Free Hospital — London, United Kingdom
  • Mount Vernon & Watford Hospital Trust — Northwood, United Kingdom
  • Churchill Hospital - Oxford Cancer & Haematology Centre — Oxford, United Kingdom
  • Weston Park Hospital — Sheffield, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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