Breast CancerPhase 3INAVO123NCT06790693
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
A Phase 3 study testing Inavolisib, CDK4/6i and Letrozole in people with Breast Cancer, run by Hoffmann-La Roche at 242 sites in 20 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Inavolisib, CDK4/6i and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 242 sitesin 20 countries
- Study dates
- 9 Apr 2025to 1 Feb 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
242 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WO45654 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
242 sites in 20 countries
United States62 sites, 62 recruiting
- Recruiting
Velocity Clinical Research
Annapolis, Maryland, 21401
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
- Recruiting
Disney Family Cancer Center
Burbank, California, 91505
- Recruiting
Novant Health Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
Fairview Hospital
Cleveland, Ohio, 44111
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44915
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
- Recruiting
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816
- Recruiting
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, 98026
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201-1621
- Recruiting
Summit Medical Group
Florham Park, New Jersey, 07932
- Recruiting
JPS Health Network
Fort Worth, Texas, 76104
- Recruiting
West Cancer Center
Germantown, Tennessee, 38138
- Recruiting
City of Hope - Phoenix
Goodyear, Arizona, 85338
- Recruiting
Nebraska Cancer Specialists
Grand Island, Nebraska, 68803
- Recruiting
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
- Recruiting
Bon Secours - St. Francis Hospital
Greenville, South Carolina, 29607
- Recruiting
City of Hope - Lennar Foundation Cancer Center
Irvine, California, 92618
- Recruiting
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida, 32207
- Recruiting
HCA Midwest Health
Kansas City, Missouri, 64132
- Recruiting
Scripps Health
La Jolla, California, 92040
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
- Recruiting
Baptist Health Hamburg
Lexington, Kentucky, 40509
- Recruiting
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, 40536
- Recruiting
City Of Hope
Long Beach, California, 90813
- Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
- Recruiting
Ellison Medical Institute
Los Angeles, California, 90064
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
- Recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
- Recruiting
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060
- Recruiting
Hillcrest Hospital
Mayfield Heights, Ohio, 44124
- Recruiting
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
- Recruiting
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
New York, New York, 10011
- Recruiting
Mount Sinai West
New York, New York, 10019
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, 62269
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130-2042
- Recruiting
Palo Alto Medical Foundation Research Center
Palo Alto, California, 94301
- Recruiting
The Dignity Health Cancer Institute
Phoenix, Arizona, 85004
- Recruiting
UPMC Hillman Cancer Center - Magee-Women?s Hospital
Pittsburgh, Pennsylvania, 15213
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
- Recruiting
Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy
Portland, Oregon, 97225
- Recruiting
Huntsman Cancer Hospital at the University of Utah
Salt Lake City, Utah, 84113
- Recruiting
Kaiser Permanente - San Marcos
San Marcos, California, 92069
- Recruiting
Palo Alto Medical Foundation Research Center
San Mateo, California, 94401
- Recruiting
Swedish Cancer Institute - Issaquah
Seattle, Washington, 98104
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
- Recruiting
New York Cancer & Blood Specialists
Shirley, New York, 11967
- Recruiting
Community Clinical Trials
Spring, Texas, 77389
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
- Recruiting
Palo Alto Medical Foundation Research Center
Sunnyvale, California, 94086
- Recruiting
Northwest Medical Specialties
Tacoma, Washington, 98405
- Recruiting
Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308
- Recruiting
Moffitt Cancer Center-McKinley Campus
Tampa, Florida, 33612
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
- Recruiting
Novant Health Cancer Institute
Winston-Salem, North Carolina, 27103
- Recruiting
City of Hope® Cancer Center Chicago
Zion, Illinois, 60099
China20 sites, 20 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100032
- Recruiting
Hunan Cancer Hospital
Changsha, 410013
- Recruiting
West China Hospital of Sichuan University
Chengdu, 610041
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
- Recruiting
Sun yat-sen University Cancer Center
Guangzhou, 510060
- Recruiting
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
- Recruiting
Jiangmen Central Hospital
Jiangmen, 529030
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
- Recruiting
Jinhua municipal central hospital
Jinhua, 321083
- Recruiting
Yunnan Cancer Hospital
Kunming, 650118
- Recruiting
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021
- Recruiting
Shantou Center Hospital
Shantou, 515031
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300000
- Recruiting
Tianjin Cancer hospital Airport hospital
Tianjin, 300300
- Recruiting
Xinjiang Medical University Cancer Hospital
Ürümqi, 830011
- Recruiting
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, 710004
- Recruiting
Shanxi Provincial People's Hospital
Xi'an, 710068
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441106
Italy17 sites, 17 recruiting
- Recruiting
Asst Papa Giovanni XXIII
Bergamo, Lombardy, 24127
- Recruiting
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138
- Recruiting
Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia Medic
Bolzano, Trentino-Alto Adige, 39100
- Recruiting
A.O. S. Anna e San Sebastiano
Caserta, Campania, 81100
- Recruiting
Ospedale Civile - Livorno
Livorno, Tuscany, 57124
- Recruiting
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, 47014
- Recruiting
Ospedale San Raffaele
Milan, Lombardy, 20132
- Recruiting
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133
- Recruiting
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily, 95045
- Recruiting
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, 41100
- Recruiting
A.O. Universitaria Federico II Di Napoli
Naples, Campania, 80131
- Recruiting
U.O.C. Oncologia Medica Senologica
Naples, Campania, 80131
- Recruiting
University of Eastern Piedmont - Maggiore della Carità University Hospital
Novara, Umbria, 28100
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
- Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
- Recruiting
A.O. Santa Maria Terni
Terni, Umbria, 05100
- Recruiting
Az. Osp. G. Panico
Tricase (LE), Apulia, 73039
Germany15 sites, 15 recruiting
- Recruiting
St. Elisabeth Krankenhaus Köln GmbH
Cologne, 50935
- Recruiting
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
- Recruiting
Universitätsklinikum Essen
Essen, 45122
- Recruiting
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, 45136
- Recruiting
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, 20357
- Recruiting
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, 30625
- Recruiting
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120
- Recruiting
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, 56068
- Recruiting
Dres. Andreas Köhler und Roswitha Fuchs
Langen, 63225
- Recruiting
Universitätsklinikum Münster
Münster, 48149
- Recruiting
Klinikum Ernst von Bergmann
Potsdam, 14467
- Recruiting
Caritas-Krankenhaus St. Josef
Regensburg, 93053
- Recruiting
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, 66113
- Recruiting
Universitätsklinik Tübingen
Tübingen, 72076
- Recruiting
Universitätsklinikum Ulm Am Michelsberg
Ulm, 89075
Spain15 sites, 15 recruiting
- Recruiting
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
- Recruiting
Hospital de Basurto
Bilbao, Vizcaya, 48013
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
- Recruiting
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
- Recruiting
Hospital Universitario de la Princesa
Madrid, 28006
- Recruiting
IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica
Madrid, 28007
- Recruiting
Hospital General Univ. Gregorio Maranon
Madrid, 28009
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
- Recruiting
Hospital Universitario Clínico San Carlos
Madrid, 28040
- Recruiting
Hospital Universitario 12 De Octubre
Madrid, 28041
- Recruiting
Hospital Clinico Universitario Virgen de la Victoria;Servicio de Oncologia
Málaga, 29011
- Recruiting
Hospital de Navarra
Pamplona/iruña, Navarre, 31008
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
- Recruiting
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia, 46009
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Brazil13 sites, 13 recruiting
- Recruiting
Centro de Oncologia de Alfenas
Alfenas, Minas Gerais, 37130-087
- Recruiting
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
- Recruiting
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-232
- Recruiting
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070
- Recruiting
Hospital do Câncer de Londrina
Londrina, Paraná, 86015-520
- Recruiting
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
- Recruiting
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000
- Recruiting
Instituto Nacional de Cancer - INCa
Rio de Janeiro, 20560-120
- Recruiting
Obras Sociais Irma Dulce - Osid
Salvador, Estado de Bahia, 40415-006
- Recruiting
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
- Recruiting
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-001
- Recruiting
Vencer Oncoclínica - Centro de Pesquisa do Piauí
Teresina, Piauí, 64049-200
- Recruiting
Hospital Santa Rita de Cassia Vitoria
Vitória, Espírito Santo, 29043-260
Canada12 sites, 12 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta, T2N 4C2
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
- Recruiting
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, H4J 1C5
- Recruiting
The Ottawa Hospital Cancer Center
Ottawa, Ontario, K1H 8L6
- Recruiting
Unité de Recherche Clinique du CISSS de Laurentides
Saint-Jérôme, Quebec, J7Z 2V4
- Recruiting
Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
- Recruiting
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
France12 sites, 12 recruiting
- Recruiting
ICO Paul Papin
Angers, 49055
- Recruiting
Centre Oscar Lambret
Lille, 59020
- Recruiting
Centre Cancerologie Grand Montpellier
Montpellier, 34070
- Recruiting
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
Paris, 75005
- Recruiting
Centre CARIO - HPCA
Plérin, 22190
- Recruiting
Chu La Miletrie
Poitiers, 86021
- Recruiting
Centre Eugene Marquis
Rennes, 35042
- Recruiting
Centre Henri Becquerel
Rouen, 76038
- Recruiting
HOPITAL RENE HUGUENIN- Institut Curie
Saint-Cloud, 92211
- Recruiting
Ico Rene Gauducheau
Saint-Herblain, 44805
- Recruiting
Institut Universitaire de Cancer de Toulouse Oncopole
Toulouse, 31100
- Recruiting
Gustave Roussy
Villejuif, 94805
Japan10 sites, 10 recruiting
- Recruiting
Aichi Cancer Center
Aichi, 464-8681
- Recruiting
Chiba Cancer Center
Chiba, 260-8717
- Recruiting
Fukushima Medical University Hospital
Fukushima, 960-1295
- Recruiting
Hiroshima University Hospital
Hiroshima, 734-8551
- Recruiting
Hokkaido University Hospital
Hokkaido, 060-8648
- Recruiting
Kanagawa Cancer Center
Kanagawa, 241-8515
- Recruiting
Tokai University Hospital
Kanagawa, 259-1193
- Recruiting
Okayama University Hospital
Okayama, 700-8558
- Recruiting
Saitama Medical University International Medical Center
Saitama, 350-1298
- Recruiting
The Cancer Inst. Hosp. of JFCR
Tokyo, 135-8550
Poland10 sites, 9 recruiting
- Recruiting
Instytut "Centrum Zdrowia Matki Polki"
?ód?, 93-338
- Recruiting
Bialostockie Centrum Onkologii
Bialystok, 15-027
- Recruiting
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, 62-500
- Recruiting
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, 75-581
- Withdrawn
Szpital Miejski Specjalistyczny Narutowicza
Krakow, 31-202
- Recruiting
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, 20-090
- Recruiting
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Późna, 61-866
- Recruiting
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
Rzeszów, 35-021
- Recruiting
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, 02-781
- Recruiting
Dolno?l?skie Centrum Onkologii
Wroc?aw, 53-413
South Korea9 sites, 9 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
- Recruiting
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, 31151
- Recruiting
National Cancer Center
Goyang-si, 10408
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 463-707
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Gangnam Severance Hospital
Seoul, 06273
- Recruiting
Samsung Medical Center
Seoul, 06351
United Kingdom9 sites, 9 recruiting
- Recruiting
Blackpool Victoria Hospital
Blackpool, FY3 8NR
- Recruiting
Colchester General Hospital
Colchester, Essex, CO4 5JL
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
- Recruiting
Princess Alexandra Hospital
Harlow, CM20 1QX
- Recruiting
St Bartholomew's Hospital
London, EC1M 6BQ
- Recruiting
Royal Free Hospital
London, NW3 2QG
- Recruiting
Mount Vernon & Watford Hospital Trust
Northwood, HA6 2RN
- Recruiting
Churchill Hospital - Oxford Cancer & Haematology Centre
Oxford, OX3 7LE
- Recruiting
Weston Park Hospital
Sheffield, S10 2SJ
Mexico8 sites, 8 recruiting
- Recruiting
Centro Estatal de Cancerologia de Chihuahua
Chihuahua City, 31000
- Recruiting
Centro de Investigacion y Tratamiento Integral del Cancer: CITI Cancer Oaxaca S.A de C.V.
Ciudad de Huajuapan de León, Oaxaca, 69007
- Recruiting
Iem-Fucam
D.F., 04980
- Recruiting
Instituto Nacional De Cancerologia
Distrito Federal, Mexico CITY (federal District), 14000
- Recruiting
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280
- Recruiting
Hospital General de Mexico
MexicoCiudad de México, Nuevo León, 6726
- Recruiting
Hospital Zambrano Hellion TecSalud
Monterrey, Nuevo León
- Recruiting
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, 68020
Taiwan6 sites, 6 recruiting
- Recruiting
Chia-Yi Christian Hospital
Chiayi City, 600566
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
- Recruiting
National Cheng Kung Uni Hospital
Tainan, 704
- Recruiting
National Taiwan Uni Hospital
Taipei, 100
- Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112019
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
Ankara, 06200
- Recruiting
Ankara City Hospital
Ankara, 06800
- Recruiting
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147
- Recruiting
Ba?c?lar Medipol Mega Üniversite Hastanesi
Istanbul, 34214
- Recruiting
Izmir Ataturk Training and Research Hospital
Izmir, 35360
- Recruiting
Mersin City Education and Research Hospital
Mersin, 33240
Argentina5 sites, 5 recruiting
- Recruiting
Centro Oncologico Korben
Caba, C1426AGE
- Recruiting
Centro Médico Fleischer
Capital Federal, C1414
- Recruiting
Hospital Privado Centro Medico de Cordoba
Córdoba, 5016
- Recruiting
Instituto de Oncologia de Rosario
Rosario, S2013KZE
- Recruiting
Centro Oncológico de Excelencia
San Juan, J5400
Australia5 sites, 5 recruiting
- Recruiting
Blacktown Hospital
Blacktown, New South Wales, 2148
- Recruiting
Monash Health
Clayton, Victoria, 3168
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
- Recruiting
Maroondah hospital;Oncology clinical trials
Ringwood, Victoria, 3135
- Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Switzerland4 sites, 4 recruiting
- Recruiting
Kantonsspital Baden Zentrum für Onkologie und Hämatologie
Baden, 5404
- Recruiting
Universitätsspital Basel
Basel, 4031
- Recruiting
CHUV
Lausanne, 1011
- Recruiting
Luzerner Kantonsspital
Lucerne, 6004
South Africa3 sites, 2 recruiting
- Withdrawn
Linksfield Oncology Inc.
Johannesburg, 2192
- Recruiting
Abraham Oncology
Richards Bay, 3900
- Recruiting
Wits Clinical Research
Soweto, 2013
Puerto Rico1 site, 1 recruiting
- Recruiting
PanOncology Trials
San Juan, 00935
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
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).
- Conditions
- Breast Cancer
- Being tested
- Inavolisib, Placebo, CDK4/6i, Letrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InavolisibDrug
Also called GDC-0077, Itovebi
Participants will receive oral inavolisib once daily (QD).
PlaceboDrug
Participants will receive oral placebo QD.
CDK4/6iDrug
Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
LetrozoleDrug
Participants will receive oral letrozole QD.
| Study group | Role | What they receive |
|---|---|---|
| Inavolisib + Letrozole + CDK4/6i | Experimental | Participants will receive inavolisib, letrozole and CDK4/6i. Receives: Drug: Inavolisib; Drug: CDK4/6i; Drug: Letrozole |
| Placebo + Letrozole + CDK4/6i | Placebo comparator | Participants will receive placebo, letrozole and CDK4/6i. Receives: Drug: Placebo; Drug: CDK4/6i; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
Secondary outcomes (13)
Overall Survival (OS)
Measured: From randomization to death from any cause (up to 7 years)
Investigator-assessed Objective Response Rate (ORR)
Measured: Up to 7 years
Investigator-assessed Duration of Response (DOR)
Measured: From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
Investigator-assessed Clinical Benefit Rate (CBR)
Measured: Up to 7 years
Time to Confirmed Deterioration (TTCD) in Pain
Measured: From baseline until end of follow-up (up to 7 years)
TTCD in Physical Function
Measured: From baseline until end of follow-up (up to 7 years)
TTCD in Role Function
Measured: From baseline until end of follow-up (up to 7 years)
TTCD in Global Health Status
Measured: From baseline until end of follow-up (up to 7 years)
Percentage of Participants with Adverse Events
Measured: From baseline until end of follow-up (up to 7 years)
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Measured: Up to 7 years
Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G)
Measured: Up to 7 years
Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE
Measured: Baseline up to 7 years
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Measured: Baseline up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start9 Apr 2025
- Primary completion31 Jan 2032 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790693
- Sponsor's protocol ID
- WO45654
- Other IDs
- 2024-516162-11-00
- Acronym
- INAVO123
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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