A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT04191499
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
325 participants
INTERVENTIONAL
2020-01-29
2027-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Inavolisib + Palbociclib + Fulvestrant
Participants will receive inavolisib, palbociclib, and fulvestrant.
Inavolisib
Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.
Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
Placebo + Palbociclib + Fulvestrant
Participants will receive placebo, palbociclib, and fulvestrant. Participants randomized to the placebo arm who are still deriving benefit from the study treatment will be given an optional opportunity to crossover to the inavolisib arm.
Placebo
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
Interventions
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Inavolisib
Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.
Placebo
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 2 weeks after the final dose of study treatment
* Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Beverly Hills Cancer Center
Beverly Hills, California, United States
Massachusetts General Hospital.
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology - Central South
Austin, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, , Argentina
Hosp Provincial D. Centenarios
Rosario, , Argentina
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Western Health
Fitzroy, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
UZ Leuven Gasthuisberg
Leuven, , Belgium
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, Canada
London Regional Cancer Program, London Health Sciences Centre, Baines Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Hopital du Saint Sacrement
Québec, Quebec, Canada
Beijing Cancer Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, , China
Fujian Medical University Union Hospital
Fujian, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Hebei Medical University Fourth Hospital
Shijiazhuang, , China
Tianjin Cancer Hospital
Tianjin, , China
Hubei Cancer Hospital
Wuhan, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
Henan Cancer Hospital
Zhengzhou, , China
Vejle Sygehus
Vejle, , Denmark
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
Clermont-Ferrand, , France
Centre Georges Francois Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Hopital Prive Jean Mermoz
Lyon, , France
Institut régional du Cancer Montpellier
Montpellier, , France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, , France
Israel-Georgian Medical Research Clinic Healthycore
Tbilisi, , Georgia
Tbilisi Oncology Dispensary
Tbilisi, , Georgia
Ambulantes Tumorzentrum Spandau
Berlin, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, , Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Trier, , Germany
Universitätsfrauenklinik Ulm
Ulm, , Germany
Anticancer Hospital Ag. Savas
Athens, , Greece
Univ General Hosp Heraklion
Heraklion, , Greece
Euromedical General Clinic of Thessaloniki
Thessaloniki, , Greece
European Interbalkan Medical Center
Thessaloniki, , Greece
Queen Mary Hospital
Hong Kong, , Hong Kong
Orszagos Onkologiai Intezet
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, , Hungary
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, Italy
Az. Osp. Spedali Civili
Brescia, Lombardy, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Tuscany, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padua, Veneto, Italy
National Cancer Institute IKN
Putrajaya, Federal Territory of Putrajaya, Malaysia
Hospital Sultan Ismail
Johor Bahru, Johor, Malaysia
Sarawak General Hospital
Sarawak, Sarawak, Malaysia
Palmerston North Hospital
Palmerston North, , New Zealand
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, , Poland
Centro Clinico Champalimaud
Lisbon, , Portugal
IPO do Porto
Porto, , Portugal
Moscow Clinical Scientific Center
Moscow, Moscow Oblast, Russia
Blokhin Cancer Research Center
Moscow, Moscow Oblast, Russia
LLC Medscan
Moskva, Moscow Oblast, Russia
Clinical Hospital Lapino (LLC Haven)
Yudino, Moscow Oblast, Russia
Medical Clinic "AB Medical group"
Saint Petersburg, Sankt-Peterburg, Russia
Volgograd Regional Clinical Oncology Dispensary
Volgograd, , Russia
Regional Clinical Oncology Hospital
Yaroslavl, , Russia
National University Hospital
Singapore, , Singapore
National Cancer Centre
Singapore, , Singapore
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Medical Center
Daegu, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , 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
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital del Mar
Barcelona, , Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , Spain
Insituto Catalán de Oncologia (ICO)
Barcelona, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
Jaén, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Clinica Universidad de Navarra-Madrid
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Instituto Valenciano Oncologia
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Kaohsiung Medical Uni Chung-Ho Hospital
Kaohsiung City, , Taiwan
Veterans General Hospital
Taipei, , Taiwan
National Taiwan Uni Hospital
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Tri-Service General Hospital, Division of General Surgery
Taipei, , Taiwan
Ramathibodi Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Chulabhorn Hospital
Lak Si, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Adana Baskent University Hospital
Adana, , Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Ege University Medical Faculty
Bornova, ?zm?r, , Turkey (Türkiye)
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, , Turkey (Türkiye)
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
Kharkiv, Kharkiv Governorate, Ukraine
Municipal Institution SubCarpathian Clinical Oncological Centre
Ivano-Frankivsk, KIEV Governorate, Ukraine
Uzhhorod Central City Clinical Hospital
Uzhhorod, KIEV Governorate, Ukraine
City Clinical Hospital #4
Dnipropetrovsk, , Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
Kryvyi Rih, , Ukraine
Kyiv City Clinical Oncological Center
Kyiv, , Ukraine
Royal Marsden Hospital - Fulham
London, , United Kingdom
Mount Vernon Hospital
Northwood, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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References
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Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31.
Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-002455-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505812-39-00
Identifier Type: CTIS
Identifier Source: secondary_id
WO41554
Identifier Type: -
Identifier Source: org_study_id
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