A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
3 other identifiers
interventional
992
29 countries
250
Brief Summary
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2020
Longer than P75 for phase_3
250 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
September 11, 2020
CompletedStudy Start
First participant enrolled
October 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2028
ExpectedFebruary 20, 2026
February 1, 2026
5.3 years
September 8, 2020
February 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months)
Secondary Outcomes (13)
Overall Survival
From randomization to death from any cause (up to 78 months)
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
From randomization until disease progression or death (up to 78 months)
Duration of Response, as Determined by the Investigator According to RECIST v1.1
From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months)
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
From randomization until disease progression or death (up to 78 months)
Time to Confirmed Deterioration in Pain Level, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire
From Baseline until treatment discontinuation (up to 78 months)
- +8 more secondary outcomes
Study Arms (2)
Giredestrant + Letrozole-matched Placebo + Palbociclib
EXPERIMENTALLetrozole + Giredestrant-matched Placebo + Palbociclib
ACTIVE COMPARATORInterventions
Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.
Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Eligibility Criteria
You may qualify if:
- For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
- Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- Documented ER-positive tumor and HER2-negative tumor, assessed locally
- Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
- No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
- Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
- Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
- Eastern Cooperative Oncology Group Performance Status 0-1
- Adequate organ function
You may not qualify if:
- Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
- Prior treatment with a selective estrogen receptor degrader (SERD)
- Treatment with any investigational therapy within 28 days prior to study treatment
- Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (256)
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Kaiser Permanente - San Leandro Medical Center
San Leandro, California, 94577, United States
Stanford Univ Medical Center
Stanford, California, 94305, United States
Kaiser Permanente - Walnut Creek
Walnut Creek, California, 94596, United States
University of Colorado
Aurora, Colorado, 80045-2517, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers, Florida, 33901, United States
Memorial Regional Cancer Ctr
Hollywood, Florida, 33021, United States
University of Miami
Miami, Florida, 33136, United States
SCRI Florida Cancer Specialists North
St. Petersburg, Florida, 33705, United States
SCRI Florida Cancer Specialists PAN
Tallahassee, Florida, 32308, United States
Kaiser Permanente - Moanalua Medical Center
Honolulu, Hawaii, 96819-1469, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Maryland Oncology Hematology
Silver Spring, Maryland, 20902, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
HCA Midwest Division
Kansas City, Missouri, 64132, United States
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816, United States
Memorial Sloan Kettering Cancer Center at Bergen
Montvale, New Jersey, 07645, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
MSKCC @ Commack
Commack, New York, 11725, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Providence Portland Medical Ctr
Portland, Oregon, 97213, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29414, United States
West Cancer Center
Germantown, Tennessee, 38138, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology - DFW
Dallas, Texas, 75246, United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, 76104, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE, Argentina
Hospital de Onc Angel Roffo
Buenos Aires, 1425, Argentina
Organización medica de Investi
Cap Fed, 1015, Argentina
Hospital Britanico
Ciudad Autonoma Bs As, C1280AEB, Argentina
Hospital Provincial del Centenario
Rosario, 2000, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
CEMER Centro Medico de Enfermedades Respiratorias
Vicente López, B1602DQD, Argentina
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Peter MacCallum Cancer Centre-East Melbourne
Melbourne, Victoria, 3000, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Fiona Stanley Hospital - Medical Oncology
Murdoch, Western Australia, 6150, Australia
Uniklinikum Salzburg, LKH
Salzburg, 5020, Austria
A.Ö. LHK
Steyr, 4400, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-000, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo, São Paulo, 01323-900, Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, T2N 5G2, Canada
BC Cancer ? Surrey
Surrey, British Columbia, V3V 1Z2, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
William Osler Health System Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9, Canada
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8, Canada
Anyang Tumor Hosptial
Anyang, 455000, China
Affiliated Hospital of Hebei University
Baoding, 071000, China
Beijing Cancer Hospital
Beijing, 100142, China
the First Affiliated Hospital of Bengbu Medical College
Bengbu, 233000, China
The First Hospital of Jilin University
Changchun, 130021, China
Hunan Cancer Hospital
Changsha, 410013, China
Fujian Medical University Union Hospital
Fujian, 350001, China
Sun Yat-sen Memorial Hospital
Guangzhou, 510000, China
Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, 310016, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shandong Cancer Hospital
Jinan, 250117, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
Shengjing Hospital of China Medical University
Shenyang, 110004, China
Liaoning cancer Hospital & Institute
Shenyang, 110042, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061, China
Herlev Hospital
Herlev, 2730, Denmark
Sjællands Universitetshospital, Næstved
Næstved, 4700, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, 5000, Denmark
ICO Paul Papin
Angers, 49055, France
Centre Hospitalier de La Cote Basque
Bayonne, 64109, France
Chd de Vendee
La Roche-sur-Yon, 85925, France
Institut régional du Cancer Montpellier
Montpellier, 34298, France
Chu La Miletrie
Poitiers, 86021, France
Institut Jean Godinot
Reims, 51056, France
Centre Eugene Marquis
Rennes, 35042, France
ICL
Saint-Priest-en-Jarez, 42271, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Ambulantes Tumorzentrum Spandau
Berlin, 13581, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, 49124, Germany
Dres.Andreas Ammon und Dirk Meyer
Göttingen, 37073, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Facharztzentrum Eppendorf, Studien GbR
Hamburg, 20249, Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, 30625, Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120, Germany
Praxis Köppler, Heymann, Weide, Thomalla
Koblenz, 56068, Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen, 63225, Germany
St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
Leipzig, 04277, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, 80336, Germany
MVZ für Hämatologie und Onkologie Ravensburg GmBH
Ravensburg, 88212, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Trier, 54290, Germany
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen
Troisdorf, 53840, Germany
Universitätsklinik Tübingen
Tübingen, 72076, Germany
Anticancer Hospital Ag Savas
Athens, 115 22, Greece
Anticancer Hospital Ag. Savas
Athens, 115 22, Greece
Euromedical General Clinic of Thessaloniki
Thessaloniki, 546450, Greece
European Interbalkan Medical Center
Thessaloniki, 570 01, Greece
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Honvédelmi Minisztérium Állami Egészségügyi Központ;Onkológiai Osztály
Budapest, 1062, Hungary
Budapesti Uzsoki Utcai Kórház
Budapest, 1145, Hungary
Davidof Center - Rabin Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 52620-00, Israel
Tel Aviv Sourasky Medical Ctr
Tel Aviv, 6423906, Israel
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, 47014, Italy
IRCCS Istituto Regina Elena (IFO)
Rome, Lazio, 00144, Italy
Az. Osp. Spedali Civili
Brescia, Lombardy, 25123, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
Asst Di Monza
Monza, Lombardy, 20900, Italy
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily, 95045, Italy
Fondazione del Piemonte per l?Oncologia (IRCCS)
Candiolo, Trentino-Alto Adige, 10060, Italy
Ospedale Civile - Livorno
Livorno, Tuscany, 57124, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, 37024, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padua, Veneto, 35128, Italy
Azienda ULSS 8 Berica
Vicenza, Veneto, 36100, Italy
Nagoya University Hospital
Aichi, 466-8560, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
National Cancer Center Hospital East
Chiba, 277-8577, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, 003-0804, Japan
Hyogo Cancer Center
Hyōgo, 673-0021, Japan
University of Tsukuba Hospital
Ibaraki, 305-8576, Japan
Sagara Hospital
Kagoshima, 892-0833, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Fukushima Medical University Hospital
Miyagi, 960-1295, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Naha-nishi Clinic
Okinawa, 901-0154, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Showa Medical University Hospital
Tokyo, 142-8666, Japan
Health Pharma Professional Research
CD Mexico, Mexico CITY (federal District), 03810, Mexico
Centro de Atencion Oncologica Viva S de RL de CV
Mexico City, Mexico CITY (federal District), 06760, Mexico
Filios Alta Medicina
Monterrey, Nuevo León, 64460, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, 68020, Mexico
Oncologico Potosino
San Luis Potosí City, San Luis Potosí, 78209, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Morelia, 58260, Mexico
Sociedad de Metabolismo y Corazón (SOMECO)
Veracruz, 91900, Mexico
Auckland City Hospital
Auckland, 1023, New Zealand
Oncosalud Sac
Lima, 41, Peru
Instituto Peruano de Oncología y Radioterapia
Lima, Lima 27, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34, Peru
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
Trujillo, 13014, Peru
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214, Poland
Szpital Morski im. PCK
Gdynia, 81-519, Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, 02-781, Poland
IPO de Coimbra
Coimbra, 3000-075, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar Lisboa Norte
Lisbon, Portugal
IPO do Porto
Porto, 4200-072, Portugal
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva, Moscow Oblast, 111123, Russia
Podolsk City Clinical Hospital
Podolsk, Moscow Oblast, 142100, Russia
Respublikanskiy Onkologicheskiy Dispanser
Saransk, Respublika Mordoviya, 430032, Russia
Ryazan Regional clinical oncology dispensary
Ryazan, Ryazan Oblast, 390011, Russia
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Chelyabinsk region oncology dispensary
Chelyabinsk, 454087, Russia
Multidisciplinary clinic Reaviz
Samara, 443011, Russia
Regional Clinical Oncology Hospital
Yaroslavl, 150040, Russia
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Kyungpook National University Medical Center
Daegu, 41944, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 8308, South Korea
Ulsan University Hosiptal
Ulsan, 44033, South Korea
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 8208, Spain
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, 20080, Spain
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, 15006, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, 08028, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Centro Oncologico MD Anderson Internacional
Madrid, 28033, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
HM Sanchinarro ? CIOCC
Madrid, 28050, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
China Medical University Hospital
Taichung, 404, Taiwan
National Cheng Kung Uni Hospital
Tainan, 704, Taiwan
Veterans General Hospital
Taipei, 00112, Taiwan
National Taiwan Uni Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Chang Gung Memorial Hosipital at Linkou
Taoyuan Hsien, 333, Taiwan
Chulalongkorn Hospital, Faculty of Medicine
Bangkok, 10330, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hosp
Chang Mai, 50200, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Hacettepe Uni Medical Faculty Hospital
Ankara, 06100, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06490, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030, Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, 34214, Turkey (Türkiye)
Katip Celebi University Ataturk Training and Research Hospital
Izmir, 35360, Turkey (Türkiye)
Kocaeli University Faculty of Medicine
İzmit, 31380, Turkey (Türkiye)
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, 44280, Turkey (Türkiye)
19 Mayis University Medical Faculty
Samsun, 55139, Turkey (Türkiye)
Municipal Institution City Clinical Hospital #4 of Dnipro City Council
Dnipropetrovsk, Katerynoslav Governorate, 49102, Ukraine
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
Kharkiv, Kharkiv Governorate, 61018, Ukraine
Ivano-Frankivsk Regional Oncology Center
Ivano-Frankivsk, 76018, Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
Kryvyi Rih, 50048, Ukraine
Sumy Regional Clinical Onc Ctr
Sumy, 40005, Ukraine
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
University College London Hospital
London, NW1 - 2PG, United Kingdom
Royal Free Hospital
London, NW3 2QS, United Kingdom
Guys & St Thomas Hospital
London, SE1 9RT, United Kingdom
Maidstone Hospital
Maidstone, ME16 0FS, United Kingdom
Peterborough City Hospital
Peterborough, PE3 9GZ, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Royal Marsden Hosp NHS Fnd
Sutton, SM2 5PT, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LQ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2020
First Posted
September 11, 2020
Study Start
October 9, 2020
Primary Completion
January 30, 2026
Study Completion (Estimated)
March 25, 2028
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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