A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Eli Lilly and Company
Sponsor
Eli Lilly and Company
Information Provided by (Responsible Party)
Eli Lilly and Company
Clinicaltrials.gov Identifier
NCT07174336
Other Study ID Numbers:
27726
First Submitted
September 11, 2025
First Posted
September 14, 2025
Last Update Posted
April 28, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Breast NeoplasmsNeoplasm Metastasis
Drug: LY4064809Drug: LY4064809Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment920 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
Study Start DateDecember 21, 2025
Actual Primary Completion Date3yrs 7h from now
Actual Study Completion Date7yrs 7h from now

Groups and Cohorts

Group/CohortIntervention/Treatment
LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 1)
LY4064809 given orally in one of two doses in combination with investigator's choice of CDK4/6 inhibitor given orally and ET given orally or intramuscularly
Drug: LY4064809
Administered orally
LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)
LY4064809 given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly
Drug: LY4064809
Administered orally
Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)
Placebo given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly
Drug: Placebo
Administered orally

Outcome Measures

Primary Outcome Measures
  1. (Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)
    As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
  2. (Part 2): Progression-Free Survival
    Investigator-assessed
Secondary Outcome Measures
  1. (Part 1): Disease Control Rate (DCR)
    per RECIST v1.1
  2. (Part 1): Time to Response (TTR)
    per RECIST v1.1
  3. (Parts 1 and 2): Duration of Response (DOR)
    per RECIST v1.1
  4. (Part 1): PFS
    per RECIST v1.1
  5. (Parts 1 and 2): Overall Survival (OS)
  6. (Part 1): Best Overall Response (BOR)
  7. (Parts 1 and 2): Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD Lasting Greater than or Equal to Six Months
    per RECIST v1.1
  8. (Parts 1 and 2): PK: Average Plasma Concentrations of LY4064809
  9. (Part 2): Progression-Free Survival after Subsequent Line of Treatment (PFS2)
    Investigator-assessed
  10. (Part 2): Progression-Free Survival (PFS)
    By BICR
  11. (Part 2): Objective Response Rate (ORR)
    By investigator and blinded independent central review (BICR)
  12. (Part 2): Time to Chemotherapy (TTC)
  13. (Part 2): Chemotherapy-Free Survival
  14. (Part 2): Change in Overall Health-related Quality of Life (HRQoL) as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Subscale
    The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale (two items). Response options range from 1) "very poor" to 7) "excellent." Score is linearly transformed to the range 0 - 100. Higher score represents better overall HRQoL.
  15. (Part 2): Change in Physical Function as measured by the EORTC QLQ-C30 Physical Functioning Subscale
    The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Physical function is measured by the EORTC QLQ-C30 Physical Functioning subscale (five items). Response options range from 1) "not at all" to 4) "very much." Score is linearly transformed to the range 0 - 100. Higher score represents better overall physical function.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.
If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.
Have histologically or cytologically confirmed breast cancer, defined as individuals with
locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and
hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally
HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines
Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.
Have measurable disease or non-measurable, evaluable bone disease
Part 1:
Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.
Up to 1 of these prior systemic treatments may contain chemotherapy
Part 2:
Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.
Individuals who are eligible are either
Population 1 (P1): Endocrine sensitive
newly diagnosed with advanced breast cancer (de novo)
relapsed with documented evidence of progression greater than (\>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or
Population 2 (P2): Endocrine resistant
relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor.
if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be \>12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy.
Exclusion Criteria
Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter \[mmol/L\]), or requiring insulin.
Have inflammatory or metaplastic breast cancer.
History of leptomeningeal disease or carcinomatous meningitis.
Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.
Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.
Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \[mg\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment.

Contacts and Locations

Sponsors and CollaboratorsEli Lilly and Company
Locations
Alaska Oncology and Hematology | Anchorage Alaska, United States, 99508Ironwood Cancer & Research Centers | Chandler Arizona, United States, 85224Mayo Clinic in Arizona - Phoenix | Phoenix Arizona, United States, 85054The University of Arizona Cancer Center - North Campus | Tucson Arizona, United States, 85719Genesis Cancer and Blood Institute | Hot Springs Arkansas, United States, 71913Highlands Oncology Group | Springdale Arkansas, United States, 72762City of Hope | Duarte California, United States, 91010Marin Cancer Care | Greenbrae California, United States, 94904Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine | Irvine California, United States, 92612City of Hope Orange County Lennar Foundation Cancer Center | Irvine California, United States, 92618Moores Cancer Center | La Jolla California, United States, 92093USC/Norris Comprehensive Cancer Center | Los Angeles California, United States, 90033Hoag Memorial Hospital Presbyterian | Newport Beach California, United States, 92663Kaiser Permanente Oakland | Oakland California, United States, 94611Profound Research LLC | Oceanside California, United States, 92056University of California, Irvine (UCI) Health - UC Irvine Medical Center | Orange California, United States, 92868Desert Regional Medical Center | Palm Springs California, United States, 92262Stanford Cancer Center | Palo Alto California, United States, 94304Kaiser Permanente | Roseville California, United States, 95661Kaiser Permanente | San Francisco California, United States, 94115UCSF Medical Center at Mission Bay | San Francisco California, United States, 94158Kaiser Permanente | Santa Clara California, United States, 95051UCLA Hematology/Oncology - Parkside | Santa Monica California, United States, 90404Providence Medical Foundation | Santa Rosa California, United States, 95403Kaiser Permanente | Vallejo California, United States, 94589Kaiser Permanente Walnut Creek | Walnut Creek California, United States, 94596Cancer Centers of Colorado St. Mary's Regional Hospital | Grand Junction Colorado, United States, 81501Banner MD Anderson Cancer Center at North Colorado Medical Center | Greeley Colorado, United States, 80631Banner MD Anderson Cancer Center at McKee Medical Center | Loveland Colorado, United States, 80538MedStar Washington Hospital Center | Washington D.C. District of Columbia, United States, 20010AdventHealth Altamonte Springs | Altamonte Springs Florida, United States, 32701Clermont Oncology Center | Clermont Florida, United States, 34711Florida Oncology & Hematology | Fort Myers Florida, United States, 33912Mayo Clinic in Florida | Jacksonville Florida, United States, 32224Mid Florida Hematology and Oncology Center | Orange City Florida, United States, 32763Central Georgia Cancer Care | Macon Georgia, United States, 31210City of Hope National Medical Center, Atlanta Cancer Center | Newnan Georgia, United States, 30265Summit Cancer Care, PC | Savannah Georgia, United States, 31405Kaiser Permanente Moanalua Medical Center | Honolulu Hawaii, United States, 96819City of Hope, Chicago | Chicago Illinois, United States, 60611Northwestern Memorial Hospital | Chicago Illinois, United States, 60611University of Illinois at Chicago | Chicago Illinois, United States, 60612Accellacare of Duly | Lisle Illinois, United States, 60532Simmons Cancer Institute at SIU | Springfield Illinois, United States, 62702Indiana University Health University Hospital | Indianapolis Indiana, United States, 46202Deaconess Chancellor Center for Oncology | Newburgh Indiana, United States, 47630University of Iowa | Iowa City Iowa, United States, 52242Saint Elizabeth Medical Center Edgewood | Edgewood Kentucky, United States, 41017Our Lady of the Lake RMC | Baton Rouge Louisiana, United States, 70808New England Cancer Specialists | Westbrook Maine, United States, 04092American Oncology Partners, PA | Bethesda Maryland, United States, 20817James M Stockman Cancer Institute | Frederick Maryland, United States, 21702Mass General Cancer Center | Boston Massachusetts, United States, 02114Dana-Farber Cancer Institute | Boston Massachusetts, United States, 02215Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center | Milford Massachusetts, United States, 01757Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital | South Weymouth Massachusetts, United States, 02190Profound Research LLC | Sterling Heights Michigan, United States, 48314Mayo Clinic in Rochester, Minnesota | Rochester Minnesota, United States, 55905North Mississippi Hematology and Oncology Associates | Tupelo Mississippi, United States, 38801Saint Luke's Cancer Institute | Kansas City Missouri, United States, 64111Oncology Hematology Associates | Springfield Missouri, United States, 65807Dartmouth-Hitchcock Medical Center | Lebanon New Hampshire, United States, 03756Jefferson Health - Cherry Hill | Cherry Hill New Jersey, United States, 08002Sidney Kimmel Cancer Center - Washington Township | Sewell New Jersey, United States, 08080Atlantic Health System Overlook Medical Center | Summit New Jersey, United States, 07901Memorial Sloan Kettering Cancer Center | New York New York, United States, 10065Messino Cancer Centers | Asheville North Carolina, United States, 28806WakeMed Cancer Care - Waverly Hematology & Medical Oncology | Cary North Carolina, United States, 27518University of North Carolina Medical Center | Chapel Hill North Carolina, United States, 27599Carolina Cancer Research Center | Wilson North Carolina, United States, 27893Cleveland Clinic Akron General | Akron Ohio, United States, 44302Gabrail Cancer Center | Canton Ohio, United States, 44718Fairview Hospital | Cleveland Ohio, United States, 44111The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T | Columbus Ohio, United States, 43210Cleveland Clinic - Hillcrest Hospital | Mayfield Heights Ohio, United States, 44124Good Samaritan Regional Medical Center | Corvallis Oregon, United States, 97330Oncology Associates of Oregon | Eugene Oregon, United States, 97401Oregon Health and Science University | Portland Oregon, United States, 97239St. Luke's University Health Network | Bethlehem Pennsylvania, United States, 18015University of Pennsylvania Hospital | Philadelphia Pennsylvania, United States, 19104Thomas Jefferson University - Clinical Research Institute | Philadelphia Pennsylvania, United States, 19107Jefferson Hospital Northeast | Philadelphia Pennsylvania, United States, 19114Asplundh Cancer Pavilion | Willow Grove Pennsylvania, United States, 19090Medical University of South Carolina | Charleston South Carolina, United States, 29425Sarah Cannon Research Institute SCRI | Nashville Tennessee, United States, 37203Nashville General Hospital | Nashville Tennessee, United States, 37208Hendrick Medical Center | Abilene Texas, United States, 79601World Research Link | Baytown Texas, United States, 77521Parkland Health and Hospital System | Dallas Texas, United States, 75235USO - Texas Oncology | Dallas Texas, United States, 75246UT Southwestern Medical Center | Dallas Texas, United States, 75390Texas Oncology - West Texas | El Paso Texas, United States, 79902The University of Texas MD Anderson Cancer Center | Houston Texas, United States, 77030-4009Houston Methodist Hospital | Houston Texas, United States, 77030Oncology Consultants P.A. | Houston Texas, United States, 77030Nova Oncology | McAllen Texas, United States, 78504Texas Oncology - San Antonio Medical Center | San Antonio Texas, United States, 78240US Oncology Research Network | The Woodlands Texas, United States, 77380Tranquility Research | Webster Texas, United States, 77598Utah Cancer Specialists | Salt Lake City Utah, United States, 84106Virginia Cancer Specialists | Fairfax Virginia, United States, 22031Swedish Cancer Institute - Edmonds | Edmonds Washington, United States, 98026Providence Regional Cancer Partnership | Everett Washington, United States, 98201UW Medicine Valley Medical Center | Renton Washington, United States, 98055Swedish Medical Center | Seattle Washington, United States, 98104Deaconess Hospital | Spokane Washington, United States, 99204Cancer Care Northwest - Vercler | Spokane Valley Washington, United States, 99216MultiCare Health System | Tacoma Washington, United States, 98405North Star Lodge | Yakima Washington, United States, 98902ThedaCare Physicians - Appleton North | Appleton Wisconsin, United States, 54911CIPREC | Buenos Aires , Argentina, 1061Investigaciones Clinicas Moleculares (ICM) | Buenos Aires , Argentina, 1425Centro Oncologico Korben | Buenos Aires , Argentina, 1426Hospital Medico Policial Churruca-Visca | Buenos Aires , Argentina, 1437Organizacion Medica de Investigacion | Buenos Aires , Argentina, C1015ABOFundación Innovaciencia | Rosario , Argentina, 2000Hospital Provincial del Centenario | Rosario , Argentina, S2002KDSCOE (Centro Oncológico de Excelencia) | San Juan , Argentina, 5400Instituto San Marcos | San Juan , Argentina, 5400Go Centro Medico San Nicolás | San Nicolás , Argentina, 2900Ballarat Health Services | Ballarat Central , Australia, 3350The Prince Charles Hospital | Brisbane , Australia, 4032St Vincent's Hospital | Darlinghurst , Australia, 2010Peter MacCallum Cancer Centre | Melbourne , Australia, 3000Lake Macquarie Private Hospital | Newcastle , Australia, 2290Macquarie University | North Ryde , Australia, 2109Goulburn Valley Health | Shepparton , Australia, 3630St. John of God Subiaco Hospital | Subiaco , Australia, 6008The Townsville Hospital | Townsville , Australia, 4814Institut Jules Bordet | Anderlecht , Belgium, 1070Jessa Ziekenhuis | Hasselt , Belgium, 3500AZ Groeninge Campus Kennedylaan | Kortrijk , Belgium, 8500UZ Leuven | Leuven , Belgium, 3000CHU UCL Namur/Site Sainte Elisabeth | Namur , Belgium, 5000Clinique Saint Pierre | Ottignies , Belgium, 1340AZ Nikolaas | Sint-Niklaas , Belgium, B-9100Fundação Pio XII - Hospital de Câncer de Barretos | Barretos , Brazil, 14784400Hospital São Domingos | Bequimão , Brazil, 65060-645Centro de Pesquisa Clínica do Instituto do Câncer do Ceará | Fortaleza , Brazil, 60430235Hospital Araújo Jorge | Goiânia , Brazil, 74605070Hospital Brasilia | Lago Sul , Brazil, 71635580Hospital de Cancer de Londrina | Londrina , Brazil, 86015-520Instituto Atena de Pesquisa Clinica - Mossoró | Mossoró , Brazil, 59603-020Liga Norte Riograndense Contra o Câncer | Natal , Brazil, 59062-000Hospital São Lucas da PUCRS | Porto Alegre , Brazil, 90610-000Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA | Rio de Janeiro , Brazil, 22250-905Instituto do Cancer Arnaldo Vieira de Carvalho | São Paulo , Brazil, 01221-020Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo , Brazil, 01246-000Hospital Santa Catarina - Paulista | São Paulo , Brazil, 01310-000Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda | São Paulo , Brazil, 01317-000IBCC - Núcleo de Pesquisa e Ensino | São Paulo , Brazil, 04014-002Hamilton Health Sciences-Juravinski Cancer Centre | Hamilton , Canada, L8V5C2CHU de Québec-Université Laval, Hôpital du Saint-Sacrement | Québec , Canada, G1S 4L8Princess Margaret Cancer Centre | Toronto , Canada, M5G 2M9Anyang Cancer Hospital | Anyang , China, 455000Beijing Cancer hospital | Beijing , China, 100142The First Hospital of Jilin University | Changchun , China, 130021The First People's Hospital of Changde City | Changde , China, 415003Xiangya Hospital Central South University | Changsha , China, 410008Sichuan Provincial People's Hospital | Chengdu , China, 610072Deyang City People's Hospital | Deyang , China, 618099Fujian Cancer Hospital | Fuzhou , China, 350014Fujian Medical University Union Hospital | Fuzhou Fujian , China, 350001Sun Yat-sen University Cancer Center | Guangzhou , China, 510060Guangdong Provincial People's Hospital | Guangzhou , China, 510080Harbin Medical University Cancer Hospital | Harbin , China, 150081Jiangmen Center Hospital | Jiangmen , China, The first affiliated hospital of Ningbo university | Ningbo , China, 315010Fudan University Shanghai Cancer Center | Shanghai , China, 200032Cancer Hospital of Shantou University Medical College | Shantou , China, 515031The First Hospital of China Medical University | Shenyang , China, 110001Tianjin Medical University Cancer Institute & Hospital | Tianjin , China, 300060Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan , China, 430022Tongji Hospital Tongji Medical,Science & Technology | Wuhan , China, 430030Central Hospital of Guangdong Provincial Agricutural Reclamation | Zhanjiang , China, 524002Sainte Catherine Institut du Cancer Avignon Provence | Avignon , France, 84918CHU Besançon | Besançon , France, 25000CHRU de Brest | Brest , France, 29609Clinique Victor Hugo Le Mans | Le Mans , France, 72000Hopital Prive Jean Mermoz | Lyon , France, 69008Centre de Cancérologie du Grand Montpellier | Montpellier , France, 34070Institut Curie | Paris , France, 75248Institut Jean Godinot | Reims , France, 51726Institut Curie - site Saint-Cloud | Saint-Cloud , France, 92210Institut de Cancérologie de l'Ouest | Saint-Herblain , France, 44805Oncopole Claudius Regaud | Toulouse , France, 31059Institut de Cancérologie de Lorraine Alexis Vautrin | Vandœuvre-lès-Nancy , France, 54519Gustave Roussy | Villejuif , France, 94800Charité Universitaetsmedizin Berlin - Campus Mitte | Berlin , Germany, 10117Marienhospital Bottrop | Bottrop , Germany, 46236Universitaetsklinikum Koeln | Cologne , Germany, 50937Städtisches Klinikum Dessau | Dessau , Germany, 06847Onkologiezentrum Donauwörth | Donauwörth , Germany, 86609Universitaetsklinikum Carl Gustav Carus Dresden | Dresden , Germany, 01307MVZ Medical Center Düsseldorf GmbH | Düsseldorf , Germany, 40235Universitaetsklinikum Erlangen | Erlangen , Germany, 91054Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung | Essen , Germany, 45136Agaplesion Markus Krankenhaus | Frankfurt , Germany, 60431Universitaetsklinikum Freiburg | Freiburg im Breisgau , Germany, 79106Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer | Friedrichshafen , Germany, 88045OSP Göttingen | Göttingen , Germany, 37073Mammazentrum HH - Krankenhaus Jerusalem | Hamburg , Germany, 20357Universitaetsklinikum des Saarlandes | Homburg , Germany, 66424Universitätsklinikum Leipzig | Leipzig , Germany, 04103Klinikum Ludwigsburg | Ludwigsburg , Germany, 71640Universitätsmedizin Johannes Gutenberg Universität Mainz | Mainz , Germany, 55131Klinikum der Ludwig-Maximilians-Universitaet Muenchen | München , Germany, 80336Klinikum Ernst von Bergmann | Potsdam , Germany, 14467SRH Zentralklinikum Suhl | Suhl , Germany, 98527Helios HSK Wiesbaden | Wiesbaden , Germany, 65199Marien Hospital Witten | Witten , Germany, 58452HELIOS Klinikum Wuppertal | Wuppertal , Germany, 42283Agios Savvas Regional Cancer Hospital | Athens , Greece, 115 22Aretaieio Hospital | Athens , Greece, 115 28Attikon General University Hospital | Chaïdári , Greece, 12462University General Hospital of Heraklion | Heraklion , Greece, 715 00University Hospital of Ioannina | Ioannina , Greece, 455 00University General Hospital of Larissa | Larissa , Greece, 41110University Hospital of Patras | Pátrai , Greece, 26504European Interbalkan Medical Center | Thessaloniki , Greece, 54639European Interbalkan Medical Center | Thessaloniki , Greece, 570 01European Interbalkan Medical Center | Thessaloniki , Greece, 570 01St. Vincent's University Hospital | Dublin , Ireland, D04 T6F4Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo , Italy, 24127IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Bologna , Italy, 40138Azienda Ospedaliera Universitaria Careggi | Florence , Italy, 50134Ospedale San Martino | Genova , Italy, 16132Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola , Italy, 47014Istituto Europeo di Oncologia IRCCS | Milan , Italy, 20141Humanitas Istituto Clinico Catanese | Misterbianco , Italy, 95045Fondazione IRCCS San Gerardo dei Tintori | Monza , Italy, 20900Azienda Ospedaliera Universitaria Federico II | Naples , Italy, 80131Istituto Nazionale Tumori IRCCS Fondazione Pascale | Naples , Italy, 80131Istituto Oncologico Veneto IRCCS | Padova , Italy, 35128Fondazione Policlinico Universitario Agostino Gemelli | Roma , Italy, 00168Juntendo University Hospital | Bunkyō City , Japan, 113-8431Chiba cancer center | Chiba , Japan, 260-8717National Hospital Organization Kyushu Cancer Center | Fukuoka , Japan, 811-1395Kyushu University Hospital | Fukuoka , Japan, 812-8582Fukushima Medical University | Fukushima , Japan, 960-1295Saitama Medical University International Medical Center | Hidaka , Japan, 350-1298Kansai Medical University Hospital | Hirakata , Japan, 573-1191Hiroshima City Hospital | Hiroshima , Japan, 730-8518Hiroshima University Hospital | Hiroshima , Japan, 734-8551Sagara Hospital | Kagoshima , Japan, 892-0833Kanazawa Medical University Hospital | Kahoku-gun , Japan, 920-0293The Cancer Institute Hospital of JFCR | Kōtoku , Japan, 135-8550Kyoto University Hospital | Kyoto , Japan, 606-8507Nagoya City University Hospital | Nagoya , Japan, 467-8602Nakagami Hospital | Okinawa , Japan, 904-2142Gunma Prefectural Cancer Center | Otashi , Japan, 373-8550Saitama Red Cross Hospital | Saitama , Japan, 330-8553Hokkaido University Hospital | Sapporo , Japan, 060-8648Tohoku University Hospital | Sendai , Japan, 980-8574Showa Medical University Hospital | Shinagawa City , Japan, 142-8666Shizuoka General Hospital | Shizuoka , Japan, 420-8527The University of Osaka Hospital | Suita , Japan, 565-0871Tsukuba University Hospital | Tsukuba , Japan, 305-8576Kanagawa cancer center | Yokohama , Japan, 2418515Soon Chun Hyang University Cheonan Hospital | Cheonan-si , South Korea, 31151Kyungpook National University Chilgok Hospital | Deagu , South Korea, 41404Gangnam Severance Hospital, Yonsei University Health System | Gangnam-gu , South Korea, 06273Yeungnam Univeristy Medical Center | Gyeongsan-si , South Korea, 42415Inha University Hospital | Incheon , South Korea, 22332Korea University Anam Hospital | Seoul , South Korea, 02841Seoul National University Hospital | Seoul , South Korea, 03080Severance Hospital, Yonsei University Health System | Seoul , South Korea, 03722Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 06351Hospital Infanta Cristina | Badajoz , Spain, 06006Hospital Universitari Dexeus | Barcelona , Spain, 08028Hospital Universitari Vall d'Hebron | Barcelona , Spain, 08035Hospital San Pedro de Alcántara | Cáceres , Spain, 10003Hospital Universitario Donostia | Donostia / San Sebastian , Spain, 20014Hospital Universitario San Cecilio | Granada , Spain, 18016Instituto Catalan de Oncologia - Hospital Duran i Reynals | Hospitalet , Spain, 08907Complejo Hospitalario de Jaén | Jaén , Spain, 23007Hospital Insular de Gran Canaria | Las Palmas de Gran Canaria , Spain, 35016Hospital Universitario Arnau de Vilanova de Lleida | Lleida , Spain, 25198Hospital Beata María Ana | Madrid , Spain, 28007Hospital General Universitario Gregorio Marañon | Madrid , Spain, 28009Hospital Universitario Ramón y Cajal | Madrid , Spain, 28034Hospital Clinico San Carlos | Madrid , Spain, 28040Hospital Universitario 12 de Octubre | Madrid , Spain, 28041Hospital Universitario HM Sanchinarro | Madrid , Spain, 28050Hospital Universitario Virgen de la Victoria | Málaga , Spain, 29010Hospital Universitari Son Espases | Palma , Spain, 07120Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Salamanca , Spain, 37007Hospital Universitario de Canarias | San Cristóbal de La Laguna , Spain, 38320CHUS - Hospital Clinico Universitario | Santiago de Compostela , Spain, 15706Hospital Universitario Virgen Macarena | Seville , Spain, 41009Hospital Universitario Virgen Del Rocio | Seville , Spain, 41013Fundación Instituto Valenciano de Oncología | Valencia , Spain, 46009Hospital Clinico de Valencia | Valencia , Spain, 46010Hospital Arnau de Vilanova | Valencia , Spain, 46015Hospital Clínico Universitario Lozano Blesa | Zaragoza , Spain, 50009Taichung Veterans General Hospital | Taichung , Taiwan, 407National Cheng Kung University Hospital | Tainan , Taiwan, 704Chi Mei Medical Center | Tainan , Taiwan, 71004National Taiwan University Hospital | Taipei , Taiwan, 10002Taipei Veterans General Hospital | Taipei , Taiwan, 11217Baskent University Dr. Turgut Noyan Research and Training Center | Adana , Turkey (Türkiye), 01250Adana City Hospital | Adana , Turkey (Türkiye), 01370Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi | Ankara , Turkey (Türkiye), 06200Ankara University Health Practice and Research Hospitals | Ankara , Turkey (Türkiye), 06620Ege Universitesi Hastanesi | Bornova , Turkey (Türkiye), 35100Trakya University | Edirne , Turkey (Türkiye), 22030Koç Üniversitesi Hastanesi | Istanbul , Turkey (Türkiye), 34010Yeditepe Üniversitesi Koşuyolu Hastanesi | Istanbul , Turkey (Türkiye), 34718Western General Hospital | Edinburgh , United Kingdom, EH4 2XUHuddersfield Royal Infirmary | Huddersfield , United Kingdom, HD3 3EASt Bartholomew's Hospital | London , United Kingdom, EC1A 7BERoyal Marsden Hospital (Sutton) | London , United Kingdom, SM2 5PTRoyal Marsden Hospital (Chelsea) | London , United Kingdom, SW3 6JJThe Christie NHS Foundation Trust | Manchester , United Kingdom, M20 4BXDerriford Hospital | Plymouth , United Kingdom, Pl6 8DHWorcestershire Royal Hospital | Worcester , United Kingdom, WR5 1DD
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company