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

June 3, 2026 updated by: Eli Lilly and Company

A 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)

The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

920

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Not yet recruiting
        • Centro Oncologico Korben
        • Contact:
          • Phone Number: 5491163819972
        • Principal Investigator:
          • Ernesto Korbenfeld
      • Buenos Aires, Argentina, 1061
        • Not yet recruiting
        • CIPREC
        • Contact:
          • Phone Number: 5491150523121
        • Principal Investigator:
          • Ezequiel Slutsky
      • Buenos Aires, Argentina, C1015ABO
        • Not yet recruiting
        • Organización Médica de Investigación
        • Contact:
          • Phone Number: 1130051657
        • Principal Investigator:
          • Margarita Alfie
      • Buenos Aires, Argentina, 1425
        • Not yet recruiting
        • Investigaciones Clinicas Moleculares (ICM)
        • Principal Investigator:
          • Nicolas Torressi
      • Buenos Aires, Argentina, 1437
        • Not yet recruiting
        • Hospital Medico Policial Churruca-Visca
        • Contact:
          • Phone Number: 01163747774
        • Principal Investigator:
          • DANIEL MALDONADO
      • Rosario, Argentina, S2002KDS
        • Not yet recruiting
        • Hospital Provincial del Centenario
        • Contact:
          • Phone Number: 341-5717551
        • Principal Investigator:
          • Andrea Pastor
      • Rosario, Argentina, 2000
        • Not yet recruiting
        • Fundacion Innovaciencia
        • Principal Investigator:
          • Mariana Queralt
      • San Juan, Argentina, 5400
        • Not yet recruiting
        • Instituto San Marcos
        • Contact:
          • Phone Number: 549-264-4826407
        • Principal Investigator:
          • Alejandro Roses Videla
      • San Juan, Argentina, 5400
        • Not yet recruiting
        • COE (Centro Oncológico de Excelencia)
        • Contact:
          • Phone Number: 542644211086
        • Principal Investigator:
          • Juan Puig
      • San Nicolás, Argentina, 2900
        • Not yet recruiting
        • Go Centro Medico San Nicolás
        • Contact:
          • Phone Number: 03364456047
        • Principal Investigator:
          • Vanina Binner
  • Australia
      • Ballarat Central, Australia, 3350
        • Not yet recruiting
        • Ballarat Health Services
        • Principal Investigator:
          • James Ridgwell
      • Brisbane, Australia, 4032
        • Not yet recruiting
        • The Prince Charles Hospital
        • Contact:
          • Phone Number: 61 7 3176 2111
        • Principal Investigator:
          • Kyung Ha (Kathy) You
      • Darlinghurst, Australia, 2010
        • Recruiting
        • St Vincent's Hospital
        • Principal Investigator:
          • Elgene Lim
        • Contact:
          • Phone Number: 0293555652
      • Hobart, Australia, 7000
        • Not yet recruiting
        • Royal Hobart Hospital
        • Contact:
          • Phone Number: 0361666655
        • Principal Investigator:
          • Melanie Wuttke
      • Melbourne, Australia, 3000
        • Not yet recruiting
        • Peter MacCallum Cancer Centre
        • Principal Investigator:
          • Sherene Loi
        • Contact:
          • Phone Number: 61385595935
      • Newcastle, Australia, 2290
        • Recruiting
        • Lake Macquarie Private Hospital
        • Principal Investigator:
          • Nicholas Zdenkowski
        • Contact:
          • Phone Number: 0424579224
      • North Ryde, Australia, 2109
        • Not yet recruiting
        • Macquarie University
        • Principal Investigator:
          • Dhanusha Sabanathan
      • Shepparton, Australia, 3630
        • Recruiting
        • Goulburn Valley Health
        • Principal Investigator:
          • Arvind Sahu
        • Contact:
          • Phone Number: +61 3 5832 2322
      • Subiaco, Australia, 6008
        • Recruiting
        • St. John of God Subiaco Hospital
        • Principal Investigator:
          • Daphne Tsoi
      • Townsville, Australia, 4814
        • Not yet recruiting
        • The Townsville Hospital
        • Contact:
          • Phone Number: 61744331111
        • Principal Investigator:
          • Joanne Tan
  • Belgium
      • Anderlecht, Belgium, 1070
        • Not yet recruiting
        • Institut Jules Bordet
        • Contact:
          • Phone Number: 3225413188
        • Principal Investigator:
          • Philippe Aftimos
      • Hasselt, Belgium, 3500
        • Not yet recruiting
        • Jessa Ziekenhuis
        • Principal Investigator:
          • Jeroen Mebis
        • Contact:
          • Phone Number: +3211337979
      • Kortrijk, Belgium, 8500
        • Not yet recruiting
        • AZ Groeninge Campus Kennedylaan
        • Principal Investigator:
          • Laure Nuytemans
        • Contact:
          • Phone Number: 3256633900
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
        • Principal Investigator:
          • Patrick Neven
        • Contact:
          • Phone Number: 003216345129
      • Namur, Belgium, 5000
        • Not yet recruiting
        • CHU UCL Namur/Site Sainte Elisabeth
        • Contact:
          • Phone Number: 003281720524
        • Principal Investigator:
          • Donatienne Taylor
      • Ottignies, Belgium, 1340
        • Not yet recruiting
        • Clinique Saint Pierre
        • Principal Investigator:
          • Renaud Poncin
        • Contact:
          • Phone Number: 003210437648
      • Sint-Niklaas, Belgium, B-9100
        • Not yet recruiting
        • AZ Nikolaas
        • Contact:
          • Phone Number: 3237602975
        • Principal Investigator:
          • Ines Deleu
  • Brazil
      • Barretos, Brazil, 14784400
        • Not yet recruiting
        • Fundacao Pio XII - Hospital de Cancer de Barretos
        • Contact:
          • Phone Number: 551733216637
        • Principal Investigator:
          • Ana Suellen Barroso Carneiro
      • Bequimão, Brazil, 65060-645
        • Not yet recruiting
        • Hospital Sao Domingos
        • Contact:
          • Phone Number: +55 (98) 991187100
        • Principal Investigator:
          • Ana Fonseca Alves
      • Fortaleza, Brazil, 60430235
        • Not yet recruiting
        • Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
        • Principal Investigator:
          • Jailson de Sousa Oliveira
      • Goiânia, Brazil, 74605070
        • Not yet recruiting
        • Hospital Araujo Jorge
        • Principal Investigator:
          • Ruffo Freitas-Junior
      • Lago Sul, Brazil, 71635580
        • Not yet recruiting
        • Hospital Brasilia
        • Principal Investigator:
          • Romualdo Barroso-Sousa
      • Londrina, Brazil, 86015-520
        • Not yet recruiting
        • Hospital de Cancer de Londrina
        • Principal Investigator:
          • Vitor Liutti
        • Contact:
          • Phone Number: 55433792608
      • Mossoró, Brazil, 59603-020
        • Not yet recruiting
        • Instituto Atena de Pesquisa Clinica - Mossoró
        • Principal Investigator:
          • Stephanie Dantas
      • Natal, Brazil, 59062-000
        • Not yet recruiting
        • Liga Norte Riograndense contra o cancer
        • Contact:
          • Phone Number: +55 84 4009 5595
        • Principal Investigator:
          • Luciana Aquino Pimentel
      • Porto Alegre, Brazil, 90610-000
        • Not yet recruiting
        • Hospital Sao Lucas da PUCRS
        • Contact:
          • Phone Number: 555133203039
        • Principal Investigator:
          • Fernanda Damian
      • Rio de Janeiro, Brazil, 22250-905
        • Not yet recruiting
        • Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
        • Principal Investigator:
          • Gustavo Bretas
      • São Paulo, Brazil, 01246-000
        • Not yet recruiting
        • ICESP - Instituto do Cancer do Estado de Sao Paulo
        • Contact:
          • Phone Number: 551138933525
        • Principal Investigator:
          • Marcela Ferrari
      • São Paulo, Brazil, 01317-000
        • Not yet recruiting
        • Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
        • Principal Investigator:
          • Roberto Hegg
        • Contact:
          • Phone Number: 551123598425
      • São Paulo, Brazil, 01310-000
        • Not yet recruiting
        • Hospital Santa Catarina - Paulista
        • Contact:
          • Phone Number: 5511983366440
        • Principal Investigator:
          • Aumilto Da Silva Junior
      • São Paulo, Brazil, 04014-002
        • Not yet recruiting
        • IBCC - Núcleo de Pesquisa e Ensino
        • Principal Investigator:
          • Larissa Paula
        • Contact:
          • Phone Number: 55 11 4450-0300
      • São Paulo, Brazil, 01221-020
        • Not yet recruiting
        • Instituto do Cancer Arnaldo Vieira de Carvalho
        • Contact:
          • Phone Number: +5511956598420
        • Principal Investigator:
          • Patricia Marubayashi
  • Canada
      • Hamilton, Canada, L8V5C2
        • Not yet recruiting
        • Hamilton Health Sciences-Juravinski Cancer Centre
        • Principal Investigator:
          • Haider Samawi
      • Québec, Canada, G1S 4L8
        • Not yet recruiting
        • CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
        • Principal Investigator:
          • Julie Lemieux
      • Toronto, Canada, M5G 2M9
        • Not yet recruiting
        • Princess Margaret Cancer Centre
        • Principal Investigator:
          • Philippe Bedard
        • Contact:
          • Phone Number: 416 946 4534
  • China
      • Anyang, China, 455000
        • Not yet recruiting
        • Anyang Cancer Hospital
        • Principal Investigator:
          • Junlan Guo
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital
        • Contact:
          • Phone Number: 86 13811012595
        • Principal Investigator:
          • Huiping Li
      • Changchun, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Principal Investigator:
          • Lihua Kang
      • Changde, China, 415003
        • Recruiting
        • The First People's Hospital of Changde City
        • Principal Investigator:
          • Tao Wu
      • Changsha, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Principal Investigator:
          • Juan Huang
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Jing Luo
        • Contact:
          • Phone Number: 18981838521
      • Deyang, China, 618099
        • Not yet recruiting
        • Deyang City People's Hospital
        • Principal Investigator:
          • Xinjian Jia
      • Fuzhou, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Phone Number: 13960709993
        • Principal Investigator:
          • Chuangui Song
      • Fuzhou Fujian, China, 350001
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Principal Investigator:
          • Jie Zhang
      • Guangzhou, China, 510060
        • Not yet recruiting
        • Sun yat-sen University Cancer Center
        • Principal Investigator:
          • Fei Xu
      • Guangzhou, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Principal Investigator:
          • Kun Wang
      • Harbin, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Li Cai
      • Jiangmen, China, 529030
        • Recruiting
        • Jiangmen Center Hospital
        • Contact:
          • Phone Number: 18933183766
        • Principal Investigator:
          • XIAOPING LI
      • Ningbo, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Principal Investigator:
          • Yu Guo
        • Contact:
          • Phone Number: 0574-87085588
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Phone Number: 13601637369
        • Principal Investigator:
          • Jiong Wu
      • Shantou, China, 515031
        • Recruiting
        • Cancer Hospital of Shantou University Medical College
        • Principal Investigator:
          • De Zeng
      • Shenyang, China, 110001
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Principal Investigator:
          • Yuee Teng
      • Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Principal Investigator:
          • Yehui Shi
      • Wuhan, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Principal Investigator:
          • Tao Huang
      • Wuhan, China, 430030
        • Not yet recruiting
        • Tongji Hospital Tongji Medical,Science & Technology
        • Principal Investigator:
          • huihua xiong
      • Zhanjiang, China, 524002
        • Not yet recruiting
        • Central Hospital of Guangdong Provincial Agricutural Reclamation
        • Principal Investigator:
          • Yuanyuan Li
  • France
      • Avignon, France, 84918
        • Not yet recruiting
        • Sainte Catherine Institut du Cancer Avignon Provence
        • Principal Investigator:
          • Julien Grenier
        • Contact:
          • Phone Number: 33490276397
      • Besançon, France, 25000
        • Not yet recruiting
        • CHU Besançon
        • Contact:
          • Phone Number: 33370632403
        • Principal Investigator:
          • Laura Mansi
      • Brest, France, 29609
        • Not yet recruiting
        • CHRU de Brest
        • Principal Investigator:
          • Laura Deiana
      • Le Mans, France, 72000
        • Not yet recruiting
        • Clinique Victor Hugo Le Mans
        • Principal Investigator:
          • Sophie Roche
      • Lyon, France, 69008
        • Not yet recruiting
        • Hopital Prive Jean Mermoz
        • Contact:
          • Phone Number: 0659321781
        • Principal Investigator:
          • Olfa DERBEL
      • Montpellier, France, 34070
        • Not yet recruiting
        • Centre de Cancérologie du Grand Montpellier
        • Principal Investigator:
          • Cristian Villanueva
        • Contact:
          • Phone Number: 467926155
      • Paris, France, 75248
        • Not yet recruiting
        • Institut Curie
        • Contact:
          • Phone Number: +33172389434
        • Principal Investigator:
          • Paul COTTU
      • Plérin, France, 22190
        • Not yet recruiting
        • Hôpital Privé des Côtes d'Armor
        • Principal Investigator:
          • Jerome Martin-Babau
      • Reims, France, 51726
        • Not yet recruiting
        • Institut Jean Godinot
        • Principal Investigator:
          • Pauline Soibinet
      • Saint-Cloud, France, 92210
        • Not yet recruiting
        • Institut Curie - site Saint-Cloud
        • Contact:
          • Phone Number: +33172389434
        • Principal Investigator:
          • Paul COTTU
      • Saint-Herblain, France, 44805
        • Not yet recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
          • Phone Number: 33240679977
        • Principal Investigator:
          • Mario Campone
      • Toulouse, France, 31059
        • Not yet recruiting
        • Oncopole Claudius Regaud
        • Principal Investigator:
          • Eleonora De Maio
        • Contact:
          • Phone Number: 0531155127
      • Vandœuvre-lès-Nancy, France, 54519
        • Not yet recruiting
        • Institut de Cancérologie de Lorraine Alexis Vautrin
        • Principal Investigator:
          • Vincent Massard
      • Villejuif, France, 94800
        • Not yet recruiting
        • Gustave Roussy
        • Principal Investigator:
          • Cyril Roussel-simonin
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte
        • Principal Investigator:
          • Caroline Neeb
      • Bottrop, Germany, 46236
        • Not yet recruiting
        • Marienhospital Bottrop
        • Contact:
          • Phone Number: 4920411061601
        • Principal Investigator:
          • Hans-Christian Kolberg
      • Cologne, Germany, 50937
        • Not yet recruiting
        • Universitaetsklinikum Koeln
        • Contact:
          • Phone Number: 004922147837567
        • Principal Investigator:
          • Christian Maurer
      • Dessau, Germany, 06847
        • Not yet recruiting
        • Städtisches Klinikum Dessau
        • Contact:
          • Phone Number: 00493405014310
        • Principal Investigator:
          • Hermann Voss
      • Donauwörth, Germany, 86609
        • Not yet recruiting
        • Onkologiezentrum Donauwörth
        • Principal Investigator:
          • Bastian Fleischmann
        • Contact:
          • Phone Number: 49990629993911
      • Dresden, Germany, 01307
        • Not yet recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden
        • Principal Investigator:
          • Pauline Wimberger
        • Contact:
          • Phone Number: 00493514586728
      • Düsseldorf, Germany, 40235
        • Not yet recruiting
        • Kostara Gyn. Oncology Clinic Research UG
        • Contact:
          • Phone Number: 4921144773360
        • Principal Investigator:
          • Athina Kostara
      • Erlangen, Germany, 91054
        • Not yet recruiting
        • Universitaetsklinikum Erlangen
        • Principal Investigator:
          • Peter Fasching
        • Contact:
          • Phone Number: +4991318533572
      • Essen, Germany, 45136
        • Not yet recruiting
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
        • Principal Investigator:
          • Sherko Kümmel
        • Contact:
          • Phone Number: +4920117433005
      • Frankfurt, Germany, 60431
        • Not yet recruiting
        • Agaplesion Markus Krankenhaus
        • Contact:
          • Phone Number: 00496995332228
        • Principal Investigator:
          • Marc Thill
      • Freiburg im Breisgau, Germany, 79106
        • Not yet recruiting
        • Universitaetsklinikum Freiburg
        • Contact:
          • Phone Number: 004927030020
        • Principal Investigator:
          • Beate Rautenberg
      • Friedrichshafen, Germany, 88045
        • Not yet recruiting
        • Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer
        • Principal Investigator:
          • Frank Mayer
      • Göttingen, Germany, 37073
        • Not yet recruiting
        • OSP Göttingen
        • Principal Investigator:
          • Michael Metz
        • Contact:
          • Phone Number: 0049551488795915
      • Hamburg, Germany, 20357
        • Not yet recruiting
        • Mammazentrum HH - Krankenhaus Jerusalem
        • Principal Investigator:
          • Christian Schem
      • Homburg, Germany, 66424
        • Not yet recruiting
        • Universitaetsklinikum des Saarlandes
        • Contact:
          • Phone Number: 4968411628101
        • Principal Investigator:
          • Julia Radosa
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Universitätsklinikum Leipzig
        • Principal Investigator:
          • Bahriye Aktas
        • Contact:
          • Phone Number: +493419723400
      • Ludwigsburg, Germany, 71640
        • Not yet recruiting
        • Klinikum Ludwigsburg
        • Contact:
          • Phone Number: 004971419990
        • Principal Investigator:
          • Claudia Haenle
      • Mainz, Germany, 55131
        • Not yet recruiting
        • Universitätsmedizin Johannes Gutenberg Universität Mainz
        • Contact:
          • Phone Number: 00496131170
        • Principal Investigator:
          • Marcus Schmidt
      • München, Germany, 80336
        • Not yet recruiting
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen
        • Principal Investigator:
          • Nadia Harbeck
        • Contact:
          • Phone Number: 004989440077581
      • Potsdam, Germany, 14467
        • Not yet recruiting
        • Klinikum Ernst von Bergmann
        • Principal Investigator:
          • Dorothea Fischer
        • Contact:
          • Phone Number: +4933124135643
      • Suhl, Germany, 98527
        • Not yet recruiting
        • SRH Zentralklinikum Suhl
        • Principal Investigator:
          • Uwe Rhein
        • Contact:
          • Phone Number: 00493681355016
      • Wiesbaden, Germany, 65199
        • Not yet recruiting
        • Helios HSK Wiesbaden
        • Contact:
          • Phone Number: 0049611432377
        • Principal Investigator:
          • Michael Eichbaum
      • Witten, Germany, 58452
        • Not yet recruiting
        • Marien Hospital Witten
        • Principal Investigator:
          • Monika Graeser
        • Contact:
          • Phone Number: 004923021733290
      • Wuppertal, Germany, 42283
        • Not yet recruiting
        • Helios Klinikum Wuppertal
        • Principal Investigator:
          • Vesna Bjelic-Radisic
        • Contact:
          • Phone Number: 0492028961411
  • Greece
      • Athens, Greece, 115 22
        • Not yet recruiting
        • Agios Savvas Regional Cancer Hospital
        • Principal Investigator:
          • Dimitrios Tryfonopoulos
      • Athens, Greece, 115 28
        • Not yet recruiting
        • Aretaieio Hospital
        • Principal Investigator:
          • FLORA ZAGOURI
        • Contact:
          • Phone Number: 306946462998
      • Chaïdári, Greece, 12462
        • Not yet recruiting
        • Attikon General University Hospital
        • Contact:
          • Phone Number: 302105831265
        • Principal Investigator:
          • Amanda Psyrri
      • Heraklion, Greece, 715 00
        • Not yet recruiting
        • University General Hospital of Heraklion
        • Principal Investigator:
          • Dimitrios Mavroudis
        • Contact:
          • Phone Number: 2810-392750
      • Ioannina, Greece, 455 00
        • Not yet recruiting
        • University Hospital of Ioannina
        • Principal Investigator:
          • STERGIOS BOUSSIOS
      • Larissa, Greece, 41110
        • Not yet recruiting
        • University General Hospital of Larissa
        • Principal Investigator:
          • Athanasios Kotsakis
        • Contact:
          • Phone Number: 302413502785
      • Pátrai, Greece, 26504
        • Not yet recruiting
        • University Hospital of Patras
        • Contact:
          • Phone Number: 302610999791
        • Principal Investigator:
          • Angelos Koutras
      • Thessaloniki, Greece, 570 01
        • Not yet recruiting
        • European Interbalkan Medical Center
        • Principal Investigator:
          • Sofia Baka
      • Thessaloniki, Greece, 54639
        • Not yet recruiting
        • European Interbalkan Medical Center
        • Principal Investigator:
          • Ippokratis Korantzis
        • Contact:
          • Phone Number: 306974000528
  • Ireland
      • Dublin, Ireland, D04 T6F4
        • Not yet recruiting
        • St. Vincent's University Hospital
        • Contact:
          • Phone Number: 012214000
        • Principal Investigator:
          • Janice Walshe
  • Italy
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
        • Principal Investigator:
          • Alberto Zambelli
      • Bologna, Italy, 40138
        • Not yet recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Principal Investigator:
          • Claudio Zamagni
      • Florence, Italy, 50134
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Principal Investigator:
          • Icro Meattini
      • Genova, Italy, 16132
        • Not yet recruiting
        • Ospedale San Martino
        • Principal Investigator:
          • Lucia Del Mastro
        • Contact:
          • Phone Number: 390105558904
      • Meldola, Italy, 47014
        • Not yet recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
        • Principal Investigator:
          • Michela Palleschi
        • Contact:
          • Phone Number: 0039 347 488 6271
      • Milan, Italy, 20141
        • Not yet recruiting
        • Istituto Europeo di Oncologia IRCCS
        • Principal Investigator:
          • Giuseppe Curigliano
        • Contact:
          • Phone Number: 00390257489215
      • Misterbianco, Italy, 95045
        • Not yet recruiting
        • Humanitas Istituto Clinico Catanese
        • Principal Investigator:
          • PAOLO VIGNERI
      • Monza, Italy, 20900
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo Dei Tintori
        • Contact:
          • Phone Number: 390392339037
        • Principal Investigator:
          • Marina Cazzaniga
      • Naples, Italy, 80131
        • Not yet recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
        • Principal Investigator:
          • Michelino De Laurentiis
        • Contact:
          • Phone Number: 3908117770442
      • Naples, Italy, 80131
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Principal Investigator:
          • Grazia Arpino
        • Contact:
          • Phone Number: +390817463660
      • Padova, Italy, 35128
        • Not yet recruiting
        • Istituto Oncologico Veneto IRCCS
        • Principal Investigator:
          • Valentina Guarneri
        • Contact:
          • Phone Number: 0039 0498 215931
      • Roma, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli
        • Principal Investigator:
          • IDA PARIS
        • Contact:
          • Phone Number: 393393018718
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Not yet recruiting
        • Juntendo University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Junichiro Watanabe
      • Chiba, Japan, 260-8717
        • Not yet recruiting
        • Chiba Cancer Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Rikiya Nakamura
      • Fukuoka, Japan, 811-1395
        • Not yet recruiting
        • National Hospital Organization Kyushu Cancer Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Eriko Tokunaga
      • Fukuoka, Japan, 812-8582
        • Not yet recruiting
        • Kyushu University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Makoto Kubo
      • Fukushima, Japan, 960-1295
        • Not yet recruiting
        • Fukushima Medical University
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shigehira Saji
      • Hidaka, Japan, 350-1298
        • Not yet recruiting
        • Saitama Medical University International Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroshi Ishiguro
      • Hirakata, Japan, 573-1191
        • Not yet recruiting
        • Kansai Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masahiro Takada
      • Hiroshima, Japan, 734-8551
        • Not yet recruiting
        • Hiroshima University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hideo Shigematsu
      • Hiroshima, Japan, 730-8518
        • Not yet recruiting
        • Hiroshima City Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Mitsuya Itoh
      • Kagoshima, Japan, 892-0833
        • Not yet recruiting
        • Sagara Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tetsuhiko Taira
      • Kahoku-gun, Japan, 920-0293
        • Not yet recruiting
        • Kanazawa Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masafumi Inokuchi
      • Kyoto, Japan, 606-8507
        • Not yet recruiting
        • Kyoto University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Norikazu Masuda
      • Kōtoku, Japan, 135-8550
        • Not yet recruiting
        • The Cancer Institute Hospital of JFCR
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yukinori Ozaki
      • Nagoya, Japan, 467-8602
        • Not yet recruiting
        • Nagoya City University Hospital
        • Principal Investigator:
          • Tatsuya Toyama
        • Contact:
          • Phone Number: 81120023812
      • Nagoya, Japan, 464-8681
        • Not yet recruiting
        • Aichi Cancer Center Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Fumikata Hara
      • Okinawa, Japan, 904-2142
        • Not yet recruiting
        • Nakagami Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • NORIE ABE
      • Otashi, Japan, 373-8550
        • Not yet recruiting
        • Gunma Prefectural Cancer Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomomi Fujisawa
      • Saitama, Japan, 330-8553
        • Not yet recruiting
        • Saitama Red Cross Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kokoro Kobayashi
      • Sapporo, Japan, 060-8648
        • Not yet recruiting
        • Hokkaido University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masato Takahashi
      • Sendai, Japan, 980-8574
        • Not yet recruiting
        • Tohoku University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Minoru Miyashita
      • Shinagawa City, Japan, 142-8666
        • Not yet recruiting
        • Showa Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hitomi Sakai
      • Shizuoka, Japan, 420-8527
        • Not yet recruiting
        • Shizuoka General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Michiko Tsuneizumi
      • Suita, Japan, 565-0871
        • Not yet recruiting
        • The University of Osaka Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tetsuhiro Yoshinami
      • Tsukuba, Japan, 305-8576
        • Not yet recruiting
        • Tsukuba University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroko Bando
      • Yokohama, Japan, 2418515
        • Not yet recruiting
        • Kanagawa Cancer Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Toshinari Yamashita
  • South Korea
      • Cheonan-si, South Korea, 31151
        • Not yet recruiting
        • Soon Chun Hyang University Cheonan Hospital
        • Contact:
          • Phone Number: 82-10-2529-3895
        • Principal Investigator:
          • Han Jo Kim
      • Deagu, South Korea, 41404
        • Not yet recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Yee Soo Chae
        • Contact:
          • Phone Number: +82 53 200 3011
      • Gangnam-gu, South Korea, 06273
        • Not yet recruiting
        • Gangnam Severance Hospital, Yonsei University Health System
        • Contact:
          • Phone Number: 020193305
        • Principal Investigator:
          • Jee Hung Kim
      • Gyeongsan-si, South Korea, 42415
        • Not yet recruiting
        • Yeungnam Univeristy Medical Center
        • Contact:
          • Phone Number: 82-10-9314-1980
        • Principal Investigator:
          • Sung Ae Koh
      • Incheon, South Korea, 22332
        • Not yet recruiting
        • Inha University Hospital
        • Principal Investigator:
          • Moon Hee Lee
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Seock-Ah Im
        • Contact:
          • Phone Number: 82220720795
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Joo Hyuk Sohn
        • Contact:
          • Phone Number: 82222288135
      • Seoul, South Korea, 05505
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
          • Phone Number: 82230103217
        • Principal Investigator:
          • Sung-Bae Kim
      • Seoul, South Korea, 02841
        • Not yet recruiting
        • Korea University Anam Hospital
        • Contact:
          • Phone Number: 1047617651
        • Principal Investigator:
          • Kyong Hwa Park
      • Seoul, South Korea, 06351
        • Not yet recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Yeon Hee Park
  • Spain
      • Badajoz, Spain, 06006
        • Not yet recruiting
        • Hospital Infanta Cristina
        • Principal Investigator:
          • JUAN IGNACIO DELGADO MINGORANCE
        • Contact:
          • Phone Number: +34924218040
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Cristina Saura
        • Contact:
          • Phone Number: +34 93 274 60 00
      • Barcelona, Spain, 08028
        • Not yet recruiting
        • Hospital Universitari Dexeus
        • Contact:
          • Phone Number: 34935460139
        • Principal Investigator:
          • Alejandro Martínez Bueno
      • Cáceres, Spain, 10003
        • Not yet recruiting
        • Hospital San Pedro de Alcantara
        • Contact:
          • Phone Number: 34927621612
        • Principal Investigator:
          • Santiago Gonzalez Santiago
      • Donostia / San Sebastian, Spain, 20014
        • Not yet recruiting
        • Hospital Universitario Donostia
        • Contact:
          • Phone Number: 0034943328400
        • Principal Investigator:
          • Ander Urruticoechea
      • Granada, Spain, 18016
        • Not yet recruiting
        • Hospital Universitario San Cecilio
        • Contact:
          • Phone Number: 958840490
        • Principal Investigator:
          • Maria Isabel Blancas López-Barajas
      • Hospitalet, Spain, 08907
        • Not yet recruiting
        • Instituto Catalán de Oncología - Hospital Duran i Reynals
        • Principal Investigator:
          • Rafael Villanueva Vazquez
        • Contact:
          • Phone Number: +34932607283
      • Jaén, Spain, 23007
        • Not yet recruiting
        • Complejo Hospitalario de Jaen
        • Contact:
          • Phone Number: 953220306
        • Principal Investigator:
          • ROCIO URBANO CUBERO
      • Las Palmas de Gran Canaria, Spain, 35016
        • Not yet recruiting
        • Hospital Insular de Gran Canaria
        • Contact:
          • Phone Number: 641971167
        • Principal Investigator:
          • Elena Vicente Rubio
      • Lleida, Spain, 25198
        • Not yet recruiting
        • Hospital Universitario Arnau de Vilanova de Lleida
        • Principal Investigator:
          • SERAFIN MORALES MURILLO
        • Contact:
          • Phone Number: 973003754
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Maria Fernandez Abad
        • Contact:
          • Phone Number: +34913368263
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Phone Number: 34913908626
        • Principal Investigator:
          • Eva María Ciruelos Gil
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Principal Investigator:
          • Jose Angel Garcia Saenz
        • Contact:
          • Phone Number: 34913303000 ext 7768
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Hospital Universitario HM Sanchinarro
        • Principal Investigator:
          • Ana Luna Barrera
      • Madrid, Spain, 28009
        • Not yet recruiting
        • Hospital General Universitario Gregorio Marañon
        • Principal Investigator:
          • Francisco Ayala
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Hospital Beata Maria Ana
        • Principal Investigator:
          • Lucia Sanz Gomez
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Universitario Virgen de la Victoria
        • Principal Investigator:
          • Emilio Alba Conejo
        • Contact:
          • Phone Number: 94951032508
      • Palma, Spain, 07120
        • Not yet recruiting
        • Hospital Universitari Son Espases
        • Principal Investigator:
          • Antonia Perello Martorell
        • Contact:
          • Phone Number: 34 871 206 130
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Principal Investigator:
          • Cesar Rodriguez
      • San Cristóbal de La Laguna, Spain, 38320
        • Not yet recruiting
        • Hospital Universitario de Canarias
        • Principal Investigator:
          • Josefina Cruz Jurado
        • Contact:
          • Phone Number: 922677351
      • Santiago de Compostela, Spain, 15706
        • Not yet recruiting
        • CHUS - Hospital Clinico Universitario
        • Contact:
          • Phone Number: 981950511
        • Principal Investigator:
          • Rafael Lopez Lopez
      • Seville, Spain, 41009
        • Not yet recruiting
        • Hospital Universitario Virgen Macarena
        • Principal Investigator:
          • Fernando Henao Carrasco
      • Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Manuel Ruiz Borrego
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico de Valencia
        • Principal Investigator:
          • Begona Bermejo de las Heras
        • Contact:
          • Phone Number: 34961973583
      • Valencia, Spain, 46009
        • Not yet recruiting
        • Fundación Instituto Valenciano de Oncología
        • Principal Investigator:
          • Cristina Hernando Melia
        • Contact:
          • Phone Number: 651056277
      • Valencia, Spain, 46015
        • Not yet recruiting
        • Hospital Arnau De Vilanova
        • Principal Investigator:
          • Antonio Llombart Cussac
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Principal Investigator:
          • Raquel Andres
        • Contact:
          • Phone Number: 34 976 76 57 46
  • Taiwan
      • Taichung, Taiwan, 407
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Principal Investigator:
          • Chih-Chiang Hung
        • Contact:
          • Phone Number: 886-42359-2525-5031
      • Tainan, Taiwan, 704
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • Wei-Pang Chung
        • Contact:
          • Phone Number: 886-6-2353535 x4620
      • Tainan, Taiwan, 71004
        • Not yet recruiting
        • Chi Mei Medical Center
        • Principal Investigator:
          • Yu-Hsuan Kuo
      • Taipei, Taiwan, 11217
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Ling-Ming Tseng
        • Contact:
          • Phone Number: 886228712121
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Yen-Shen Lu
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01370
        • Not yet recruiting
        • Adana City Hospital
        • Principal Investigator:
          • Timucin Cil
        • Contact:
          • Phone Number: 90538 609 92 02
      • Adana, Turkey (Türkiye), 01250
        • Not yet recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center
        • Contact:
          • Phone Number: 905353067506
        • Principal Investigator:
          • Ozgur Ozyilkan
      • Ankara, Turkey (Türkiye), 06200
        • Not yet recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
        • Principal Investigator:
          • Ozturk Ates
      • Ankara, Turkey (Türkiye), 06620
        • Not yet recruiting
        • Ankara University Health Practice and Research Hospitals
        • Contact:
          • Phone Number: 00903125957321
        • Principal Investigator:
          • Yuksel Urun
      • Bornova, Turkey (Türkiye), 35100
        • Not yet recruiting
        • Ege Universitesi Hastanesi
        • Contact:
          • Phone Number: 905337360674
        • Principal Investigator:
          • Erhan Gokmen
      • Edirne, Turkey (Türkiye), 22030
        • Not yet recruiting
        • Trakya University
        • Principal Investigator:
          • Sernaz Topaloglu
        • Contact:
          • Phone Number: 905326845953
      • Istanbul, Turkey (Türkiye), 34010
        • Not yet recruiting
        • Koc Universitesi Hastanesi
        • Principal Investigator:
          • Fatih Selcukbiricik
      • Istanbul, Turkey (Türkiye), 34718
        • Not yet recruiting
        • Yeditepe Universitesi Kosuyolu Hastanesi
        • Principal Investigator:
          • Serkan Celik
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Not yet recruiting
        • Western General Hospital
        • Contact:
          • Phone Number: 01316518709
        • Principal Investigator:
          • Olga Oikonomidou
      • Huddersfield, United Kingdom, HD3 3EA
        • Not yet recruiting
        • Huddersfield Royal Infirmary
        • Principal Investigator:
          • Heeranand Keswani
      • London, United Kingdom, EC1A 7BE
        • Not yet recruiting
        • St Bartholomew's Hospital
        • Principal Investigator:
          • Peter Schmid
        • Contact:
          • Phone Number: 02078828494
      • London, United Kingdom, SM2 5PT
        • Not yet recruiting
        • Royal Marsden Hospital (Sutton)
        • Principal Investigator:
          • Emma Kipps
      • London, United Kingdom, SW3 6JJ
        • Not yet recruiting
        • Royal Marsden Hospital (Chelsea)
        • Principal Investigator:
          • Emma Kipps
      • Manchester, United Kingdom, M20 4BX
        • Not yet recruiting
        • The Christie NHS Foundation Trust
        • Principal Investigator:
          • sacha howell
      • Plymouth, United Kingdom, Pl6 8DH
        • Not yet recruiting
        • Derriford Hospital
        • Principal Investigator:
          • Udaiveer Panwar
      • Worcester, United Kingdom, WR5 1DD
        • Not yet recruiting
        • Worcestershire Royal Hospital
        • Principal Investigator:
          • Subhadeep Bose
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Not yet recruiting
        • Alaska Oncology and Hematology
        • Principal Investigator:
          • Steven Liu
        • Contact:
          • Phone Number: 907-257-9851
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Not yet recruiting
        • Ironwood Cancer & Research Centers
        • Principal Investigator:
          • Jasleen Khanuja
      • Phoenix, Arizona, United States, 85054
        • Not yet recruiting
        • Mayo Clinic in Arizona - Phoenix
        • Contact:
          • Phone Number: 480-301-8000
        • Principal Investigator:
          • Shakeela Bahadur
      • Tucson, Arizona, United States, 85719
        • Not yet recruiting
        • The University of Arizona Cancer Center - North Campus
        • Principal Investigator:
          • Sima Ehsani
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Not yet recruiting
        • Genesis Cancer and Blood Institute
        • Contact:
          • Phone Number: 501-624-7700
        • Principal Investigator:
          • Stephen Divers
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
        • Principal Investigator:
          • Joseph Beck
        • Contact:
          • Phone Number: 479-872-8130
    • California
      • Clovis, California, United States, 93611
        • Not yet recruiting
        • Community Cancer Institute
        • Principal Investigator:
          • Li Ge
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope
        • Principal Investigator:
          • Hope Rugo
      • Greenbrae, California, United States, 94904
        • Recruiting
        • Marin Cancer Care
        • Principal Investigator:
          • Cyrus Mazidi
      • Irvine, California, United States, 92618
        • Not yet recruiting
        • City of Hope Orange County Lennar Foundation Cancer Center
        • Principal Investigator:
          • Hope Rugo
      • Irvine, California, United States, 92612
        • Not yet recruiting
        • Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
        • Principal Investigator:
          • Ritesh Parajuli
        • Contact:
          • Phone Number: 714-456-8614
      • La Jolla, California, United States, 92093
        • Not yet recruiting
        • Moores Cancer Center
        • Principal Investigator:
          • Xiaojie Zhang
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • USC/Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Daphne Stewart
        • Contact:
          • Phone Number: 323-397-5954
      • Newport Beach, California, United States, 92663
        • Not yet recruiting
        • Hoag Memorial Hospital Presbyterian
        • Principal Investigator:
          • Chaitali Nangia
      • Oakland, California, United States, 94611
        • Not yet recruiting
        • Kaiser Permanente Oakland
        • Principal Investigator:
          • Jennifer Suga
        • Contact:
          • Phone Number: 707-651-5213
      • Oceanside, California, United States, 92056
        • Not yet recruiting
        • Profound Research LLC
        • Principal Investigator:
          • Catherine Quinn
      • Orange, California, United States, 92868
        • Not yet recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center
        • Principal Investigator:
          • Ritesh Parajuli
        • Contact:
          • Phone Number: 714-456-8614
      • Palm Springs, California, United States, 92262
        • Not yet recruiting
        • Desert Regional Medical Center
        • Contact:
          • Phone Number: 760-416-4749
        • Principal Investigator:
          • Kim Phan
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Stanford Cancer Center
        • Principal Investigator:
          • Fauzia Riaz
      • Roseville, California, United States, 95661
        • Not yet recruiting
        • Kaiser Permanente
        • Principal Investigator:
          • Jennifer Suga
      • San Francisco, California, United States, 94158
        • Suspended
        • UCSF Medical Center at Mission Bay
      • San Francisco, California, United States, 94115
        • Not yet recruiting
        • Kaiser Permanente
        • Principal Investigator:
          • Jennifer Suga
        • Contact:
          • Phone Number: 707-651-5213
      • Santa Clara, California, United States, 95051
        • Not yet recruiting
        • Kaiser Permanente
        • Principal Investigator:
          • Jennifer Suga
      • Santa Monica, California, United States, 90404
        • Not yet recruiting
        • UCLA Hematology/Oncology - Parkside
        • Contact:
          • Phone Number: 310-998-4747
        • Principal Investigator:
          • Nicholas McAndrew
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Ian Anderson
      • Vallejo, California, United States, 94589
        • Not yet recruiting
        • Kaiser Permanente
        • Principal Investigator:
          • Jennifer Suga
      • Walnut Creek, California, United States, 94596
        • Not yet recruiting
        • Kaiser Permanente Walnut Creek
        • Principal Investigator:
          • Jennifer Suga
        • Contact:
          • Phone Number: 707-651-2797
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Not yet recruiting
        • Cancer Centers of Colorado St. Mary's Regional Hospital
        • Principal Investigator:
          • Alicia Swink
        • Contact:
          • Phone Number: 970-298-7500
      • Greeley, Colorado, United States, 80631
        • Not yet recruiting
        • Banner MD Anderson Cancer Center at North Colorado Medical Center
        • Principal Investigator:
          • Esther Mondo
        • Contact:
          • Phone Number: 970-810-3894
      • Loveland, Colorado, United States, 80538
        • Not yet recruiting
        • Banner MD Anderson Cancer Center at McKee Medical Center
        • Principal Investigator:
          • Esther Mondo
        • Contact:
          • Phone Number: 970-810-3894
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Not yet recruiting
        • MedStar Washington Hospital Center
        • Principal Investigator:
          • Ami Chitalia
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Not yet recruiting
        • AdventHealth Altamonte Springs
        • Principal Investigator:
          • Wassim Mchayleh
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Clermont Oncology Center
        • Contact:
          • Phone Number: 352-242-1366
        • Principal Investigator:
          • Gopal Kunta
      • Fort Myers, Florida, United States, 33912
        • Not yet recruiting
        • Florida Oncology & Hematology
        • Contact:
          • Phone Number: 239-264-7026
        • Principal Investigator:
          • Venkata Parsa
      • Jacksonville, Florida, United States, 32224
        • Not yet recruiting
        • Mayo Clinic in Florida
        • Contact:
          • Phone Number: 904-953-2000
        • Principal Investigator:
          • Rishitha Bollam
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center
        • Principal Investigator:
          • Frances Valdes
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center
        • Contact:
          • Phone Number: 386-774-1223
        • Principal Investigator:
          • Santosh Nair
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
        • Principal Investigator:
          • Aixa Soyano
    • Georgia
      • Macon, Georgia, United States, 31210
        • Not yet recruiting
        • Central Georgia Cancer Care
        • Contact:
          • Phone Number: 478-336-5708
        • Principal Investigator:
          • Bradley Sumrall
      • Newnan, Georgia, United States, 30265
        • Not yet recruiting
        • City of Hope National Medical Center, Atlanta Cancer Center
        • Principal Investigator:
          • Sarah Friend
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Summit Cancer Care, PC
        • Principal Investigator:
          • Alison Spellman
        • Contact:
          • Phone Number: 912-651-5771
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Not yet recruiting
        • Kaiser Permanente Moanalua Medical Center
        • Principal Investigator:
          • Jennifer Carney
        • Contact:
          • Phone Number: 808-432-8000
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • University of Illinois at Chicago
        • Contact:
          • Phone Number: 312-996-1581
        • Principal Investigator:
          • Vijayakrishna Gadi
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern Memorial Hospital
        • Principal Investigator:
          • William Gradishar
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • City of Hope, Chicago
        • Principal Investigator:
          • Ajaz M. Khan
      • Lisle, Illinois, United States, 60532
        • Not yet recruiting
        • Accellacare of Duly
        • Principal Investigator:
          • Daniel Frank
      • Springfield, Illinois, United States, 62702
        • Not yet recruiting
        • Simmons Cancer Institute at SIU
        • Contact:
          • Phone Number: 217-545-8000
        • Principal Investigator:
          • Krishna Rao
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital
        • Principal Investigator:
          • Tarah Ballinger
      • Newburgh, Indiana, United States, 47630
        • Not yet recruiting
        • Deaconess Chancellor Center for Oncology
        • Principal Investigator:
          • Karim Anwar
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
        • Principal Investigator:
          • Mark Burkard
        • Contact:
          • Phone Number: 319-353-6665
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Not yet recruiting
        • Saint Elizabeth Medical Center Edgewood
        • Principal Investigator:
          • Matthew Kurian
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Not yet recruiting
        • Our Lady of the Lake RMC
        • Principal Investigator:
          • Marshall Stagg
    • Maine
      • Westbrook, Maine, United States, 04092
        • Not yet recruiting
        • New England Cancer Specialists
        • Principal Investigator:
          • Eleni Nackos
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Not yet recruiting
        • American Oncology Partners, PA
        • Contact:
          • Phone Number: 301-571-2016
        • Principal Investigator:
          • Victor Priego
      • Frederick, Maryland, United States, 21702
        • Not yet recruiting
        • James M Stockman Cancer Institute
        • Principal Investigator:
          • Natalia Marina
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Antonio Giordano
        • Contact:
          • Phone Number: 617-632-3800
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Mass General Cancer Center
        • Principal Investigator:
          • Dejan Juric
      • Milford, Massachusetts, United States, 01757
        • Not yet recruiting
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
        • Principal Investigator:
          • Natalie Sinclair
        • Contact:
          • Phone Number: 508-488-3700
      • South Weymouth, Massachusetts, United States, 02190
        • Not yet recruiting
        • Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital
        • Principal Investigator:
          • James Stoeckle
      • Worcester, Massachusetts, United States, 01655
        • Not yet recruiting
        • University of Massachusetts Medical School
        • Contact:
          • Phone Number: 508-856-3216
        • Principal Investigator:
          • Madhavi Toke
    • Michigan
      • Sterling Heights, Michigan, United States, 48314
        • Not yet recruiting
        • Profound Research LLC
        • Principal Investigator:
          • Laura Kohler
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic in Rochester, Minnesota
        • Contact:
          • Phone Number: 507-284-2511
        • Principal Investigator:
          • Matthew Goetz
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Not yet recruiting
        • North Mississippi Hematology and Oncology Associates
        • Principal Investigator:
          • Rana Usman
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Not yet recruiting
        • Saint Luke's Cancer Institute
        • Principal Investigator:
          • Timothy Pluard
        • Contact:
          • Phone Number: 816-932-2677
      • Springfield, Missouri, United States, 65807
        • Not yet recruiting
        • Oncology Hematology Associates
        • Contact:
          • Phone Number: 417-882-4880
        • Principal Investigator:
          • Viran Holden
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Not yet recruiting
        • Dartmouth-Hitchcock Medical Center
        • Principal Investigator:
          • Muhammad Afzal
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • Jefferson Health - Cherry Hill
        • Principal Investigator:
          • Steven Manobianco
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Sidney Kimmel Cancer Center - Washington Township
        • Principal Investigator:
          • Steven Manobianco
      • Summit, New Jersey, United States, 07901
        • Not yet recruiting
        • Atlantic Health System Overlook Medical Center
        • Principal Investigator:
          • Bonni Guerin
    • New York
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Komal Jhaveri
        • Contact:
          • Phone Number: 646-888-5157
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Not yet recruiting
        • Messino Cancer Centers
        • Principal Investigator:
          • Rachel Raab
      • Cary, North Carolina, United States, 27518
        • Not yet recruiting
        • WakeMed Cancer Care - Waverly Hematology & Medical Oncology
        • Principal Investigator:
          • Pallavi Kopparthy
        • Contact:
          • Phone Number: 919-350-2873
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • University of North Carolina Medical Center
        • Contact:
          • Phone Number: 919-260-4616
        • Principal Investigator:
          • Elizabeth Dees
      • Wilson, North Carolina, United States, 27893
        • Not yet recruiting
        • Carolina Cancer Research Center
        • Principal Investigator:
          • Keith Lerro
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Not yet recruiting
        • Sanford Fargo Medical Center
        • Principal Investigator:
          • Anu Gaba
    • Ohio
      • Akron, Ohio, United States, 44302
        • Not yet recruiting
        • Cleveland Clinic Akron General
        • Contact:
          • Phone Number: 330-888-4000
        • Principal Investigator:
          • Daniel Silbiger
      • Canton, Ohio, United States, 44718
        • Not yet recruiting
        • Gabrail Cancer Center
        • Principal Investigator:
          • Nashat Gabrail
        • Contact:
          • Phone Number: 330-492-3345
      • Cleveland, Ohio, United States, 44111
        • Not yet recruiting
        • Fairview Hospital
        • Contact:
          • Phone Number: 330-888-4000
        • Principal Investigator:
          • Daniel Silbiger
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
        • Contact:
          • Phone Number: 614-366-1525
        • Principal Investigator:
          • Robert Wesolowski
      • Mayfield Heights, Ohio, United States, 44124
        • Not yet recruiting
        • Cleveland Clinic - Hillcrest Hospital
        • Contact:
          • Phone Number: 330-888-4000
        • Principal Investigator:
          • Daniel Silbiger
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Good Samaritan Regional Medical Center
        • Principal Investigator:
          • John Strother
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon
        • Principal Investigator:
          • Miho Dougherty
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health and Science University
        • Contact:
          • Phone Number: 971-262-9600
        • Principal Investigator:
          • Annie Hung
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Not yet recruiting
        • St. Luke's University Health Network
        • Principal Investigator:
          • Maria Hafez
      • Lancaster, Pennsylvania, United States, 17601
        • Not yet recruiting
        • Lancaster General Hospital - Ann B Barshinger Cancer Institute
        • Principal Investigator:
          • Amy Clark
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Clinical Research Institute
        • Principal Investigator:
          • Steven Manobianco
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • University of Pennsylvania Hospital
        • Principal Investigator:
          • Amy Clark
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Jefferson Hospital Northeast
        • Principal Investigator:
          • Steven Manobianco
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Principal Investigator:
          • Steven Manobianco
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Abirami Sivapiragasam
        • Contact:
          • Phone Number: 843-792-9300
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute SCRI
        • Principal Investigator:
          • SMO Sarah Cannon Research Inst.
      • Nashville, Tennessee, United States, 37208
        • Not yet recruiting
        • Nashville General Hospital
        • Contact:
          • Phone Number: 615-341-4383
        • Principal Investigator:
          • Robin Jacob
    • Texas
      • Abilene, Texas, United States, 79601
        • Not yet recruiting
        • Hendrick Medical Center
        • Contact:
          • Phone Number: 325-670-7724
        • Principal Investigator:
          • Jose Velasco Di Domenico
      • Baytown, Texas, United States, 77521
        • Recruiting
        • World Research Link
        • Contact:
          • Phone Number: 833-832-8328
        • Principal Investigator:
          • Amir Rasheed
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Phone Number: 214-648-4180
        • Principal Investigator:
          • Nisha Unni
      • Dallas, Texas, United States, 75235
        • Not yet recruiting
        • Parkland Health and Hospital System
        • Contact:
          • Phone Number: 214-648-4180
        • Principal Investigator:
          • Nisha Unni
      • Dallas, Texas, United States, 75246
        • Recruiting
        • USO - Texas Oncology
        • Principal Investigator:
          • Joyce O'Shaughnessy
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Texas Oncology - West Texas
        • Principal Investigator:
          • Ines Sanchez
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Hanh Mai
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants P.A.
        • Principal Investigator:
          • Ricardo Alvarez
        • Contact:
          • Phone Number: 713-600-0900
      • Houston, Texas, United States, 77030-4009
        • Not yet recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
          • Phone Number: 832-728-7423
        • Principal Investigator:
          • Senthil Damodaran
      • McAllen, Texas, United States, 78504
        • Recruiting
        • Nova Oncology
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Raghad Muhsin Abdul Karim, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio Medical Center
        • Principal Investigator:
          • Emmalind Aponte
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • US Oncology Research Network
        • Principal Investigator:
          • SMO Sarah Cannon Research Inst.
      • Webster, Texas, United States, 77598
        • Not yet recruiting
        • Tranquility Research
        • Principal Investigator:
          • John Knecht
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Not yet recruiting
        • Utah Cancer Specialists
        • Principal Investigator:
          • Stephan Kendall
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Not yet recruiting
        • The University of Vermont Medical Center Inc.
        • Principal Investigator:
          • Peter Kaufman
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Virginia Cancer Specialists
        • Principal Investigator:
          • Shruti Tiwari
    • Washington
      • Edmonds, Washington, United States, 98026
        • Not yet recruiting
        • Swedish Cancer Institute - Edmonds
        • Principal Investigator:
          • Michaela Tsai
      • Everett, Washington, United States, 98201
        • Not yet recruiting
        • Providence Regional Cancer Partnership
        • Principal Investigator:
          • Xiaowen Wang
      • Renton, Washington, United States, 98055
        • Not yet recruiting
        • UW Medicine Valley Medical Center
        • Principal Investigator:
          • Navanshu Arora
        • Contact:
          • Phone Number: 425-690-3503
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • Swedish Medical Center
        • Principal Investigator:
          • Michaela Tsai
      • Spokane, Washington, United States, 99204
        • Not yet recruiting
        • Deaconess Hospital
        • Principal Investigator:
          • Blair Irwin
      • Spokane Valley, Washington, United States, 99216
        • Not yet recruiting
        • Cancer Care Northwest - Vercler
        • Principal Investigator:
          • Saritha Thumma
      • Tacoma, Washington, United States, 98405
        • Not yet recruiting
        • MultiCare Health System
        • Principal Investigator:
          • Blair Irwin
      • Yakima, Washington, United States, 98902
        • Not yet recruiting
        • North Star Lodge
        • Principal Investigator:
          • Blair Irwin
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Not yet recruiting
        • ThedaCare Physicians - Appleton North
        • Principal Investigator:
          • Shannon Schmidt
        • Contact:
          • Phone Number: 920-364-3600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: Palbociclib
Administered orally
Drug: Anastrozole
Administered orally
Drug: Letrozole
Administered orally
Drug: LY4064809
Administered orally
Other Names:
  • STX-478
  • Tersolisib
Drug: Ribociclib
Administered orally
Drug: Exemestane
Administered orally
Drug: Fulvestrant
Administered intramuscular
Experimental: 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: Palbociclib
Administered orally
Drug: Anastrozole
Administered orally
Drug: Letrozole
Administered orally
Drug: LY4064809
Administered orally
Other Names:
  • STX-478
  • Tersolisib
Drug: Exemestane
Administered orally
Drug: Fulvestrant
Administered intramuscular
Placebo Comparator: 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
Drug: Palbociclib
Administered orally
Drug: Anastrozole
Administered orally
Drug: Letrozole
Administered orally
Drug: Exemestane
Administered orally
Drug: Fulvestrant
Administered intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)
Time Frame: Baseline through disease progression or death (Estimated up to 5 years)
As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Baseline through disease progression or death (Estimated up to 5 years)
(Part 2): Progression-Free Survival
Time Frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)
Investigator-assessed
Baseline to objective progression or death due to any cause (Estimated up to 5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Part 1): Disease Control Rate (DCR)
Time Frame: Baseline through measured progressive disease (Estimated up to 5 years)
per RECIST v1.1
Baseline through measured progressive disease (Estimated up to 5 years)
(Part 1): Time to Response (TTR)
Time Frame: Baseline until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 5 years)
per RECIST v1.1
Baseline until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 5 years)
(Parts 1 and 2): Duration of Response (DOR)
Time Frame: Date of CR or PR to date of objective disease progression or death due to any cause (Estimated up to 5 years)
per RECIST v1.1
Date of CR or PR to date of objective disease progression or death due to any cause (Estimated up to 5 years)
(Part 1): PFS
Time Frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)
per RECIST v1.1
Baseline to objective progression or death due to any cause (Estimated up to 5 years)
(Parts 1 and 2): Overall Survival (OS)
Time Frame: Baseline to deaths from any cause (Estimated up to 7 years)
Baseline to deaths from any cause (Estimated up to 7 years)
(Part 1): Best Overall Response (BOR)
Time Frame: Baseline to disease progression or death from any cause (Estimated up to 5 years)
Baseline to disease progression or death from any cause (Estimated up to 5 years)
(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
Time Frame: Baseline to disease progression or death from any cause (Estimated up to 5 years)
per RECIST v1.1
Baseline to disease progression or death from any cause (Estimated up to 5 years)
(Parts 1 and 2): PK: Average Plasma Concentrations of LY4064809
Time Frame: Baseline to last PK sample collection up to 5 months
Baseline to last PK sample collection up to 5 months
(Part 2): Progression-Free Survival after Subsequent Line of Treatment (PFS2)
Time Frame: Baseline to disease progression on next line of treatment or death from any cause (Estimated as up to 7 years)
Investigator-assessed
Baseline to disease progression on next line of treatment or death from any cause (Estimated as up to 7 years)
(Part 2): Progression-Free Survival (PFS)
Time Frame: Baseline to objective progression or death from any cause (Estimated up to 5 years)
By BICR
Baseline to objective progression or death from any cause (Estimated up to 5 years)
(Part 2): Objective Response Rate (ORR)
Time Frame: Baseline to disease progression or death from any cause (Estimated up to 5 years)
By investigator and blinded independent central review (BICR)
Baseline to disease progression or death from any cause (Estimated up to 5 years)
(Part 2): Time to Chemotherapy (TTC)
Time Frame: Baseline until the start of chemotherapy (Estimated up to 7 years)
Baseline until the start of chemotherapy (Estimated up to 7 years)
(Part 2): Chemotherapy-Free Survival
Time Frame: Baseline until the start of chemotherapy or death from any cause (Estimated up to 7 years)
Baseline until the start of chemotherapy or death from any cause (Estimated up to 7 years)
(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
Time Frame: Baseline until disease progression or death (Estimated up to 7 years)
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.
Baseline until disease progression or death (Estimated up to 7 years)
(Part 2): Change in Physical Function as measured by the EORTC QLQ-C30 Physical Functioning Subscale
Time Frame: Baseline until disease progression or death (Estimated up to 7 years)
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.
Baseline until disease progression or death (Estimated up to 7 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Pfizer

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2033

Study Registration Dates

First Submitted

September 12, 2025

First Submitted That Met QC Criteria

September 12, 2025

First Posted (Actual)

September 15, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27726
  • J6M-MC-JSGD (Other Identifier: Eli Lilly and Company)
  • 2025-522791-92-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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