Breast NeoplasmsPhase 3NCT07174336
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
A Phase 3 study testing LY4064809, Ribociclib and Palbociclib in people with Breast Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 363 sites in 19 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- What is being tested?
- LY4064809, Ribociclib and Palbociclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 363 sitesin 19 countries
- Study dates
- 22 Dec 2025to May 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 trials.
- 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
Show all 23Show fewer
- 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)
- participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET
- 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.
Who cannot join
- 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.
- Have active bacterial or fungal infection that is not recovered at randomization.
Trial locations and contacts
363 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
363 sites in 19 countries
United States129 sites, 128 recruiting
- Not yet recruiting
Hendrick Medical Center
Abilene, Texas, 79601
325-670-7724
Jose Velasco Di Domenico
- Not yet recruiting
Cleveland Clinic Akron General
Akron, Ohio, 44302
330-888-4000
Daniel Silbiger
- Not yet recruiting
NYOH Albany Cancer Center
Albany, New York, 12206
Ami Negandhi
- Not yet recruiting
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701
Wassim Mchayleh
- Not yet recruiting
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
907-257-9851
Steven Liu
- Recruiting
ThedaCare Physicians - Appleton North
Appleton, Wisconsin, 54911
920-364-3600
Shannon Schmidt
- Recruiting
Messino Cancer Centers
Asheville, North Carolina, 28806
Rachel Raab
- Not yet recruiting
Our Lady of the Lake RMC
Baton Rouge, Louisiana, 70808
Marshall Stagg
- Recruiting
World Research Link
Baytown, Texas, 77521
833-832-8328
Amir Rasheed
- Recruiting
American Oncology Partners, PA
Bethesda, Maryland, 20817
301-571-2016
Victor Priego
- Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Maria Hafez
- Not yet recruiting
Mass General Cancer Center
Boston, Massachusetts, 02114
Dejan Juric
- Not yet recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
617-632-3800
Antonio Giordano
- Not yet recruiting
New York University (NYU) Brooklyn
Brooklyn, New York, 11220
Nina D'abreo
- Not yet recruiting
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05401
Peter Kaufman
- Not yet recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
330-492-3345
Nashat Gabrail
- Not yet recruiting
WakeMed Cancer Care - Waverly Hematology & Medical Oncology
Cary, North Carolina, 27518
919-350-2873
Pallavi Kopparthy
- Recruiting
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Jasleen Khanuja
- Not yet recruiting
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
919-260-4616
Elizabeth Dees
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
843-792-9300
Abirami Sivapiragasam
- Recruiting
Jefferson Health - Cherry Hill
Cherry Hill, New Jersey, 08002
Steven Manobianco
- Recruiting
City of Hope, Chicago
Chicago, Illinois, 60611
Teja Poosarla
- Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
William Gradishar
- Not yet recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Oana Danciu
- Recruiting
Clermont Oncology Center
Clermont, Florida, 34711
352-242-1366
Gopal Kunta
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Alberto Montero
- Not yet recruiting
Fairview Hospital
Cleveland, Ohio, 44111
330-888-4000
Daniel Silbiger
- Not yet recruiting
Community Cancer Institute
Clovis, California, 93611
Li Ge
- Not yet recruiting
Piedmont Columbus Regional - John B. Amos Cancer Center
Columbus, Georgia, 31904
706-478-7968
Andrew Pippas
- Not yet recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210
614-366-1525
Robert Wesolowski
- Recruiting
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
John Strother
- Not yet recruiting
Parkland Health and Hospital System
Dallas, Texas, 75235
214-648-4180
Nisha Unni
- Recruiting
USO - Texas Oncology
Dallas, Texas, 75246
Joyce O'Shaughnessy
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
214-648-4180
Nisha Unni
- Recruiting
City of Hope
Duarte, California, 91010
Hope Rugo
- Recruiting
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, 41017
Matthew Kurian
- Not yet recruiting
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Michaela Tsai
- Recruiting
Texas Oncology - West Texas
El Paso, Texas, 79902
Ines Sanchez
- Recruiting
Epic Care - Emeryville
Emeryville, California, 94608
srikanth reddy
- Recruiting
Oncology Associates of Oregon
Eugene, Oregon, 97401
Miho Dougherty
- Not yet recruiting
Endeavor Health
Evanston, Illinois, 60201
Poornima Saha
- Not yet recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Xiaowen Wang
- Not yet recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Shruti Tiwari
- Not yet recruiting
Sanford Fargo Medical Center
Fargo, North Dakota, 58102
Anu Gaba
- Not yet recruiting
UConn Health
Farmington, Connecticut, 06030-8010
Yueming Chang
- Not yet recruiting
UCHealth Harmony
Fort Collins, Colorado, 80528
970-493-6337
Chelsea Gawryletz
- Recruiting
Florida Oncology & Hematology
Fort Myers, Florida, 33912
239-264-7026
Venkata Parsa
- Recruiting
James M Stockman Cancer Institute
Frederick, Maryland, 21702
Natalia Marina
- Not yet recruiting
Cancer Centers of Colorado St. Mary's Regional Hospital
Grand Junction, Colorado, 81501
970-298-7500
Alicia Swink
- Not yet recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, 80631
970-810-3894
Esther Mondo
- Recruiting
Marin Cancer Care
Greenbrae, California, 94904
Cyrus Mazidi
- Not yet recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
808-432-8000
Jennifer Carney
- Not yet recruiting
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913
501-624-7700
Stephen Divers
- Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
832-728-7423
Senthil Damodaran
- Not yet recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Hanh Mai
- Recruiting
Oncology Consultants P.A.
Houston, Texas, 77030
713-600-0900
Ricardo Alvarez
- Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Tarah Ballinger
- Not yet recruiting
Hematology Oncology of Indiana
Indianapolis, Indiana, 46260
317-297-2208
Ruemu Birhiray
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
319-353-6665
Mark Burkard
- Not yet recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
Irvine, California, 92612
714-456-8614
Ritesh Parajuli
- Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Hope Rugo
- Not yet recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
904-953-2000
Rishitha Bollam
- Not yet recruiting
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
816-932-2677
Timothy Pluard
- Not yet recruiting
Moores Cancer Center
La Jolla, California, 92093
Xiaojie Zhang
- Not yet recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601
Amy Clark
- Not yet recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Muhammad Afzal
- Recruiting
Accellacare of Duly
Lisle, Illinois, 60532
Daniel Frank
- Not yet recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
323-397-5954
Daphne Stewart
- Not yet recruiting
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, Colorado, 80538
970-810-3894
Esther Mondo
- Recruiting
Central Georgia Cancer Care
Macon, Georgia, 31210
478-336-5708
Bradley Sumrall
- Not yet recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
330-888-4000
Daniel Silbiger
- Recruiting
Nova Oncology
McAllen, Texas, 78504
956-234-4400
Raghad Muhsin Abdul Karim, MD
- Not yet recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
Frances Valdes
- Not yet recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
612-863-8716
Amy Krie
- Recruiting
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203
SMO Sarah Cannon Research Inst.
- Recruiting
Nashville General Hospital
Nashville, Tennessee, 37208
615-341-4383
Robin Jacob
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
646-888-5157
Komal Jhaveri
- Not yet recruiting
NYC Health + Hospitals / Bellevue
New York, New York, 11106
Nina D'abreo
- Not yet recruiting
Deaconess GI Specialty Center
Newburgh, Indiana, 47630
Karim Anwar
- Recruiting
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, 30265
Sarah Friend
- Not yet recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Chaitali Nangia
- Not yet recruiting
Kaiser Permanente Oakland
Oakland, California, 94611
707-651-5213
Jennifer Suga
- Recruiting
Profound Research LLC
Oceanside, California, 92056
Catherine Quinn
- Not yet recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
714-456-8614
Ritesh Parajuli
- Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
386-774-1223
Santosh Nair
- Not yet recruiting
Desert Regional Medical Center
Palm Springs, California, 92262
760-416-4749
Kim Phan
- Not yet recruiting
Stanford Cancer Center
Palo Alto, California, 94304
Fauzia Riaz
- Not yet recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Amy Clark
- Recruiting
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
Steven Manobianco
- Recruiting
Jefferson Hospital Northeast
Philadelphia, Pennsylvania, 19114
Steven Manobianco
- Not yet recruiting
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85004
602-406-8831
Albert Wendt
- Not yet recruiting
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
480-301-8000
Shakeela Bahadur
- Not yet recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Aimee Kohn
- Recruiting
UW Medicine Valley Medical Center
Renton, Washington, 98055
425-690-3503
Navanshu Arora
- Not yet recruiting
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
507-284-2511
Matthew Goetz
- Not yet recruiting
Kaiser Permanente
Roseville, California, 95661
Jennifer Suga
- Not yet recruiting
Metro-Minnesota Community Clinical Oncology
Saint Louis Park, Minnesota, 55426
651-254-3572
Yan Ji
- Not yet recruiting
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Stephan Kendall
- Recruiting
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240
Emmalind Aponte
- Not yet recruiting
Kaiser Permanente
San Francisco, California, 94115
707-651-5213
Jennifer Suga
- Not yet recruiting
Kaiser Permanente
Santa Clara, California, 95051
Jennifer Suga
- Not yet recruiting
UCLA Hematology/Oncology - Parkside
Santa Monica, California, 90404
310-998-4747
Nicholas McAndrew
- Recruiting
Providence Medical Foundation
Santa Rosa, California, 95403
Ian Anderson
- Not yet recruiting
Low Country Cancer Care
Savannah, Georgia, 31404
912-692-2000
Jennifer Yannucci
- Recruiting
Summit Cancer Care, PC
Savannah, Georgia, 31405
912-651-5771
Alison Spellman
- Not yet recruiting
Swedish Medical Center
Seattle, Washington, 98104
Michaela Tsai
- Recruiting
Sidney Kimmel Cancer Center - Washington Township
Sewell, New Jersey, 08080
Steven Manobianco
- Not yet recruiting
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Allison Watson
- Recruiting
Deaconess Hospital
Spokane, Washington, 99204
Blair Irwin
- Not yet recruiting
Cancer Care Northwest - Vercler
Spokane Valley, Washington, 99216
Saritha Thumma
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
479-872-8130
Joseph Beck
- Not yet recruiting
Simmons Cancer Institute at SIU
Springfield, Illinois, 62702
217-545-8000
Krishna Rao
- Recruiting
Oncology Hematology Associates
Springfield, Missouri, 65807
417-882-4880
Viran Holden
- Suspended
Profound Research LLC
Sterling Heights, Michigan, 48314
- Recruiting
Atlantic Health System Overlook Medical Center
Summit, New Jersey, 07901
Bonni Guerin
- Recruiting
MultiCare Health System
Tacoma, Washington, 98405
Blair Irwin
- Not yet recruiting
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612
Aixa Soyano
- Recruiting
US Oncology Research Network
The Woodlands, Texas, 77380
SMO Sarah Cannon Research Inst.
- Recruiting
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
Sima Ehsani
- Recruiting
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, 38801
Rana Usman
- Not yet recruiting
Kaiser Permanente
Vallejo, California, 94589
707-651-2797
Jennifer Suga
- Not yet recruiting
Kaiser Permanente Walnut Creek
Walnut Creek, California, 94596
707-651-2797
Jennifer Suga
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Ami Chitalia
- Recruiting
Tranquility Research
Webster, Texas, 77598
John Knecht
- Not yet recruiting
New England Cancer Specialists
Westbrook, Maine, 04092
Eleni Nackos
- Recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Steven Manobianco
- Recruiting
Carolina Cancer Research Center
Wilson, North Carolina, 27893
Keith Lerro
- Not yet recruiting
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
508-856-3216
Madhavi Toke
- Recruiting
North Star Lodge
Yakima, Washington, 98902
Blair Irwin
Spain28 sites, 28 recruiting
- Not yet recruiting
Hospital Infanta Cristina
Badajoz, 06006
+34924218040
JUAN IGNACIO DELGADO MINGORANCE
- Not yet recruiting
Hospital Universitari Dexeus
Barcelona, 08028
34935460139
Alejandro Martínez Bueno
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
+34 93 274 60 00
Cristina Saura
- Not yet recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Raquel Gómez Bravo
- Not yet recruiting
Hospital San Pedro de Alcántara
Cáceres, 10003
34927621612
Santiago Gonzalez Santiago
- Not yet recruiting
Hospital Universitario Donostia
Donostia / San Sebastian, 20014
Maria Ariño
- Not yet recruiting
Hospital Universitario San Cecilio
Granada, 18016
958840490
Maria Isabel Blancas López-Barajas
- Not yet recruiting
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, 08907
+34932607283
Rafael Villanueva Vazquez
- Not yet recruiting
Complejo Hospitalario de Jaén
Jaén, 23007
953220306
ROCIO URBANO CUBERO
- Not yet recruiting
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016
641971167
Elena Vicente Rubio
- Not yet recruiting
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, 25198
973003754
SERAFIN MORALES MURILLO
- Not yet recruiting
Hospital Beata María Ana
Madrid, 28007
Lucia Sanz Gomez
- Not yet recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Francisco Ayala
- Not yet recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
+34913368263
Maria Fernandez Abad
- Not yet recruiting
Hospital Clinico San Carlos
Madrid, 28040
34913303000 ext 7768
Jose Angel Garcia Saenz
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
34913908626
Eva María Ciruelos Gil
- Not yet recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
Ana Luna Barrera
- Not yet recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
94951032508
Emilio Alba Conejo
- Not yet recruiting
Hospital Universitari Son Espases
Palma, 07120
34 871 206 130
Antonia Perello Martorell
- Not yet recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Cesar Rodriguez
- Not yet recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320
922677351
Josefina Cruz Jurado
- Not yet recruiting
CHUS - Hospital Clinico Universitario
Santiago de Compostela, 15706
981950511
Rafael López López
- Not yet recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Fernando Henao Carrasco
- Not yet recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Manuel Ruiz Borrego
- Not yet recruiting
Fundación Instituto Valenciano de Oncología
Valencia, 46009
ANGEL LUIS GUERRERO ZOTANO
- Not yet recruiting
Hospital Clinico de Valencia
Valencia, 46010
34961973583
Begona Bermejo de las Heras
- Not yet recruiting
Hospital Arnau de Vilanova
Valencia, 46015
Antonio Llombart Cussac
- Not yet recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
34 976 76 57 46
Raquel Andres
Japan25 sites, 25 recruiting
- Recruiting
Juntendo University Hospital
Bunkyō City, 113-8431
81120023812
Junichiro Watanabe
- Recruiting
Chiba cancer center
Chiba, 260-8717
81120023812
Rikiya Nakamura
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
81120023812
Eriko Tokunaga
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
81120023812
Makoto Kubo
- Recruiting
Fukushima Medical University
Fukushima, 960-1295
81120023812
Shigehira Saji
- Recruiting
Saitama Medical University International Medical Center
Hidaka, 350-1298
81120023812
Hiroshi Ishiguro
- Recruiting
Kansai Medical University Hospital
Hirakata, 573-1191
81120023812
Masahiro Takada
- Recruiting
Hiroshima City Hospital
Hiroshima, 730-8518
81120023812
Mitsuya Itoh
- Recruiting
Hiroshima University Hospital
Hiroshima, 734-8551
81120023812
Hideo Shigematsu
- Recruiting
Sagara Hospital
Kagoshima, 892-0833
81120023812
Tetsuhiko Taira
- Recruiting
Kanazawa Medical University Hospital
Kahoku-gun, 920-0293
81120023812
Masafumi Inokuchi
- Recruiting
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550
81120023812
Yukinori Ozaki
- Not yet recruiting
Kyoto University Hospital
Kyoto, 606-8507
81120023812
Norikazu Masuda
- Not yet recruiting
Aichi Cancer Center Hospital
Nagoya, 464-8681
81120023812
Fumikata Hara
- Recruiting
Nagoya City University Hospital
Nagoya, 467-8602
81120023812
Tatsuya Toyama
- Recruiting
Nakagami Hospital
Okinawa, 904-2142
81120023812
NORIE ABE
- Recruiting
Gunma Prefectural Cancer Center
Otashi, 373-8550
81120023812
Tomomi Fujisawa
- Recruiting
Saitama Red Cross Hospital
Saitama, 330-8553
81120023812
Kokoro Kobayashi
- Recruiting
Hokkaido University Hospital
Sapporo, 060-8648
81120023812
Masato Takahashi
- Not yet recruiting
Tohoku University Hospital
Sendai, 980-8574
81120023812
Minoru Miyashita
- Recruiting
Showa Medical University Hospital
Shinagawa City, 142-8666
81120023812
Hitomi Sakai
- Recruiting
Shizuoka General Hospital
Shizuoka, 420-8527
81120023812
Michiko Tsuneizumi
- Recruiting
The University of Osaka Hospital
Suita, 565-0871
81120023812
Tetsuhiro Yoshinami
- Not yet recruiting
Tsukuba University Hospital
Tsukuba, 305-8576
81120023812
Hiroko Bando
- Recruiting
Kanagawa cancer center
Yokohama, 2418515
81120023812
Toshinari Yamashita
Germany24 sites, 24 recruiting
- Not yet recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117
Caroline Neeb
- Not yet recruiting
Marienhospital Bottrop
Bottrop, 46236
4920411061601
Hans-Christian Kolberg
- Not yet recruiting
Universitaetsklinikum Koeln
Cologne, 50937
004922147837567
Christian Maurer
- Not yet recruiting
Städtisches Klinikum Dessau
Dessau, 06847
00493405014310
Hermann Voss
- Not yet recruiting
Onkologiezentrum Donauwörth
Donauwörth, 86609
+499062999390
Dirk Hempel
- Not yet recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
00493514586728
Pauline Wimberger
- Not yet recruiting
Kostara Gyn. Oncology Clinic Research UG
Düsseldorf, 40235
4921144773360
Athina Kostara
- Not yet recruiting
Universitaetsklinikum Erlangen
Erlangen, 91054
+4991318533572
Peter Fasching
- Not yet recruiting
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, 45136
+4920117433005
Sherko Kümmel
- Not yet recruiting
Agaplesion Markus Krankenhaus
Frankfurt, 60431
00496995332228
Marc Thill
- Not yet recruiting
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
004927030020
Beate Rautenberg
- Not yet recruiting
Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer
Friedrichshafen, 88045
Frank Mayer
- Not yet recruiting
OSP Göttingen
Göttingen, 37073
0049551488795915
Michael Metz
- Not yet recruiting
Mammazentrum HH - Krankenhaus Jerusalem
Hamburg, 20357
Christian Schem
- Not yet recruiting
Universitaetsklinikum des Saarlandes
Homburg, 66424
4968411628101
Julia Radosa
- Not yet recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
+493419723400
Bahriye Aktas
- Not yet recruiting
Klinikum Ludwigsburg
Ludwigsburg, 71640
004971419990
Claudia Haenle
- Not yet recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131
00496131170
Marcus Schmidt
- Not yet recruiting
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, 80336
004989440077581
Nadia Harbeck
- Not yet recruiting
Klinikum Ernst von Bergmann
Potsdam, 14467
+4933124135643
Dorothea Fischer
- Not yet recruiting
SRH Zentralklinikum Suhl
Suhl, 98527
00493681355016
Uwe Rhein
- Not yet recruiting
Helios HSK Wiesbaden
Wiesbaden, 65199
0049611432377
Michael Eichbaum
- Not yet recruiting
Marien Hospital Witten
Witten, 58452
004923021733290
Monika Graeser
- Not yet recruiting
HELIOS Klinikum Wuppertal
Wuppertal, 42283
0492028961411
Vesna Bjelic-Radisic
China20 sites, 20 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang, 455000
Junlan Guo
- Recruiting
Beijing Cancer hospital
Beijing, 100142
86 13811012595
Huiping Li
- Not yet recruiting
The First Hospital of Jilin University
Changchun, 130021
Lihua Kang
- Recruiting
The First People's Hospital of Changde City
Changde, 415003
Tao Wu
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
Juan Huang
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
18981838521
Jing Luo
- Recruiting
Deyang City People's Hospital
Deyang, 618099
Xinjian Jia
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, 350014
13960709993
Chuangui Song
- Recruiting
Fujian Medical University Union Hospital
Fuzhou Fujian, 350001
Jie Zhang
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, 510060
Fei Xu
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510080
kun wang
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
Li Cai
- Recruiting
Jiangmen Center Hospital
Jiangmen, 529030
18933183766
XIAOPING LI
- Recruiting
The first affiliated hospital of Ningbo university
Ningbo, 315010
0574-87085588
Yu Guo
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
13601637369
Jiong Wu
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, 515031
De Zeng
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
Yehui Shi
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
Tao Huang
- Recruiting
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030
huihua xiong
- Recruiting
Central Hospital of Guangdong Provincial Agricutural Reclamation
Zhanjiang, 524002
Yuanyuan Li
Brazil16 sites, 16 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784400
551733216637
Ana Suellen Barroso Carneiro
- Recruiting
Hospital São Domingos
Bequimão, 65060-645
+55 (98) 991187100
Ana Fonseca Alves
- Recruiting
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, 60430235
Jailson de Sousa Oliveira
- Not yet recruiting
Hospital Araújo Jorge
Goiânia, 74605070
Ruffo Freitas-Junior
- Recruiting
Hospital Brasilia
Lago Sul, 71635580
Romualdo Barroso-Sousa
- Recruiting
Hospital de Cancer de Londrina
Londrina, 86015-520
55433792608
Vitor Liutti
- Recruiting
Instituto Atena de Pesquisa Clinica - Mossoró
Mossoró, 59603-020
Stephanie Dantas
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, 59062-000
+55 84 4009 5595
Luciana Aquino Pimentel
- Not yet recruiting
Futtura Oncology - Clinical Research Hub
Porto Alegre, 90470-340
Gustavo Werutsky
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, 90610-000
555133203039
Fernanda Damian
- Not yet recruiting
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905
Jesse Silva
- Recruiting
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, 01221-020
+5511956598420
Patricia Marubayashi
- Not yet recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
551138933525
Marcela Ferrari
- Recruiting
Hospital Santa Catarina - Paulista
São Paulo, 01310-000
5511983366440
Aumilto Da Silva Junior
- Recruiting
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, 01317-000
551123598425
Roberto Hegg
- Recruiting
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002
55 11 4450-0300
Larissa Paula
France16 sites, 16 recruiting
- Not yet recruiting
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, 84918
33490276397
Julien Grenier
- Not yet recruiting
CHU Besançon
Besançon, 25000
33370632403
Laura Mansi
- Not yet recruiting
CHRU de Brest
Brest, 29609
Laura Deiana
- Not yet recruiting
Pole Santé République
Clermont-Ferrand, 63050
LIONEL MOREAU
- Not yet recruiting
Centre Georges François Leclerc
Dijon, 21079
Sylvain Ladoire
- Not yet recruiting
Clinique Victor Hugo Le Mans
Le Mans, 72000
Sophie Roche
- Not yet recruiting
Hopital Prive Jean Mermoz
Lyon, 69008
0659321781
Olfa DERBEL
- Not yet recruiting
Centre de Cancérologie du Grand Montpellier
Montpellier, 34070
467926155
Cristian Villanueva
- Not yet recruiting
Institut Curie
Paris, 75248
+33172389434
Paul COTTU
- Not yet recruiting
Hôpital Privé Des Côtes d'Armor
Plérin, 22190
Jerome Martin-Babau
- Not yet recruiting
Institut Jean Godinot
Reims, 51726
Pauline Soibinet
- Not yet recruiting
Institut Curie - site Saint-Cloud
Saint-Cloud, 92210
+33172389434
Paul COTTU
- Not yet recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
33240679977
Mario Campone
- Not yet recruiting
Oncopole Claudius Regaud
Toulouse, 31059
0531155127
Eleonora De Maio
- Not yet recruiting
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54519
Vincent Massard
- Not yet recruiting
Gustave Roussy
Villejuif, 94800
Cyril Roussel-simonin
Greece14 sites, 14 recruiting
- Not yet recruiting
Agios Savvas Regional Cancer Hospital
Athens, 115 22
Dimitrios Tryfonopoulos
- Not yet recruiting
Aretaieio Hospital
Athens, 115 28
306946462998
FLORA ZAGOURI
- Not yet recruiting
Alexandra General Hospital of Athens
Athens, 11528
30 2103381547
Maria Gavriatopoulou
- Not yet recruiting
IASO Obstetrics - Gynecology Clinic
Athens, 151 23
2106185202
STYLIANOS GIASSAS
- Not yet recruiting
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center -T
Athens, 151 23
302106185177
DIMITRA KANALOUPITIS
- Not yet recruiting
Attikon General University Hospital
Chaïdári, 12462
302105831265
Amanda Psyrri
- Not yet recruiting
University General Hospital of Heraklion
Heraklion, 715 00
2810-392750
Dimitrios Mavroudis
- Not yet recruiting
University Hospital of Ioannina
Ioannina, 455 00
STERGIOS BOUSSIOS
- Not yet recruiting
University General Hospital of Larissa
Larissa, 41110
302413502785
Athanasios Kotsakis
- Not yet recruiting
Hygeia Hospital
Marousi, 151 23
Flora Stavridi
- Not yet recruiting
University Hospital of Patras
Pátrai, 26504
302610999791
Angelos Koutras
- Not yet recruiting
European Interbalkan Medical Center
Thessaloniki, 54639
306974000528
Ippokratis Korantzis
- Not yet recruiting
European Interbalkan Medical Center
Thessaloniki, 570 01
306947330432
Konstantinos Papazisis
- Not yet recruiting
European Interbalkan Medical Center
Thessaloniki, 570 01
Sofia Baka
Argentina13 sites, 13 recruiting
- Recruiting
CIPREC
Buenos Aires, 1061
5491150523121
Ezequiel Slutsky
- Recruiting
Centro de Investigaciones Medicas y Desarrollo LC
Buenos Aires, 1113
5491133147765
Monica Casalnuovo
- Recruiting
Investigaciones Clinicas Moleculares (ICM)
Buenos Aires, 1425
Nicolas Torressi
- Recruiting
Centro Oncologico Korben
Buenos Aires, 1426
5491163819972
Ernesto Korbenfeld
- Recruiting
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO
1130051657
Margarita Alfie
- Not yet recruiting
Focus CECIC
Buenos Aires, C1425BKU
Danisa Fariña
- Not yet recruiting
Fundación Respirar
Buenos Aires, C1426ABP
5411 70781548
Christian Fuentes
- Not yet recruiting
Instituto de Investigaciones Clínicas Córdoba
Córdoba, X5000AAW
93516778868
Santiago Bella
- Recruiting
Fundación Innovaciencia
Rosario, 2000
Mariana Queralt
- Recruiting
Hospital Provincial del Centenario
Rosario, S2002KDS
341-5717551
Andrea Pastor
- Not yet recruiting
COE (Centro Oncológico de Excelencia)
San Juan, 5400
542644211086
Juan Puig
- Not yet recruiting
Instituto San Marcos
San Juan, 5400
549-264-4826407
Alejandro Roses Videla
- Recruiting
Go Centro Medico San Nicolás
San Nicolás, 2900
03364456047
Vanina Binner
Italy12 sites, 12 recruiting
- Not yet recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
Alberto Zambelli
- Not yet recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138
Claudio Zamagni
- Not yet recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Icro Meattini
- Not yet recruiting
Ospedale San Martino
Genova, 16132
390105558904
Lucia Del Mastro
- Not yet recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
0039 347 488 6271
Michela Palleschi
- Not yet recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
00390257489215
Giuseppe Curigliano
- Not yet recruiting
Humanitas Istituto Clinico Catanese
Misterbianco, 95045
PAOLO VIGNERI
- Not yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
390392339037
Marina Cazzaniga
- Not yet recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
+390817463660
Grazia Arpino
- Not yet recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
3908117770442
Michelino De Laurentiis
- Not yet recruiting
Istituto Oncologico Veneto IRCCS
Padova, 35128
0039 0498 215931
Valentina Guarneri
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
393393018718
IDA PARIS
Turkey (Türkiye)11 sites, 11 recruiting
- Not yet recruiting
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 01250
905353067506
Ozgur Ozyilkan
- Not yet recruiting
Adana City Hospital
Adana, 01370
90538 609 92 02
Timucin Cil
- Not yet recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, 06200
Ozturk Ates
- Not yet recruiting
Ankara University Health Practice and Research Hospitals
Ankara, 06620
00903125957321
Yuksel Urun
- Not yet recruiting
Aydın Adnan Menderes Universitesi Hastanesi
Aydin, 09100
00905053170639
Esin Oktay
- Not yet recruiting
Trakya University
Edirne, 22030
905326845953
Sernaz Topaloglu
- Not yet recruiting
Koç Üniversitesi Hastanesi
Istanbul, 34010
+905323860161
Fatih Selcukbiricik
- Not yet recruiting
Yeditepe Üniversitesi Koşuyolu Hastanesi
Istanbul, 34718
Serkan Celik
- Not yet recruiting
Acibadem Atasehir Hospital
Istanbul, 34758
+90 532 590 70 57
Ozge Gumusay
- Not yet recruiting
Ege Universitesi Hastanesi
Izmir, 35100
905324510608
Burcu Cakar
- Not yet recruiting
Mersin Sehir Eğitim ve Araştırma Hastanesi
Mersin, 33240
Ali Inal
Australia10 sites, 10 recruiting
- Recruiting
Ballarat Health Services
Ballarat Central, 3350
James Ridgwell
- Recruiting
The Prince Charles Hospital
Brisbane, 4032
61 7 3176 2111
Kyung Ha (Kathy) You
- Recruiting
St Vincent's Hospital
Darlinghurst, 2010
0293555652
Elgene Lim
- Not yet recruiting
Royal Hobart Hospital
Hobart, 7000
0361666655
Melanie Wuttke
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
Julia Dixon-Douglas
- Recruiting
Lake Macquarie Private Hospital
Newcastle, 2290
0424579224
Nicholas Zdenkowski
- Recruiting
Macquarie University
North Ryde, 2109
Dhanusha Sabanathan
- Recruiting
Goulburn Valley Health
Shepparton, 3630
+61 3 5832 2322
Arvind Sahu
- Recruiting
St. John of God Subiaco Hospital
Subiaco, 6008
Daphne Tsoi
- Recruiting
The Townsville Hospital
Townsville, 4814
61744331111
Joanne Tan
South Korea10 sites, 10 recruiting
- Not yet recruiting
Soon Chun Hyang University Cheonan Hospital
Cheonan-si, 31151
82-10-2529-3895
Han Jo Kim
- Not yet recruiting
Kyungpook National University Chilgok Hospital
Deagu, 41404
+82 53 200 3011
Yee Soo Chae
- Not yet recruiting
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, 06273
020193305
Jee Hung Kim
- Not yet recruiting
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415
Sung Ae Koh
- Not yet recruiting
Inha University Hospital
Incheon, 22332
Moon Hee Lee
- Not yet recruiting
Korea University Anam Hospital
Seoul, 02841
1047617651
Kyong Hwa Park
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
82220720795
Seock-Ah Im
- Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
82222288135
Joo Hyuk Sohn
- Not yet recruiting
Asan Medical Center
Seoul, 05505
82230103217
Sung-Bae Kim
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
Hee Kyung Ahn
United Kingdom8 sites, 8 recruiting
- Not yet recruiting
Western General Hospital
Edinburgh, EH4 2XU
01316518709
Olga Oikonomidou
- Recruiting
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA
Heeranand Keswani
- Not yet recruiting
St Bartholomew's Hospital
London, EC1A 7BE
02078828494
Peter Schmid
- Recruiting
Royal Marsden Hospital (Sutton)
London, SM2 5PT
Emma Kipps
- Recruiting
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ
Emma Kipps
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
sacha howell
- Recruiting
Derriford Hospital
Plymouth, Pl6 8DH
Udaiveer Panwar
- Not yet recruiting
Worcestershire Royal Hospital
Worcester, WR5 1DD
Subhadeep Bose
Belgium7 sites, 7 recruiting
- Not yet recruiting
Institut Jules Bordet
Anderlecht, 1070
3225413188
Philippe Aftimos
- Not yet recruiting
Jessa Ziekenhuis
Hasselt, 3500
+3211337979
Jeroen Mebis
- Not yet recruiting
AZ Groeninge Campus Kennedylaan
Kortrijk, 8500
3256633900
Laure Nuytemans
- Not yet recruiting
UZ Leuven
Leuven, 3000
003216345129
Patrick Neven
- Not yet recruiting
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000
003281720524
Donatienne Taylor
- Not yet recruiting
Clinique Saint Pierre
Ottignies, 1340
003210437648
Renaud Poncin
- Not yet recruiting
AZ Nikolaas
Sint-Niklaas, B-9100
3237602975
Ines Deleu
Taiwan7 sites, 7 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
886-42359-2525-5031
Chih-Chiang Hung
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
886-6-2353535 x4620
Wei-Pang Chung
- Recruiting
Chi Mei Medical Center
Tainan, 71004
Yu-Hsuan Kuo
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Dwan-Ying Chang
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
886228712121
Ling-Ming Tseng
- Not yet recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112
02289700111686
Chi-Feng Chung
- Not yet recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Yung-Chang Lin
Ireland6 sites, 6 recruiting
- Not yet recruiting
Bon Secours Cork Hospital
Cork, T12 DV56
DEIRDRE O'MAHONY
- Not yet recruiting
St. Vincent's University Hospital
Dublin, D04 T6F4
012214000
Janice Walshe
- Not yet recruiting
Mater Misericordiae University Hospital
Dublin, D07 R2WY
Shahid Iqbal
- Not yet recruiting
St. James's Hospital
Dublin, D08 E9P6
014103000
Ciara O Hanlon Brown
- Not yet recruiting
Beaumont Hospital, Dublin
Dublin, D9
3538092010
Patrick Morris
- Not yet recruiting
Galway University Hospital
Galway, H91 YR71
Maccon Keane
Canada4 sites, 4 recruiting
- Not yet recruiting
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, L8V5C2
Haider Samawi
- Not yet recruiting
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
Québec, G1S 4L8
Julie Lemieux
- Not yet recruiting
Princess Margaret Cancer Centre
Toronto, M5G 2M9
416 946 4534
Philippe Bedard
- Not yet recruiting
BC Cancer Vancouver
Vancouver, V5Z 4E6
Stephen Chia
Singapore3 sites, 3 recruiting
- Not yet recruiting
National University Hospital
Singapore, 119074
Andrea Wong
- Not yet recruiting
National Cancer Centre Singapore
Singapore, 168583
6564368000
Yoon Sim Yap
- Not yet recruiting
Tan Tock Seng Hospital
Singapore, 308433
Valerie Heong
About this study
Official title: A Phase 2, Randomized, Open-Label Dose Optimization and 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.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Being tested
- LY4064809, Placebo, Ribociclib, Palbociclib, Abemaciclib
- Keywords
- STX-478, PI3K
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4064809Drug
Also called STX-478, Tersolisib
Administered orally
PlaceboDrug
Administered orally
RibociclibDrug
Administered orally
PalbociclibDrug
Administered orally
AbemaciclibDrug
Also called LY2835219
Administered orally
AnastrozoleDrug
Administered orally
LetrozoleDrug
Administered orally
ExemestaneDrug
Administered orally
FulvestrantDrug
Administered intramuscular
| Study group | Role | What they receive |
|---|---|---|
| LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 1) | Experimental | 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 Receives: Drug: LY4064809; Drug: Ribociclib; Drug: Palbociclib; Drug: Abemaciclib; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Fulvestrant |
| LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2) | Experimental | LY4064809 given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly Receives: Drug: LY4064809; Drug: Ribociclib; Drug: Palbociclib; Drug: Abemaciclib; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Fulvestrant |
| Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2) | Placebo comparator | Placebo given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly Receives: Drug: Placebo; Drug: Ribociclib; Drug: Palbociclib; Drug: Abemaciclib; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Measured: Baseline through disease progression or death (Estimated up to 5 years)
(Part 2): Progression-Free Survival
Investigator-assessed
Measured: Baseline to objective progression or death due to any cause (Estimated up to 5 years)
Secondary outcomes (14)
(Part 1): Disease Control Rate (DCR)
per RECIST v1.1
Measured: Baseline through measured progressive disease (Estimated up to 5 years)
(Part 1): Time to Response (TTR)
per RECIST v1.1
Measured: 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)
per RECIST v1.1
Measured: 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
per RECIST v1.1
Measured: Baseline to objective progression or death due to any cause (Estimated up to 5 years)
(Parts 1 and 2): Overall Survival (OS)
Measured: Baseline to deaths from any cause (Estimated up to 7 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
per RECIST v1.1
Measured: Baseline to disease progression or death from any cause (Estimated up to 5 years)
(Parts 1 and 2): PK: Average Plasma Concentrations of tersolisib
Measured: Baseline to last PK sample collection up to 5 months
(Part 2): Progression-Free Survival after Subsequent Line of Treatment (PFS2)
Investigator-assessed
Measured: 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)
By BICR
Measured: Baseline to objective progression or death from any cause (Estimated up to 5 years)
(Part 2): Objective Response Rate (ORR)
By investigator and blinded independent central review (BICR)
Measured: Baseline to disease progression or death from any cause (Estimated up to 5 years)
(Part 2): Time to Chemotherapy (TTC)
Measured: Baseline until the start of chemotherapy (Estimated up to 7 years)
(Part 2): Chemotherapy-Free Survival
Measured: 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
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.
Measured: 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
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.
Measured: Baseline until disease progression or death (Estimated up to 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start22 Dec 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174336
- Sponsor's protocol ID
- 27726
- Other IDs
- 2025-522791-92-00, J6M-MC-JSGD, 2025
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.