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

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Eli Lilly and Company
Study ID
NCT07174336
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY4064809 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally
  • Ribociclib — DRUG
    Administered orally
  • Palbociclib — DRUG
    Administered orally
  • Abemaciclib — DRUG
    Administered orally
  • Anastrozole — DRUG
    Administered orally
  • Letrozole — DRUG
    Administered orally
  • Exemestane — DRUG
    Administered orally
  • Fulvestrant — DRUG
    Administered intramuscular

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
May 31, 2033

Study Design

Enrollment
920 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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
  • 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

Primary Outcome Measure

(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) ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (117)

FacilityCityStateZIPSite coordinators
Alaska Oncology and HematologyAnchorageAlaska99508
907-257-9851
Steven Liu (PRINCIPAL_INVESTIGATOR)
Ironwood Cancer & Research CentersChandlerArizona85224
Jasleen Khanuja (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in Arizona - PhoenixPhoenixArizona85054
480-301-8000
Shakeela Bahadur (PRINCIPAL_INVESTIGATOR)
The University of Arizona Cancer Center - North CampusTucsonArizona85719
Sima Ehsani (PRINCIPAL_INVESTIGATOR)
Genesis Cancer and Blood InstituteHot SpringsArkansas71913
501-624-7700
Stephen Divers (PRINCIPAL_INVESTIGATOR)
Highlands Oncology GroupSpringdaleArkansas72762
479-872-8130
Joseph Beck (PRINCIPAL_INVESTIGATOR)
Community Cancer InstituteClovisCalifornia93611
Li Ge (PRINCIPAL_INVESTIGATOR)
City of HopeDuarteCalifornia91010
Hope Rugo (PRINCIPAL_INVESTIGATOR)
Marin Cancer CareGreenbraeCalifornia94904
Cyrus Mazidi (PRINCIPAL_INVESTIGATOR)
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - IrvineIrvineCalifornia92612
714-456-8614
Ritesh Parajuli (PRINCIPAL_INVESTIGATOR)
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618
Hope Rugo (PRINCIPAL_INVESTIGATOR)
Moores Cancer CenterLa JollaCalifornia92093
Xiaojie Zhang (PRINCIPAL_INVESTIGATOR)
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
323-397-5954
Daphne Stewart (PRINCIPAL_INVESTIGATOR)
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Chaitali Nangia (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente OaklandOaklandCalifornia94611
707-651-5213
Jennifer Suga (PRINCIPAL_INVESTIGATOR)
Profound Research LLCOceansideCalifornia92056
Catherine Quinn (PRINCIPAL_INVESTIGATOR)
University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrangeCalifornia92868
714-456-8614
Ritesh Parajuli (PRINCIPAL_INVESTIGATOR)
Desert Regional Medical CenterPalm SpringsCalifornia92262
760-416-4749
Kim Phan (PRINCIPAL_INVESTIGATOR)
Stanford Cancer CenterPalo AltoCalifornia94304
Fauzia Riaz (PRINCIPAL_INVESTIGATOR)
Kaiser PermanenteRosevilleCalifornia95661
Jennifer Suga (PRINCIPAL_INVESTIGATOR)
Kaiser PermanenteSan FranciscoCalifornia94115
707-651-5213
Jennifer Suga (PRINCIPAL_INVESTIGATOR)
UCSF Medical Center at Mission BaySan FranciscoCalifornia94158-
Kaiser PermanenteSanta ClaraCalifornia95051
Jennifer Suga (PRINCIPAL_INVESTIGATOR)
UCLA Hematology/Oncology - ParksideSanta MonicaCalifornia90404
310-998-4747
Nicholas McAndrew (PRINCIPAL_INVESTIGATOR)
Providence Medical FoundationSanta RosaCalifornia95403
Ian Anderson (PRINCIPAL_INVESTIGATOR)
Kaiser PermanenteVallejoCalifornia94589
Jennifer Suga (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente Walnut CreekWalnut CreekCalifornia94596
707-651-2797
Jennifer Suga (PRINCIPAL_INVESTIGATOR)
Cancer Centers of Colorado St. Mary's Regional HospitalGrand JunctionColorado81501
970-298-7500
Alicia Swink (PRINCIPAL_INVESTIGATOR)
Banner MD Anderson Cancer Center at North Colorado Medical CenterGreeleyColorado80631
970-810-3894
Esther Mondo (PRINCIPAL_INVESTIGATOR)
Banner MD Anderson Cancer Center at McKee Medical CenterLovelandColorado80538
970-810-3894
Esther Mondo (PRINCIPAL_INVESTIGATOR)
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Ami Chitalia (PRINCIPAL_INVESTIGATOR)
AdventHealth Altamonte SpringsAltamonte SpringsFlorida32701
Wassim Mchayleh (PRINCIPAL_INVESTIGATOR)
Clermont Oncology CenterClermontFlorida34711
352-242-1366
Gopal Kunta (PRINCIPAL_INVESTIGATOR)
Florida Oncology & HematologyFort MyersFlorida33912
239-264-7026
Venkata Parsa (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224
904-953-2000
Rishitha Bollam (PRINCIPAL_INVESTIGATOR)
University of Miami Hospital and Clinics, Sylvester Cancer CenterMiamiFlorida33136
Frances Valdes (PRINCIPAL_INVESTIGATOR)
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763
386-774-1223
Santosh Nair (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient CenterTampaFlorida33612
Aixa Soyano (PRINCIPAL_INVESTIGATOR)
Central Georgia Cancer CareMaconGeorgia31210
478-336-5708
Bradley Sumrall (PRINCIPAL_INVESTIGATOR)
City of Hope National Medical Center, Atlanta Cancer CenterNewnanGeorgia30265
Sarah Friend (PRINCIPAL_INVESTIGATOR)
Summit Cancer Care, PCSavannahGeorgia31405
912-651-5771
Alison Spellman (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente Moanalua Medical CenterHonoluluHawaii96819
808-432-8000
Jennifer Carney (PRINCIPAL_INVESTIGATOR)
City of Hope, ChicagoChicagoIllinois60611
Ajaz M. Khan (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
William Gradishar (PRINCIPAL_INVESTIGATOR)
University of Illinois at ChicagoChicagoIllinois60612
312-996-1581
Vijayakrishna Gadi (PRINCIPAL_INVESTIGATOR)
Accellacare of DulyLisleIllinois60532
Daniel Frank (PRINCIPAL_INVESTIGATOR)
Simmons Cancer Institute at SIUSpringfieldIllinois62702
217-545-8000
Krishna Rao (PRINCIPAL_INVESTIGATOR)
Indiana University Health University HospitalIndianapolisIndiana46202
Tarah Ballinger (PRINCIPAL_INVESTIGATOR)
Deaconess Chancellor Center for OncologyNewburghIndiana47630
Karim Anwar (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
319-353-6665
Mark Burkard (PRINCIPAL_INVESTIGATOR)
Saint Elizabeth Medical Center EdgewoodEdgewoodKentucky41017
Matthew Kurian (PRINCIPAL_INVESTIGATOR)
Our Lady of the Lake RMCBaton RougeLouisiana70808
Marshall Stagg (PRINCIPAL_INVESTIGATOR)
New England Cancer SpecialistsWestbrookMaine04092
Eleni Nackos (PRINCIPAL_INVESTIGATOR)
American Oncology Partners, PABethesdaMaryland20817
301-571-2016
Victor Priego (PRINCIPAL_INVESTIGATOR)
James M Stockman Cancer InstituteFrederickMaryland21702
Natalia Marina (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
617-632-3800
Antonio Giordano (PRINCIPAL_INVESTIGATOR)
Mass General Cancer CenterBostonMassachusetts02114
Dejan Juric (PRINCIPAL_INVESTIGATOR)
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical CenterMilfordMassachusetts01757
508-488-3700
Natalie Sinclair (PRINCIPAL_INVESTIGATOR)
Dana-Farber/Brigham and Women's Cancer Center - South Shore HospitalSouth WeymouthMassachusetts02190
James Stoeckle (PRINCIPAL_INVESTIGATOR)
University of Massachusetts Medical SchoolWorcesterMassachusetts01655
508-856-3216
Madhavi Toke (PRINCIPAL_INVESTIGATOR)
Profound Research LLCSterling HeightsMichigan48314
Laura Kohler (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in Rochester, MinnesotaRochesterMinnesota55905
507-284-2511
Matthew Goetz (PRINCIPAL_INVESTIGATOR)
North Mississippi Hematology and Oncology AssociatesTupeloMississippi38801
Rana Usman (PRINCIPAL_INVESTIGATOR)
Saint Luke's Cancer InstituteKansas CityMissouri64111
816-932-2677
Timothy Pluard (PRINCIPAL_INVESTIGATOR)
Oncology Hematology AssociatesSpringfieldMissouri65807
417-882-4880
Viran Holden (PRINCIPAL_INVESTIGATOR)
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Muhammad Afzal (PRINCIPAL_INVESTIGATOR)
Jefferson Health - Cherry HillCherry HillNew Jersey08002
Steven Manobianco (PRINCIPAL_INVESTIGATOR)
Sidney Kimmel Cancer Center - Washington TownshipSewellNew Jersey08080
Steven Manobianco (PRINCIPAL_INVESTIGATOR)
Atlantic Health System Overlook Medical CenterSummitNew Jersey07901
Bonni Guerin (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
646-888-5157
Komal Jhaveri (PRINCIPAL_INVESTIGATOR)
Messino Cancer CentersAshevilleNorth Carolina28806
Rachel Raab (PRINCIPAL_INVESTIGATOR)
WakeMed Cancer Care - Waverly Hematology & Medical OncologyCaryNorth Carolina27518
919-350-2873
Pallavi Kopparthy (PRINCIPAL_INVESTIGATOR)
University of North Carolina Medical CenterChapel HillNorth Carolina27599
919-260-4616
Elizabeth Dees (PRINCIPAL_INVESTIGATOR)
Carolina Cancer Research CenterWilsonNorth Carolina27893
Keith Lerro (PRINCIPAL_INVESTIGATOR)
Sanford Fargo Medical CenterFargoNorth Dakota58102
Anu Gaba (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Akron GeneralAkronOhio44302
330-888-4000
Daniel Silbiger (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer CenterCantonOhio44718
330-492-3345
Nashat Gabrail (PRINCIPAL_INVESTIGATOR)
Fairview HospitalClevelandOhio44111
330-888-4000
Daniel Silbiger (PRINCIPAL_INVESTIGATOR)
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -TColumbusOhio43210
614-366-1525
Robert Wesolowski (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic - Hillcrest HospitalMayfield HeightsOhio44124
330-888-4000
Daniel Silbiger (PRINCIPAL_INVESTIGATOR)
Good Samaritan Regional Medical CenterCorvallisOregon97330
John Strother (PRINCIPAL_INVESTIGATOR)
Oncology Associates of OregonEugeneOregon97401
Miho Dougherty (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
971-262-9600
Annie Hung (PRINCIPAL_INVESTIGATOR)
St. Luke's University Health NetworkBethlehemPennsylvania18015
Maria Hafez (PRINCIPAL_INVESTIGATOR)
Lancaster General Hospital - Ann B Barshinger Cancer InstituteLancasterPennsylvania17601
Amy Clark (PRINCIPAL_INVESTIGATOR)
Jefferson Hospital NortheastPhiladelphiaPennsylvania19114
Steven Manobianco (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University - Clinical Research InstitutePhiladelphiaPennsylvania19107
Steven Manobianco (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104
Amy Clark (PRINCIPAL_INVESTIGATOR)
Asplundh Cancer PavilionWillow GrovePennsylvania19090
Steven Manobianco (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
843-792-9300
Abirami Sivapiragasam (PRINCIPAL_INVESTIGATOR)
Nashville General HospitalNashvilleTennessee37208
615-341-4383
Robin Jacob (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute SCRINashvilleTennessee37203
SMO Sarah Cannon Research Inst. (PRINCIPAL_INVESTIGATOR)
Hendrick Medical CenterAbileneTexas79601
325-670-7724
Jose Velasco Di Domenico (PRINCIPAL_INVESTIGATOR)
World Research LinkBaytownTexas77521
833-832-8328
Amir Rasheed (PRINCIPAL_INVESTIGATOR)
Parkland Health and Hospital SystemDallasTexas75235
214-648-4180
Nisha Unni (PRINCIPAL_INVESTIGATOR)
USO - Texas OncologyDallasTexas75246
Joyce O'Shaughnessy (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
214-648-4180
Nisha Unni (PRINCIPAL_INVESTIGATOR)
Texas Oncology - West TexasEl PasoTexas79902
Ines Sanchez (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Hanh Mai (PRINCIPAL_INVESTIGATOR)
Oncology Consultants P.A.HoustonTexas77030
713-600-0900
Ricardo Alvarez (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009
832-728-7423
Senthil Damodaran (PRINCIPAL_INVESTIGATOR)
Nova OncologyMcAllenTexas78504
281-944-3610
Raghad Muhsin Abdul Karim, MD (PRINCIPAL_INVESTIGATOR)
Texas Oncology - San Antonio Medical CenterSan AntonioTexas78240
Emmalind Aponte (PRINCIPAL_INVESTIGATOR)
US Oncology Research NetworkThe WoodlandsTexas77380
SMO Sarah Cannon Research Inst. (PRINCIPAL_INVESTIGATOR)
Tranquility ResearchWebsterTexas77598
John Knecht (PRINCIPAL_INVESTIGATOR)
Utah Cancer SpecialistsSalt Lake CityUtah84106
Stephan Kendall (PRINCIPAL_INVESTIGATOR)
The University of Vermont Medical Center Inc.BurlingtonVermont05405
Peter Kaufman (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Shruti Tiwari (PRINCIPAL_INVESTIGATOR)
Swedish Cancer Institute - EdmondsEdmondsWashington98026
Michaela Tsai (PRINCIPAL_INVESTIGATOR)
Providence Regional Cancer PartnershipEverettWashington98201
Xiaowen Wang (PRINCIPAL_INVESTIGATOR)
UW Medicine Valley Medical CenterRentonWashington98055
425-690-3503
Navanshu Arora (PRINCIPAL_INVESTIGATOR)
Swedish Medical CenterSeattleWashington98104
Michaela Tsai (PRINCIPAL_INVESTIGATOR)
Deaconess HospitalSpokaneWashington99204
Blair Irwin (PRINCIPAL_INVESTIGATOR)
Cancer Care Northwest - VerclerSpokane ValleyWashington99216
Saritha Thumma (PRINCIPAL_INVESTIGATOR)
MultiCare Health SystemTacomaWashington98405
Blair Irwin (PRINCIPAL_INVESTIGATOR)
North Star LodgeYakimaWashington98902
Blair Irwin (PRINCIPAL_INVESTIGATOR)
ThedaCare Physicians - Appleton NorthAppletonWisconsin54911
920-364-3600
Shannon Schmidt (PRINCIPAL_INVESTIGATOR)

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