ClinicalTrials.gov record
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
ClinicalTrials.gov ID: NCT07174336
Public ClinicalTrials.gov record NCT07174336. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07174336
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 800 participants
Conditions and interventions
Conditions
Interventions
- LY4064809 Drug
- Placebo Drug
- Ribociclib Drug
- Palbociclib Drug
- Abemaciclib Drug
- Anastrozole Drug
- Letrozole Drug
- Exemestane Drug
- Fulvestrant Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2025
- Primary completion
- Apr 30, 2029
- Completion
- Apr 30, 2033
- Last update posted
- Aug 20, 2026
2025 – 2033
United States locations
- U.S. sites
- 126
- U.S. states
- 38
- U.S. cities
- 111
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Oncology and Hematology | Anchorage | Alaska | 99508 | Not yet recruiting |
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | Recruiting |
| Mayo Clinic in Arizona - Phoenix | Phoenix | Arizona | 85054 | Not yet recruiting |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | 85719 | Recruiting |
| Genesis Cancer and Blood Institute | Hot Springs | Arkansas | 71913 | Not yet recruiting |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | Recruiting |
| Community Cancer Institute | Clovis | California | 93611 | Not yet recruiting |
| City of Hope | Duarte | California | 91010 | Recruiting |
| Epic Care - Emeryville | Emeryville | California | 94608 | Not yet recruiting |
| Marin Cancer Care | Greenbrae | California | 94904 | Recruiting |
| Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine | Irvine | California | 92612 | Not yet recruiting |
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | 92618 | Recruiting |
| Moores Cancer Center | La Jolla | California | 92093 | Not yet recruiting |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Not yet recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | Not yet recruiting |
| Kaiser Permanente Oakland | Oakland | California | 94611 | Not yet recruiting |
| Profound Research LLC | Oceanside | California | 92056 | Recruiting |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center | Orange | California | 92868 | Not yet recruiting |
| Desert Regional Medical Center | Palm Springs | California | 92262 | Not yet recruiting |
| Stanford Cancer Center | Palo Alto | California | 94304 | Not yet recruiting |
| Kaiser Permanente | Roseville | California | 95661 | Not yet recruiting |
| Kaiser Permanente | San Francisco | California | 94115 | Not yet recruiting |
| UCSF Medical Center at Mission Bay | San Francisco | California | 94158 | Suspended |
| Kaiser Permanente | Santa Clara | California | 95051 | Not yet recruiting |
| UCLA Hematology/Oncology - Parkside | Santa Monica | California | 90404 | Not yet recruiting |
| Providence Medical Foundation | Santa Rosa | California | 95403 | Recruiting |
| Kaiser Permanente | Vallejo | California | 94589 | Not yet recruiting |
| Kaiser Permanente Walnut Creek | Walnut Creek | California | 94596 | Not yet recruiting |
| UCHealth Harmony | Fort Collins | Colorado | 80528 | Not yet recruiting |
| Cancer Centers of Colorado St. Mary's Regional Hospital | Grand Junction | Colorado | 81501 | Not yet recruiting |
| Banner MD Anderson Cancer Center at North Colorado Medical Center | Greeley | Colorado | 80631 | Not yet recruiting |
| Banner MD Anderson Cancer Center at McKee Medical Center | Loveland | Colorado | 80538 | Not yet recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Recruiting |
| AdventHealth Altamonte Springs | Altamonte Springs | Florida | 32701 | Not yet recruiting |
| Clermont Oncology Center | Clermont | Florida | 34711 | Recruiting |
| Florida Oncology & Hematology | Fort Myers | Florida | 33912 | Not yet recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | Not yet recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami | Florida | 33136 | Not yet recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | Recruiting |
| Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center | Tampa | Florida | 33612 | Not yet recruiting |
| Central Georgia Cancer Care | Macon | Georgia | 31210 | Not yet recruiting |
| City of Hope National Medical Center, Atlanta Cancer Center | Newnan | Georgia | 30265 | Recruiting |
| Low Country Cancer Care | Savannah | Georgia | 31404 | Not yet recruiting |
| Summit Cancer Care, PC | Savannah | Georgia | 31405 | Recruiting |
| Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii | 96819 | Not yet recruiting |
| City of Hope, Chicago | Chicago | Illinois | 60611 | Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | Not yet recruiting |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | Not yet recruiting |
| Endeavor Health | Evanston | Illinois | 60201 | Not yet recruiting |
| Accellacare of Duly | Lisle | Illinois | 60532 | Not yet recruiting |
| Simmons Cancer Institute at SIU | Springfield | Illinois | 62702 | Not yet recruiting |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | Recruiting |
| Deaconess GI Specialty Center | Newburgh | Indiana | 47630 | Not yet recruiting |
| University of Iowa | Iowa City | Iowa | 52242 | Not yet recruiting |
| Saint Elizabeth Medical Center Edgewood | Edgewood | Kentucky | 41017 | Not yet recruiting |
| Our Lady of the Lake RMC | Baton Rouge | Louisiana | 70808 | Not yet recruiting |
| New England Cancer Specialists | Westbrook | Maine | 04092 | Not yet recruiting |
| American Oncology Partners, PA | Bethesda | Maryland | 20817 | Not yet recruiting |
| James M Stockman Cancer Institute | Frederick | Maryland | 21702 | Not yet recruiting |
| Mass General Cancer Center | Boston | Massachusetts | 02114 | Not yet recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Not yet recruiting |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | Not yet recruiting |
| Profound Research LLC | Sterling Heights | Michigan | 48314 | Not yet recruiting |
| Allina Health Cancer Institute - Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | Not yet recruiting |
| Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota | 55905 | Not yet recruiting |
| Metro-Minnesota Community Clinical Oncology | Saint Louis Park | Minnesota | 55426 | Not yet recruiting |
| North Mississippi Hematology and Oncology Associates | Tupelo | Mississippi | 38801 | Not yet recruiting |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | Not yet recruiting |
| Oncology Hematology Associates | Springfield | Missouri | 65807 | Not yet recruiting |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | Not yet recruiting |
| Jefferson Health - Cherry Hill | Cherry Hill | New Jersey | 08002 | Recruiting |
| Sidney Kimmel Cancer Center - Washington Township | Sewell | New Jersey | 08080 | Recruiting |
| Atlantic Health System Overlook Medical Center | Summit | New Jersey | 07901 | Recruiting |
| NYOH Albany Cancer Center | Albany | New York | 12206 | Not yet recruiting |
| New York University (NYU) Brooklyn | Brooklyn | New York | 11220 | Not yet recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Not yet recruiting |
| NYC Health + Hospitals / Bellevue | New York | New York | 11106 | Not yet recruiting |
| Messino Cancer Centers | Asheville | North Carolina | 28806 | Recruiting |
| WakeMed Cancer Care - Waverly Hematology & Medical Oncology | Cary | North Carolina | 27518 | Not yet recruiting |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27599 | Not yet recruiting |
| Carolina Cancer Research Center | Wilson | North Carolina | 27893 | Not yet recruiting |
| Sanford Fargo Medical Center | Fargo | North Dakota | 58102 | Not yet recruiting |
| Cleveland Clinic Akron General | Akron | Ohio | 44302 | Not yet recruiting |
| Gabrail Cancer Center | Canton | Ohio | 44718 | Not yet recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Not yet recruiting |
| Fairview Hospital | Cleveland | Ohio | 44111 | Not yet recruiting |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T | Columbus | Ohio | 43210 | Not yet recruiting |
| Cleveland Clinic - Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | Not yet recruiting |
| Good Samaritan Regional Medical Center | Corvallis | Oregon | 97330 | Recruiting |
| Oncology Associates of Oregon | Eugene | Oregon | 97401 | Recruiting |
| Oregon Health and Science University | Portland | Oregon | 97239 | Not yet recruiting |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | Not yet recruiting |
| Lancaster General Hospital - Ann B Barshinger Cancer Institute | Lancaster | Pennsylvania | 17601 | Not yet recruiting |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| Thomas Jefferson University - Clinical Research Institute | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Jefferson Hospital Northeast | Philadelphia | Pennsylvania | 19114 | Recruiting |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Not yet recruiting |
| Sanford Cancer Center | Sioux Falls | South Dakota | 57104 | Not yet recruiting |
| Sarah Cannon Research Institute SCRI | Nashville | Tennessee | 37203 | Recruiting |
| Nashville General Hospital | Nashville | Tennessee | 37208 | Not yet recruiting |
| Hendrick Medical Center | Abilene | Texas | 79601 | Not yet recruiting |
| World Research Link | Baytown | Texas | 77521 | Recruiting |
| Parkland Health and Hospital System | Dallas | Texas | 75235 | Not yet recruiting |
| USO - Texas Oncology | Dallas | Texas | 75246 | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Texas Oncology - West Texas | El Paso | Texas | 79902 | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | Not yet recruiting |
| Houston Methodist Hospital | Houston | Texas | 77030 | Not yet recruiting |
| Oncology Consultants P.A. | Houston | Texas | 77030 | Recruiting |
| Nova Oncology | McAllen | Texas | 78504 | Recruiting |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78240 | Recruiting |
| US Oncology Research Network | The Woodlands | Texas | 77380 | Recruiting |
| Tranquility Research | Webster | Texas | 77598 | Not yet recruiting |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | Not yet recruiting |
| The University of Vermont Medical Center Inc. | Burlington | Vermont | 05401 | Not yet recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Not yet recruiting |
| Swedish Cancer Institute - Edmonds | Edmonds | Washington | 98026 | Not yet recruiting |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | Not yet recruiting |
| UW Medicine Valley Medical Center | Renton | Washington | 98055 | Recruiting |
| Swedish Medical Center | Seattle | Washington | 98104 | Not yet recruiting |
| Deaconess Hospital | Spokane | Washington | 99204 | Not yet recruiting |
| Cancer Care Northwest - Vercler | Spokane Valley | Washington | 99216 | Not yet recruiting |
| MultiCare Health System | Tacoma | Washington | 98405 | Not yet recruiting |
| North Star Lodge | Yakima | Washington | 98902 | Not yet recruiting |
| ThedaCare Physicians - Appleton North | Appleton | Wisconsin | 54911 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 232 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07174336, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07174336 live on ClinicalTrials.gov.