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.
ClinicalTrials.gov public records Last synced May 5, 2026, 9:29 PM EDT
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 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
Study identification
- NCT ID
- NCT07174336
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Eli Lilly and Company
- Industry
- Enrollment
- 920 participants
Conditions and interventions
Conditions
Interventions
- Abemaciclib Drug
- Anastrozole Drug
- Exemestane Drug
- Fulvestrant Drug
- LY4064809 Drug
- Letrozole Drug
- Palbociclib Drug
- Placebo Drug
- Ribociclib 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
- Apr 28, 2026
2025 – 2033
United States locations
- U.S. sites
- 110
- U.S. states
- 35
- U.S. cities
- 98
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Oncology and Hematology | Anchorage | Alaska | 99508 | Not yet recruiting |
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | Not yet recruiting |
| Mayo Clinic in Arizona - Phoenix | Phoenix | Arizona | 85054 | Not yet recruiting |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | 85719 | Not yet recruiting |
| Genesis Cancer and Blood Institute | Hot Springs | Arkansas | 71913 | Not yet recruiting |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | Recruiting |
| City of Hope | Duarte | California | 91010 | 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 | Not yet 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 | Not yet 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 | Not yet recruiting |
| Kaiser Permanente | Vallejo | California | 94589 | Not yet recruiting |
| Kaiser Permanente Walnut Creek | Walnut Creek | California | 94596 | 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 | Not yet 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 |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | Recruiting |
| Central Georgia Cancer Care | Macon | Georgia | 31210 | Not yet recruiting |
| City of Hope National Medical Center, Atlanta Cancer Center | Newnan | Georgia | 30265 | 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 | Not yet recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | Not yet recruiting |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | 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 Chancellor Center for Oncology | 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 |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center | Milford | Massachusetts | 01757 | Not yet recruiting |
| Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital | South Weymouth | Massachusetts | 02190 | Not yet recruiting |
| Profound Research LLC | Sterling Heights | Michigan | 48314 | Not yet recruiting |
| Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota | 55905 | 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 | Not yet recruiting |
| Sidney Kimmel Cancer Center - Washington Township | Sewell | New Jersey | 08080 | Not yet recruiting |
| Atlantic Health System Overlook Medical Center | Summit | New Jersey | 07901 | Not yet recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Not yet recruiting |
| Messino Cancer Centers | Asheville | North Carolina | 28806 | Not yet 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 |
| Cleveland Clinic Akron General | Akron | Ohio | 44302 | Not yet recruiting |
| Gabrail Cancer Center | Canton | Ohio | 44718 | 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 |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| Thomas Jefferson University - Clinical Research Institute | Philadelphia | Pennsylvania | 19107 | Not yet recruiting |
| Jefferson Hospital Northeast | Philadelphia | Pennsylvania | 19114 | Not yet recruiting |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | Not yet recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Not yet recruiting |
| Sarah Cannon Research Institute SCRI | Nashville | Tennessee | 37203 | Not yet 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 |
| 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 | Not yet 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 206 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 Apr 28, 2026 · Synced May 5, 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.