A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
Condition(s) studied
Investigational drug(s) / intervention(s)
LY4064809: Administered orally
Placebo: Administered orally
Ribociclib: Administered orally
Palbociclib: Administered orally
Abemaciclib: Administered orally
Anastrozole: Administered orally
Letrozole: Administered orally
Exemestane: Administered orally
Fulvestrant: Administered intramuscular
Study 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. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
Eligibility
Primary outcome measure(s)
- (Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) — Baseline through disease progression or death (Estimated up to 5 years)
As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 - (Part 2): Progression-Free Survival — Baseline to objective progression or death due to any cause (Estimated up to 5 years)
Investigator-assessed
Trial sites (363)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Oncology and Hematology | Anchorage | Alaska | Not Yet Recruiting |
| Ironwood Cancer & Research Centers | Chandler | Arizona | Recruiting |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | Not Yet Recruiting |
| Mayo Clinic in Arizona - Phoenix | Phoenix | Arizona | Not Yet Recruiting |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | Recruiting |
| Genesis Cancer and Blood Institute | Hot Springs | Arkansas | Not Yet Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | Recruiting |
| Community Cancer Institute | Clovis | California | Not Yet Recruiting |
| City of Hope | Duarte | California | Recruiting |
| Epic Care - Emeryville | Emeryville | California | Recruiting |
| Marin Cancer Care | Greenbrae | California | Recruiting |
| Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine | Irvine | California | Not Yet Recruiting |
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | Recruiting |
| Moores Cancer Center | La Jolla | California | Not Yet Recruiting |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | Not Yet Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Not Yet Recruiting |
| Kaiser Permanente Oakland | Oakland | California | Not Yet Recruiting |
| Profound Research LLC | Oceanside | California | Recruiting |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center | Orange | California | Not Yet Recruiting |
| Desert Regional Medical Center | Palm Springs | California | Not Yet Recruiting |
| Stanford Cancer Center | Palo Alto | California | Not Yet Recruiting |
| Kaiser Permanente | Roseville | California | Not Yet Recruiting |
| Kaiser Permanente | San Francisco | California | Not Yet Recruiting |
| Kaiser Permanente | Santa Clara | California | Not Yet Recruiting |
| UCLA Hematology/Oncology - Parkside | Santa Monica | California | Not Yet Recruiting |
| Providence Medical Foundation | Santa Rosa | California | Recruiting |
| Kaiser Permanente | Vallejo | California | Not Yet Recruiting |
| Kaiser Permanente Walnut Creek | Walnut Creek | California | Not Yet Recruiting |
| UCHealth Harmony | Fort Collins | Colorado | Not Yet Recruiting |
| Cancer Centers of Colorado St. Mary's Regional Hospital | Grand Junction | Colorado | Not Yet Recruiting |
| Banner MD Anderson Cancer Center at North Colorado Medical Center | Greeley | Colorado | Not Yet Recruiting |
| Banner MD Anderson Cancer Center at McKee Medical Center | Loveland | Colorado | Not Yet Recruiting |
| UConn Health | Farmington | Connecticut | Not Yet Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| AdventHealth Altamonte Springs | Altamonte Springs | Florida | Not Yet Recruiting |
| Clermont Oncology Center | Clermont | Florida | Recruiting |
| Florida Oncology & Hematology | Fort Myers | Florida | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | Not Yet Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami | Florida | Not Yet Recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | Recruiting |
+ 323 more sites — see the full list on the official registry below.
On this site
📄 Kisqali (ribociclib) drug profile → 📄 Ibrance (palbociclib) drug profile → 📄 Verzenio (abemaciclib) drug profile →More Eli Lilly and Company trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07174336 on ClinicalTrials.gov ↗ ← All trials in South Korea