Clinical trialNCT07174336RecruitingPhase 3Interventional

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

SponsorEli Lilly and CompanyEnrollment800Breast NeoplasmsNeoplasm Metastasis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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)
Eli Lilly and Company
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

359 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina

Ciprec
Buenos Aires, Argentina
Ezequiel Slutsky
Not, yet, recruiting
Centro Oncologico Korben
Buenos Aires, Argentina
Ernesto Korbenfeld
Not, yet, recruiting
Centro de Investigaciones Medicas Y Desarrollo Lc
Buenos Aires, Argentina
Monica Casalnuovo
Not, yet, recruiting
Focus Cecic
Buenos Aires, Argentina
Danisa Fariña
Not, yet, recruiting
Fundación Respirar
Buenos Aires, Argentina
Christian Fuentes
Not, yet, recruiting
Investigaciones Clinicas Moleculares (icm)
Buenos Aires, Argentina
Nicolas Torressi
Not, yet, recruiting
Organizacion Medica de Investigacion
Buenos Aires, Argentina
Margarita Alfie
Not, yet, recruiting
Instituto de Investigaciones Clínicas Córdoba
Córdoba, Argentina
Santiago Bella
Not, yet, recruiting
Fundación Innovaciencia
Rosario, Argentina
Mariana Queralt
Not, yet, recruiting
Hospital Provincial del Centenario
Rosario, Argentina
Andrea Pastor
Not, yet, recruiting
Coe (centro Oncológico de Excelencia)
San Juan, Argentina
Juan Puig
Not, yet, recruiting
Instituto San Marcos
San Juan, Argentina
Alejandro Roses Videla
Not, yet, recruiting
Go Centro Medico San Nicolás
San Nicolás, Argentina
Vanina Binner
Not, yet, recruiting

Australia

Ballarat Health Services
Ballarat Central, Australia
James Ridgwell
Recruiting
the Prince Charles Hospital
Brisbane, Australia
Kyung Ha (Kathy) You
Recruiting
St Vincent'S Hospital
Darlinghurst, Australia
Elgene Lim
Recruiting
Royal Hobart Hospital
Hobart, Australia
Melanie Wuttke
Not, yet, recruiting
Peter Maccallum Cancer Centre
Melbourne, Australia
Julia Dixon-Douglas
Not, yet, recruiting
Lake Macquarie Private Hospital
Newcastle, Australia
Nicholas Zdenkowski
Recruiting
Macquarie University
North Ryde, Australia
Dhanusha Sabanathan
Recruiting
Goulburn Valley Health
Shepparton, Australia
Arvind Sahu
Recruiting
St. John of God Subiaco Hospital
Subiaco, Australia
Daphne Tsoi
Recruiting
the Townsville Hospital
Townsville, Australia
Joanne Tan
Not, yet, recruiting

Belgium

Institut Jules Bordet
Anderlecht, Belgium
Philippe Aftimos
Not, yet, recruiting
Jessa Ziekenhuis
Hasselt, Belgium
Jeroen Mebis
Not, yet, recruiting
Az Groeninge Campus Kennedylaan
Kortrijk, Belgium
Laure Nuytemans
Not, yet, recruiting
Uz Leuven
Leuven, Belgium
Patrick Neven
Not, yet, recruiting
Chu Ucl Namur/site Sainte Elisabeth
Namur, Belgium
Donatienne Taylor
Not, yet, recruiting
Clinique Saint Pierre
Ottignies, Belgium
Renaud Poncin
Not, yet, recruiting
Az Nikolaas
Sint-Niklaas, Belgium
Ines Deleu
Not, yet, recruiting

Brazil

Fundação Pio Xii - Hospital de Câncer de Barretos
Barretos, Brazil
Ana Suellen Barroso Carneiro
Not, yet, recruiting
Hospital São Domingos
Bequimão, Brazil
Ana Fonseca Alves
Not, yet, recruiting
Centro de Pesquisa Clínica Do Instituto Do Câncer Do Ceará
Fortaleza, Brazil
Jailson de Sousa Oliveira
Not, yet, recruiting
Hospital Araújo Jorge
Goiânia, Brazil
Ruffo Freitas-Junior
Not, yet, recruiting
Hospital Brasilia
Lago Sul, Brazil
Romualdo Barroso-Sousa
Not, yet, recruiting
Hospital de Cancer de Londrina
Londrina, Brazil
Vitor Liutti
Not, yet, recruiting
Instituto Atena de Pesquisa Clinica - Mossoró
Mossoró, Brazil
Stephanie Dantas
Not, yet, recruiting
Liga Norte Riograndense Contra O Câncer
Natal, Brazil
Luciana Aquino Pimentel
Not, yet, recruiting
Futtura Oncology - Clinical Research Hub
Porto Alegre, Brazil
Gustavo Werutsky
Not, yet, recruiting
Hospital São Lucas Da Pucrs
Porto Alegre, Brazil
Fernanda Damian
Not, yet, recruiting

319 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Abemaciclib →Anastrozole →Exemestane →Fulvestrant →LY4064809 →Letrozole →Palbociclib →PlaceboRibociclib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 22 Dec 2025
Primary completion: 31 May 2029
Completion: 31 May 2033
Last update posted: 21 Aug 2026
Registered enrollment: 800
Registry id: NCT07174336

Cross-registrations

EU-CTR / CTIS (EudraCT)2025-522791-92-00

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.