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

NCT07174336 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 920

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • Breast Neoplasms
  • Neoplasm Metastasis

Interventions

DRUG

LY4064809

Administered orally

DRUG

Placebo

Administered orally

DRUG

Ribociclib

Administered orally

DRUG

Palbociclib

Administered orally

DRUG

Abemaciclib

Administered orally

DRUG

Anastrozole

Administered orally

DRUG

Letrozole

Administered orally

DRUG

Exemestane

Administered orally

DRUG

Fulvestrant

Administered intramuscular

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2029-05-31
Completion
2033-05-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Japan
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07174336 on ClinicalTrials.gov