Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT07174336 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Placebo
  • DRUG Palbociclib
  • DRUG Abemaciclib
  • DRUG Ribociclib
  • DRUG LY4064809

Study Locations (20)

California

  • City of Hope — Duarte
  • Marin Cancer Care — Greenbrae
  • Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine — Irvine
  • City of Hope Orange County Lennar Foundation Cancer Center — Irvine
  • Moores Cancer Center — La Jolla
  • USC/Norris Comprehensive Cancer Center — Los Angeles
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Kaiser Permanente Oakland — Oakland
  • Profound Research LLC — Oceanside
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange
  • Desert Regional Medical Center — Palm Springs
  • Stanford Cancer Center — Palo Alto
  • Kaiser Permanente — Roseville
  • Kaiser Permanente — San Francisco
  • UCSF Medical Center at Mission Bay — San Francisco

Arizona

  • Ironwood Cancer & Research Centers — Chandler
  • Mayo Clinic in Arizona - Phoenix — Phoenix
  • The University of Arizona Cancer Center - North Campus — Tucson

Alaska

  • Alaska Oncology and Hematology — Anchorage

Arkansas

  • Highlands Oncology Group — Springdale

Trial Details

FieldValue
Enrollment Target 920 participants
Start Date 2025-12-22
Est. Completion 2033-05
Phase Phase 3

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07174336

The ClinicalTrials.gov registry entry for NCT07174336 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 920 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07174336 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alaska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07174336 about?

NCT07174336 is a clinical study titled "A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)". 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 ...

What is the current status of trial NCT07174336?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 920 participants. The study started on 2025-12-22. Estimated completion is 2033-05.

What conditions does trial NCT07174336 study?

This clinical trial studies the following conditions: Breast Neoplasms, Neoplasm Metastasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07174336?

The interventions under investigation include: Placebo (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), LY4064809 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07174336?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07174336 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial