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NCT07174336 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Breast Neoplasms and Neoplasm Metastasis, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 920
- Enrollment target
- 20
- Study locations
NCT07174336: Recruiting Phase 3 study of Breast Neoplasms and Neoplasm Metastasis, sponsored by Eli Lilly and Company.
NCT07174336 is a Phase 3 study of Breast Neoplasms and Neoplasm Metastasis that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 920 participants, above the 560-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (64% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07174336, a Phase 3 study of Breast Neoplasms and Neoplasm Metastasis, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 920 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 920 participants |
| Start Date | 2025-12-22 |
| Est. Completion | 2033-05 |
| Phase | Phase 3 |
What NCT07174336 shows while recruiting
NCT07174336 is an interventional study that assigns participants to a tested intervention. The registered 920 participants enrollment target is mid-sized for trials with a published cap, above the 560-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (64% higher).
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.
NCT07174336 names 20 study sites across 4 states, led by California, Arizona, Alaska.
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.
What interventions are being tested in trial NCT07174336?
The interventions under investigation include: Placebo (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), LY4064809 (DRUG).
Who is sponsoring clinical trial NCT07174336?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07174336's enrollment target sits among peer trials
920 14th of 97 higher than 84 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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