At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LY4064809 (drug), Placebo (drug), Ribociclib (drug), Palbociclib (drug)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- LY4064809 — drug: Administered orally · Placebo — drug: Administered orally · Ribociclib — drug: Administered orally · Palbociclib — drug: Administered orally · Abemaciclib — drug: Administered orally · Anastrozole — drug: Administered orally · Letrozole — drug: Administered orally · Exemestane — drug: Administered orally · Fulvestrant — drug: Administered intramuscular
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 800
- Started
- 2025-12-22
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for breast neoplasms
- • Phase3 - 800 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast neoplasms
Where?
- • Edinburgh - Western General Hospital
- • Huddersfield - Huddersfield Royal Infirmary
- • London - St Bartholomew's Hospital
- • London - Royal Marsden Hospital (Sutton)
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use...
- ✓Have confirmed by testing a sample breast cancer, defined as individuals with
- ✓that has grown locally breast cancer not amenable to curative therapy (for example, surgery) or that has spread disease, and
- ✓hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society...
- ✓HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization...
Who cannot take part
- ✗Have inflammatory or metaplastic breast cancer.
- ✗History of leptomeningeal disease or carcinomatous meningitis.
- ✗Have active bacterial or fungal infection that is not recovered at randomization.
See the full criteria
Where Is This Study? (8 UK sites)
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Huddersfield Royal Infirmary
Huddersfield HD3 3EA, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Royal Marsden Hospital (Sutton)
London SM2 5PT, United Kingdom
Royal Marsden Hospital (Chelsea)
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Derriford Hospital
Plymouth Pl6 8DH, United Kingdom
Worcestershire Royal Hospital
Worcester WR5 1DD, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
