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Looking for participantsPhase3

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

Sponsor: Eli Lilly and Company

NCT ID: NCT07174336

View on ClinicalTrials.gov ↗

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.

Breast NeoplasmsNeoplasm Metastasis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

ERreceptor positiveHER2PRstained positivewith a negativePIK3CA

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
Inclusion Criteria: * Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. * If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist. * If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist. * Have histologically or cytologically confirmed breast cancer, defined as individuals with * locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and * hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines * HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally * HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines * Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay. * Have measurable disease or non-measurable, evaluable bone disease * Part 1: * Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. * Up to 1 of these prior systemic treatments may contain chemotherapy * Part 2: * Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. * Individuals who are eligible are either * Population 1 (P1): Endocrine sensitive * newly diagnosed with advanced breast cancer (de novo) * participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET * relapsed with documented evidence of progression greater than (\>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or * Population 2 (P2): Endocrine resistant * relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor. * if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be \>12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy. Exclusion Criteria: * Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter \[mmol/L\]), or requiring insulin. * Have inflammatory or metaplastic breast cancer. * History of leptomeningeal disease or carcinomatous meningitis. * Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization. * Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days. * Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \[mg\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization. * Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment. * Have active bacterial or fungal infection that is not recovered at randomization.

Where Is This Study? (8 UK sites)

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Olga OikonomidouPrincipal Investigator

Huddersfield Royal Infirmary

Huddersfield HD3 3EA, United Kingdom

Recruiting
Site contact (verified)
Heeranand KeswaniPrincipal Investigator

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Peter SchmidPrincipal Investigator

Royal Marsden Hospital (Sutton)

London SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Emma KippsPrincipal Investigator

Royal Marsden Hospital (Chelsea)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Emma KippsPrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
sacha howellPrincipal Investigator

Derriford Hospital

Plymouth Pl6 8DH, United Kingdom

Recruiting
Site contact (verified)
Udaiveer PanwarPrincipal Investigator

Worcestershire Royal Hospital

Worcester WR5 1DD, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Subhadeep BosePrincipal Investigator

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10