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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Breast Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID: NCT07174336
Run by: Eli Lilly and Company
People needed: 800
Starts: 2025-12-22
Expected to finish: 2033-05-01
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

Good Samaritan Regional Medical Center — Corvallis, Oregon, United States (enrolling)
USO - Texas Oncology — Dallas, Texas, United States (enrolling)
City of Hope National Medical Center, Atlanta Cancer Center — Newnan, Georgia, United States (enrolling)
Atlantic Health System Overlook Medical Center — Summit, New Jersey, United States (enrolling)
Jefferson Hospital Northeast — Philadelphia, Pennsylvania, United States (enrolling)
World Research Link — Baytown, Texas, United States (enrolling)
Providence Medical Foundation — Santa Rosa, California, United States (enrolling)
Mid Florida Hematology and Oncology Center — Orange City, Florida, United States (enrolling)
City of Hope, Chicago — Chicago, Illinois, United States (enrolling)
Sidney Kimmel Cancer Center - Washington Township — Sewell, New Jersey, United States (enrolling)
Thomas Jefferson University - Clinical Research Institute — Philadelphia, Pennsylvania, United States (enrolling)
Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States (enrolling)
Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States (enrolling)
City of Hope — Duarte, California, United States (enrolling)
Profound Research LLC — Oceanside, California, United States (enrolling)
The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States (enrolling)
Clermont Oncology Center — Clermont, Florida, United States (enrolling)
Marin Cancer Care — Greenbrae, California, United States (enrolling)
Summit Cancer Care, PC — Savannah, Georgia, United States (enrolling)
Indiana University Health University Hospital — Indianapolis, Indiana, United States (enrolling)
Jefferson Health - Cherry Hill — Cherry Hill, New Jersey, United States (enrolling)
City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
Oncology Associates of Oregon — Eugene, Oregon, United States (enrolling)
UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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