Recruiting
Study Details
Design, interventions, and primary outcomes
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About This Study
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.
Design
Study type: Interventional
Phases: Phase3
Allocation: Randomized
Intervention model: Parallel
Primary purpose: Treatment
Masking/blinding: Double
Interventions / Regimen
- Drug: LY4064809 — Administered orally
- Drug: Placebo — Administered orally
- Drug: Ribociclib — Administered orally
- Drug: Palbociclib — Administered orally
- Drug: Abemaciclib — Administered orally
- Drug: Anastrozole — Administered orally
- Drug: Letrozole — Administered orally
- Drug: Exemestane — Administered orally
Primary Outcomes
- (Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) (Baseline through disease progression or death (Estimated up to 5 years))
- (Part 2): Progression-Free Survival (Baseline to objective progression or death due to any cause (Estimated up to 5 years))
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2025-12-22
Completion: 2033-05
Phase: PHASE3
Status: Recruiting
Start Date: 2025-12-22
Completion: 2033-05
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 800 (ESTIMATED)
Sex: ALL
Volunteers: false
Enrollment: 800 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Eli Lilly and Company
Collaborators: Pfizer
Collaborators: Pfizer
Principal Investigators:
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) (STUDY_DIRECTOR) - Eli Lilly and Company
Contact Information
Study Contact:
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
907-257-9851
Alaska Oncology and Hematology
Interventions
- Drug: LY4064809 — Administered orally
- Drug: Placebo — Administered orally
- Drug: Ribociclib — Administered orally
- Drug: Palbociclib — Administered orally
- Drug: Abemaciclib — Administered orally
Study Locations (364 sites)
Alaska Oncology and Hematology, Anchorage, Alaska 99508 United States
Ironwood Cancer & Research Centers, Chandler, Arizona 85224 United States
St. Joseph's Hospital and Medical Center, Phoenix, Arizona 85004 United States
Mayo Clinic in Arizona - Phoenix, Phoenix, Arizona 85054 United States
The University of Arizona Cancer Center - North Campus, Tucson, Arizona 85719 United States
Genesis Cancer and Blood Institute, Hot Springs, Arkansas 71913 United States
Highlands Oncology Group, Springdale, Arkansas 72762 United States
Community Cancer Institute, Clovis, California 93611 United States
City of Hope, Duarte, California 91010 United States
Epic Care - Emeryville, Emeryville, California 94608 United States
Eligibility 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.