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Phase 3Recruiting

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

Sponsored by Eli Lilly and Company

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.

Where this study is enrolling (60)

  • Alaska Oncology and Hematology

    Anchorage, Alaska

    Call 907-257-9851

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  • Ironwood Cancer & Research Centers

    Chandler, Arizona

    Call +1 480-821-2838

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  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona

    Call +1 480-515-6296

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  • Genesis Cancer and Blood Institute

    Hot Springs, Arkansas

    Call 501-624-7700

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  • Highlands Oncology Group

    Springdale, Arkansas

    Call 479-872-8130

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Show all 60 locations

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center

    Orange, California

    Call 714-456-8614

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  • UCLA Hematology/Oncology - Parkside

    Santa Monica, California

    Call 310-998-4747

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  • Kaiser Permanente Walnut Creek

    Walnut Creek, California

    Call 707-651-2797

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  • Kaiser Permanente Oakland

    Oakland, California

    Call 707-651-5213

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  • Desert Regional Medical Center

    Palm Springs, California

    Call 760-416-4749

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  • Kaiser Permanente

    San Francisco, California

    Call 707-651-5213

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  • Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine

    Irvine, California

    Call 714-456-8614

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  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California

    Call 323-397-5954

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  • Kaiser Permanente

    Vallejo, California

    Call 707-651-2797

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  • Cancer Centers of Colorado St. Mary's Regional Hospital

    Grand Junction, Colorado

    Call 970-298-7500

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  • UCHealth Harmony

    Fort Collins, Colorado

    Call 970-493-6337

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  • Banner MD Anderson Cancer Center at McKee Medical Center

    Loveland, Colorado

    Call 970-810-3894

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  • Banner MD Anderson Cancer Center at North Colorado Medical Center

    Greeley, Colorado

    Call 970-810-3894

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  • Clermont Oncology Center

    Clermont, Florida

    Call 352-242-1366

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  • Mid Florida Hematology and Oncology Center

    Orange City, Florida

    Call 386-774-1223

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  • Florida Oncology & Hematology

    Fort Myers, Florida

    Call 239-264-7026

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  • Mayo Clinic in Florida

    Jacksonville, Florida

    Call 904-953-2000

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  • Low Country Cancer Care

    Savannah, Georgia

    Call 912-692-2000

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  • Piedmont Columbus Regional - John B. Amos Cancer Center

    Columbus, Georgia

    Call 706-478-7968

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  • Summit Cancer Care, PC

    Savannah, Georgia

    Call 912-651-5771

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  • Central Georgia Cancer Care

    Macon, Georgia

    Call 478-336-5708

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  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii

    Call 808-432-8000

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  • Endeavor Health

    Evanston, Illinois

    Call 847-570-2000

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  • Northwestern Memorial Hospital

    Chicago, Illinois

    Call 312.926.2000

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  • Simmons Cancer Institute at SIU

    Springfield, Illinois

    Call 217-545-8000

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  • University of Iowa

    Iowa City, Iowa

    Call 319-353-6665

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  • American Oncology Partners, PA

    Bethesda, Maryland

    Call 301-571-2016

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  • Dana-Farber Cancer Institute

    Boston, Massachusetts

    Call 617-632-3800

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  • University of Massachusetts Medical School

    Worcester, Massachusetts

    Call 508-856-3216

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  • Metro-Minnesota Community Clinical Oncology

    Saint Louis Park, Minnesota

    Call 651-254-3572

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  • Allina Health Cancer Institute - Abbott Northwestern Hospital

    Minneapolis, Minnesota

    Call 612-863-8716

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  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota

    Call 507-284-2511

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  • Saint Luke's Cancer Institute

    Kansas City, Missouri

    Call 816-932-2677

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  • Oncology Hematology Associates

    Springfield, Missouri

    Call 417-882-4880

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  • Memorial Sloan Kettering Cancer Center

    New York, New York

    Call 646-888-5157

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  • WakeMed Cancer Care - Waverly Hematology & Medical Oncology

    Cary, North Carolina

    Call 919-350-2873

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  • University of North Carolina Medical Center

    Chapel Hill, North Carolina

    Call 919-260-4616

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  • Cleveland Clinic Akron General

    Akron, Ohio

    Call 330-888-4000

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  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T

    Columbus, Ohio

    Call 614-366-1525

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  • Gabrail Cancer Center

    Canton, Ohio

    Call 330-492-3345

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  • Fairview Hospital

    Cleveland, Ohio

    Call 330-888-4000

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  • Cleveland Clinic - Hillcrest Hospital

    Mayfield Heights, Ohio

    Call 330-888-4000

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  • Thomas Jefferson University - Clinical Research Institute

    Philadelphia, Pennsylvania

    Call 215-906-5938

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  • Medical University of South Carolina

    Charleston, South Carolina

    Call 843-792-9300

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  • Nashville General Hospital

    Nashville, Tennessee

    Call 615-341-4383

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  • Oncology Consultants P.A.

    Houston, Texas

    Call 855-827-9525

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  • Parkland Health and Hospital System

    Dallas, Texas

    Call 214-648-4180

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  • The University of Texas MD Anderson Cancer Center

    Houston, Texas

    Call 877-632-6789

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  • Nova Oncology

    McAllen, Texas

    Call 956-234-4400

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  • Houston Methodist Hospital

    Houston, Texas

    Call 713.790.3311

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  • World Research Link

    Baytown, Texas

    Call 833-832-8328

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  • Hendrick Medical Center

    Abilene, Texas

    Call 325-670-7724

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  • UT Southwestern Medical Center

    Dallas, Texas

    Call 214-648-4180

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  • UW Medicine Valley Medical Center

    Renton, Washington

    Call 425-690-3503

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  • ThedaCare Physicians - Appleton North

    Appleton, Wisconsin

    Call 920-364-3600

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.