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RECRUITING

NCT07174336

PHASE3

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

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2025-12-22

Completion Date

2033-05

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Breast Neoplasms Neoplasm Metastasis

Interventions

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

DRUG

Fulvestrant

Administered intramuscular

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.

Locations (363)

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Community Cancer Institute

Clovis, California, United States

City of Hope

Duarte, California, United States

Epic Care - Emeryville

Emeryville, California, United States

Marin Cancer Care

Greenbrae, California, United States

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

Irvine, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Moores Cancer Center

La Jolla, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Kaiser Permanente Oakland

Oakland, California, United States

Profound Research LLC

Oceanside, California, United States

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

Orange, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Stanford Cancer Center

Palo Alto, California, United States

Kaiser Permanente

Roseville, California, United States

Kaiser Permanente

San Francisco, California, United States

Kaiser Permanente

Santa Clara, California, United States

UCLA Hematology/Oncology - Parkside

Santa Monica, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Kaiser Permanente

Vallejo, California, United States

Kaiser Permanente Walnut Creek

Walnut Creek, California, United States

UCHealth Harmony

Fort Collins, Colorado, United States

Cancer Centers of Colorado St. Mary's Regional Hospital

Grand Junction, Colorado, United States

Banner MD Anderson Cancer Center at North Colorado Medical Center

Greeley, Colorado, United States

Banner MD Anderson Cancer Center at McKee Medical Center

Loveland, Colorado, United States

UConn Health

Farmington, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

AdventHealth Altamonte Springs

Altamonte Springs, Florida, United States

Clermont Oncology Center

Clermont, Florida, United States

Florida Oncology & Hematology

Fort Myers, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, United States

Piedmont Columbus Regional - John B. Amos Cancer Center

Columbus, Georgia, United States

Central Georgia Cancer Care

Macon, Georgia, United States

City of Hope National Medical Center, Atlanta Cancer Center

Newnan, Georgia, United States

Low Country Cancer Care

Savannah, Georgia, United States

Summit Cancer Care, PC

Savannah, Georgia, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

City of Hope, Chicago

Chicago, Illinois, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Endeavor Health

Evanston, Illinois, United States

Accellacare of Duly

Lisle, Illinois, United States

Simmons Cancer Institute at SIU

Springfield, Illinois, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Hematology Oncology of Indiana

Indianapolis, Indiana, United States

Deaconess GI Specialty Center

Newburgh, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Saint Elizabeth Medical Center Edgewood

Edgewood, Kentucky, United States

Our Lady of the Lake RMC

Baton Rouge, Louisiana, United States

New England Cancer Specialists

Westbrook, Maine, United States

American Oncology Partners, PA

Bethesda, Maryland, United States

James M Stockman Cancer Institute

Frederick, Maryland, United States

Mass General Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Profound Research LLC

Sterling Heights, Michigan, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Metro-Minnesota Community Clinical Oncology

Saint Louis Park, Minnesota, United States

North Mississippi Hematology and Oncology Associates

Tupelo, Mississippi, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Jefferson Health - Cherry Hill

Cherry Hill, New Jersey, United States

Sidney Kimmel Cancer Center - Washington Township

Sewell, New Jersey, United States

Atlantic Health System Overlook Medical Center

Summit, New Jersey, United States

NYOH Albany Cancer Center

Albany, New York, United States

New York University (NYU) Brooklyn

Brooklyn, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

NYC Health + Hospitals / Bellevue

New York, New York, United States

Messino Cancer Centers

Asheville, North Carolina, United States

WakeMed Cancer Care - Waverly Hematology & Medical Oncology

Cary, North Carolina, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Carolina Cancer Research Center

Wilson, North Carolina, United States

Sanford Fargo Medical Center

Fargo, North Dakota, United States

Cleveland Clinic Akron General

Akron, Ohio, United States

Gabrail Cancer Center

Canton, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Fairview Hospital

Cleveland, Ohio, United States

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

Columbus, Ohio, United States

Cleveland Clinic - Hillcrest Hospital

Mayfield Heights, Ohio, United States

Good Samaritan Regional Medical Center

Corvallis, Oregon, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Lancaster General Hospital - Ann B Barshinger Cancer Institute

Lancaster, Pennsylvania, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, United States

Jefferson Hospital Northeast

Philadelphia, Pennsylvania, United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

And 263 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (363)