RecruitingPhase 1NCT05307705

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

Sponsor

Eli Lilly and Company

Enrollment

260 participants

Start Date

May 11, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Abemaciclib, a drug called Anastrozole, Exemestane, or Letrozole, and others for people with breast cancer. The study is currently recruiting participants at 50 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLOXO-783

Oral

DRUGFulvestrant

Intramuscular

DRUGImlunestrant

Oral

DRUGAbemaciclib

Oral

DRUGAnastrozole, Exemestane, or Letrozole

Oral

DRUGPaclitaxel

Intravenous

Locations(50)

Mayo Clinic of Scottsdale

Scottsdale, Arizona, United States

UCLA Medical Center

Los Angeles, California, United States

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Stanford University Hospital

Stanford, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Winship Cancer Center Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University Medical School

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Wilmot Cancer Institute

Rochester, New York, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Cancer Research SA

Adelaide, Australia

Peter Maccallum Cancer Institute Erb

East Melbourne, Australia

St Vincent's Hospital

Sydney, Australia

Institut Jules Bordet

Anderlecht, Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Belgium

Princess Margaret Hospital (Hong Kong)

Toronto, Canada

BC Cancer Vancouver

Vancouver, Canada

Beijing Cancer hospital

Beijing, China

The Third Hospital of Nanchang

Nanchang, China

Fudan University Shanghai Cancer Center

Shanghai, China

Centre Leon Berard

Lyon, France

Institut Curie

Paris, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

ICANS_Institut de Cancerologie Strasbourg Europe

Strasbourg, France

Gustave Roussy

Villejuif, France

Universitätsklinikum Erlangen

Erlangen, Germany

National Cancer Center Hospital

Chūōku, Japan

The Cancer Institute Hospital of JFCR

Kōtō City, Japan

Kyoto University Hospital

Kyoto, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

National Cancer Centre Singapore

Singapore, Singapore

Samsung Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitario Quiron Dexeus

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Quironsalud Madrid

Pozuelo de Alarcón, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Arnau de Vilanova Valencia

Valencia, Spain

Royal Marsden NHS Trust

London, United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, United Kingdom

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NCT05307705

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