Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New targeted drug shows promise for Hard-to-Treat breast cancers

NCT ID NCT05307705

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This early-stage study tests a new drug called LOXO-783 in people with advanced breast cancer or other solid tumors that have a specific change in the PIK3CA gene. The main goals are to find the safest dose and check for side effects. About 193 participants will take the drug alone or with other cancer treatments for up to 3 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation) * Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available. * Have stopped all cancer treatment and have recovered from the major side effects * Have adequate organ function, as measured by blood tests * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * Patients must have * Measurable disease \--- Patients with non-breast tumor types must have at least 1 measurable lesion * Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only) * For patients with an estrogen receptor (ER)+ breast cancer diagnosis: * If female, must be postmenopausal * If male, must agree to use hormone suppression * Phase 1a: \-- Dose escalation and backfill patients: * Advanced solid tumor * Patients may have had up to 5 prior regimens for advanced disease * Phase 1b: * Part A: * ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer * Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required * Part B: * ER+/HER2- advanced breast cancer * Patients may have had up to 2 prior regimens for advanced disease. * Part C: * ER+/HER2- advanced breast cancer * Patients may have had up to 5 prior regimens for advanced disease. \---- Prior CDK4/6 inhibitor therapy required. * Have a diagnosis of diabetes mellitus Type 2 * Part D: * Advanced breast cancer * Patients may have had up to 5 prior regimens for advanced disease. * Part E: * Advanced solid tumor * Patients may have had up to 3 prior regimens for advanced disease advanced disease * Part F: * ER+/HER2- advanced breast cancer * Patients may have had up to 5 prior regimens for advanced disease * Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required Exclusion Criteria: * Medical Conditions * Colorectal cancer * Endometrial cancers with specific concurrent oncogenic alterations * A history of known active or suspected * Diabetes mellitus Type 1 or * Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C). * Serious concomitant systemic disorder * Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement. * Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process * Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    RECRUITING

    Nagoya, 464-8681, Japan

  • Asan Medical Center

    NOT_YET_RECRUITING

    Seoul, 5505, South Korea

  • BC Cancer Vancouver

    RECRUITING

    Vancouver, V5Z4E6, Canada

  • Beijing Cancer hospital

    NOT_YET_RECRUITING

    Beijing, 100036, China

  • Cancer Research SA

    NOT_YET_RECRUITING

    Adelaide, 5000, Australia

  • Centre Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Dana-Farber Cancer Institute

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, 200032, China

  • Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • Hospital Arnau de Vilanova Valencia

    RECRUITING

    Valencia, 46015, Spain

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Quironsalud Madrid

    NOT_YET_RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • Hospital Universitari Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Quiron Dexeus

    NOT_YET_RECRUITING

    Barcelona, 08028, Spain

  • ICANS_Institut de Cancerologie Strasbourg Europe

    RECRUITING

    Strasbourg, 67033, France

  • Institut Curie

    NOT_YET_RECRUITING

    Paris, 75248, France

  • Institut Jules Bordet

    NOT_YET_RECRUITING

    Anderlecht, 1070, Belgium

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Saint-Herblain, 44805, France

  • Kyoto University Hospital

    NOT_YET_RECRUITING

    Kyoto, 606-8507, Japan

  • Massachusetts General Hospital

    COMPLETED

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905-0002, United States

  • Mayo Clinic of Scottsdale

    NOT_YET_RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Memorial Sloan Kettering Cancer Center

    COMPLETED

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    RECRUITING

    Chūōku, 104-0045, Japan

  • National Cancer Centre Singapore

    NOT_YET_RECRUITING

    Singapore, 169610, Singapore

  • Peter Maccallum Cancer Institute Erb

    NOT_YET_RECRUITING

    East Melbourne, 3002, Australia

  • Princess Margaret Hospital (Hong Kong)

    NOT_YET_RECRUITING

    Toronto, M5G 2M9, Canada

  • Royal Marsden Hospital (Sutton)

    NOT_YET_RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Royal Marsden NHS Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Samsung Medical Center

    NOT_YET_RECRUITING

    Seoul, 06351, South Korea

  • South Texas Accelerated Research Therapeutics (START)

    NOT_YET_RECRUITING

    San Antonio, Texas, 78229, United States

  • St Vincent's Hospital

    NOT_YET_RECRUITING

    Sydney, 2010, Australia

  • Stanford University Hospital

    RECRUITING

    Stanford, California, 94305, United States

  • Tennessee Oncology PLLC

    COMPLETED

    Nashville, Tennessee, 37203, United States

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    NOT_YET_RECRUITING

    Dallas, Texas, 75246, United States

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Kōtō City, 135-8550, Japan

  • The Third Hospital of Nanchang

    RECRUITING

    Nanchang, 330009, China

  • UCLA Medical Center

    COMPLETED

    Los Angeles, California, 90095, United States

  • UCSF Medical Center at Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390-8884, United States

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    NOT_YET_RECRUITING

    Leuven, 3000, Belgium

  • University of Texas MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Universitätsklinikum Erlangen

    NOT_YET_RECRUITING

    Erlangen, 91054, Germany

  • Washington University Medical School

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Wilmot Cancer Institute

    NOT_YET_RECRUITING

    Rochester, New York, 14642, United States

  • Winship Cancer Center Emory University

    COMPLETED

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.