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 combo therapy aims to control advanced breast cancer

NCT ID NCT06369285

Disease control Sponsor: Puma Biotechnology, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This study tests a drug called alisertib combined with hormone therapy for people with a common type of advanced breast cancer (HR+, HER2-). The cancer has continued to grow despite at least two prior hormone treatments. The goal is to find the best dose of alisertib and see if the combination can shrink tumors or slow the disease. About 150 adults will take part in this phase 2 trial.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 225 people

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

Started

Nov 2024

Expected to finish

Jun 2029

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: * Aged ≥18 years at signing of informed consent. * Pathology-confirmed diagnosis of breast cancer with evidence of recurrent or metastatic disease not amenable to curative therapy. * Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy. * Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting. * HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines. Exclusion Criteria: * Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload. * Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting. Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hormone receptor positive HER-2 negative 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 neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Hormone receptor positive HER-2 negative breast cancer Metastatic breast cancer Recurrent 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

    52 sites in 3 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

  • Alabama Oncology

    RECRUITING

    Birmingham, Alabama, 34235, United States

  • Alliance Cancer Specialists

    RECRUITING

    Horsham, Pennsylvania, 19044, United States

  • Beverly Hills Cancer Center

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Cancer Care Specialists

    RECRUITING

    Reno, Nevada, 89511, United States

  • Cancer Specialists of North Florida

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • City of Hope at Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fundación Instituto Valenciano de Oncología (IVO)

    RECRUITING

    Valencia, 46009, Spain

  • Fundação Champalimaud

    RECRUITING

    Lisbon, 1400-038, Portugal

  • Hospital CUF Descobertas

    RECRUITING

    Lisbon, 1998-018, Portugal

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Clínico de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Dr. Balmis

    RECRUITING

    Alicante, 03010, Spain

  • Hospital San Cecilio

    RECRUITING

    Granada, 18012, Spain

  • Hospital San Pedro de Alcántara

    RECRUITING

    Cáceres, 10003, Spain

  • Hospital Universitario Arnau de Vilanova

    RECRUITING

    Lleida, 25198, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Juan Ramon Jimenez

    RECRUITING

    Huelva, 21005, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de Basurto

    RECRUITING

    Bilbao, 48013, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • Hospital Universitario de Jaén

    RECRUITING

    Jaén, 23007, Spain

  • Instituto Português Oncologia Do Porto

    RECRUITING

    Porto, 4200-072, Portugal

  • Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)

    RECRUITING

    Lisbon, 1099-023, Portugal

  • LA Cancer Network

    RECRUITING

    Los Angeles, California, 90017, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Hospital

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • MemorialCare Orange Coast Medical Center

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Missouri Cancer Associates

    RECRUITING

    Columbia, Missouri, 65201, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Oncology Hematology Associates

    RECRUITING

    Springfield, Missouri, 65807, United States

  • Saint Luke's Cancer Institute

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Taylor Cancer Research Center

    RECRUITING

    Maumee, Ohio, 43537, United States

  • Tennessee Oncology, Greco-Hainsworth Center for Research

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology

    RECRUITING

    Dallas, Texas, 75246, United States

  • The Ohio State University, Stefanie Spielman Comprehensive Breast Center

    RECRUITING

    Columbus, Ohio, 43212, United States

  • The University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • UCLA Department of Medicine - Hematology/Oncology

    RECRUITING

    Los Angeles, California, 90095, United States

  • UNC Hospitals, University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Colorado School of Medicine

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Illinois Cancer Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Minnesota, Masonic Cancer Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh (UPMC)

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • Virginia Cancer Institute

    RECRUITING

    Richmond, Virginia, 23229, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale University, Yale Cancer Center

    WITHDRAWN

    New Haven, Connecticut, 06520, United States

More trials for these conditions

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