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 shows promise against Hard-to-Treat breast cancer

NCT ID NCT05963984

Disease control Sponsor: Carrick Therapeutics Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether adding the experimental drug samuraciclib to standard hormone therapy (fulvestrant) works better than fulvestrant alone for people with advanced HR+/HER2- breast cancer. The trial enrolled 60 adults whose cancer had worsened despite prior treatment. Researchers measured how many patients had their cancer shrink or stay stable for at least 24 weeks.

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

60 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 2025

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: * Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer. * Documented objective disease progression while on or within 6 months after the end of the most recent therapy. * Received prior AI in combination with a CDK4/6i as the last therapy * Known TP53 mutation status. * Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks. * Expected life expectancy of \>12 weeks in the judgement of the treating investigator. Exclusion Criteria: * Inflammatory breast cancer. * Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. * More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment. * Inadequate hepatic, renal, and bone marrow function. * Clinically significant cardiovascular disease. * Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease. * Pregnant or breastfeeding women.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for 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 hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer Locally advanced breast cancer Metastatic breast cancer

Contacts and locations

Locations

  • Actualidad Basada en la Investigación del Cáncer

    Guadalajara, Jalisco, 44280, Mexico

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020, Mexico

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, 06100, Mexico

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

    Ankara, 06200, Turkey (Türkiye)

  • Gazi University

    Ankara, 06120, Turkey (Türkiye)

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010, Turkey (Türkiye)

  • Hacettepe Universite Hastaneleri

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Clinico San Carlos

    Madrid, Madrid, Comunidad de, 28040, Spain

  • Hospital Clinico de Valencia

    Valencia, 46010, Spain

  • Hospital Infanta Cristina

    Badajoz, 06080, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria Comunidad de, 39002, Spain

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Vithas Málaga

    Málaga, 29016, Spain

  • I.E.U. Medical Point Hastanesi

    Izmir, 35575, Turkey (Türkiye)

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi

    Istanbul, 34093, Turkey (Türkiye)

  • MD Anderson Cancer Center

    Madrid, 28015, Spain

  • Mfsmc-Hjwci

    Baltimore, Maryland, 21237, United States

  • Nograd Varmegyei Szent Lazar Korhaz

    Salgótarján, Nógrád megye, 3100, Hungary

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000, Mexico

  • Ocala Oncology Center PL DBA Florida Cancer Affiliates

    Ocala, Florida, 34474, United States

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, 08003, Spain

  • Renati Innovation S.A.P.I de C.V

    Guadalajara, Jalisco, 44680, Mexico

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111, United States

  • Semmelweis Egyetem

    Budapest, 1082, Hungary

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania, 19107, United States

  • Soltmed SMO

    Mexico City, Mexico City, 03650, Mexico

  • Szent Borbala Korhaz

    Tatabánya, Komárom-Esztergom, 2800, Hungary

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722, Turkey (Türkiye)

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104, United States

  • Trakya University

    Edirne, 22030, Turkey (Türkiye)

More trials for these conditions

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