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New drug combo shows promise for tough breast cancer

NCT ID NCT05963997

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new two-drug combination (samuraciclib and elacestrant) in 49 adults with a common type of advanced breast cancer (HR+/HER2-). The goal was to find a safe dose and see if it can slow the cancer's growth. Participants had already tried other treatments and their cancer had gotten worse.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

49 people

The number who actually took part.

Started

Oct 2023

Finished

Mar 2026

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 and ESR1 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.

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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

  • Site 12 - Belfast City Hospital

    Belfast, United Kingdom

  • Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus

    Seattle, Washington, 98122, United States

  • Site 35 - Cleveland Clinic, Taussig Cancer Institute

    Cleveland, Ohio, 44106, United States

  • Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University

    Chicago, Illinois, 60611, United States

  • Site 4 - The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology

    San Antonio, Texas, 78229, United States

  • Site 42 - Dana-Farber Cancer Institute, EDDC

    Boston, Massachusetts, 02215, United States

  • Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, Spain

  • Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location

    L'Hospitalet de Llobregat, Spain

  • Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)

    Madrid, Spain

  • Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro

    Madrid, Spain

  • Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona, Spain

  • Site 65 - Complexo Hospitalario Universitario A Coruña

    A Coruña, Spain

  • Site 66 - Hospital Clinico San Carlos

    Madrid, Spain

  • Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena

    Seville, Spain

  • Site 68 -Hospital Universitario Vall d'Hebron

    Barcelona, Spain

  • Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)

    Pamplona, Spain

  • Site 80 - Centre Jean Bernard, Clinique Victor Hugo

    Le Mans, France

  • Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie

    Bordeaux, France

  • Site 82 - Institut de Cancerologie de Ouest (ICO)

    Saint-Herblain, France

  • Site 83 - Institut Paoli Calmettes (IPC)

    Marseille, France

  • Site 85 - Institut Curie

    Paris, France

More trials for these conditions

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