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Can a new questionnaire capture what metastatic breast cancer really feels like?

NCT ID NCT07806266

Knowledge-focused Sponsor: University of Leeds Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers across Europe are developing a new questionnaire to better measure the quality of life of women with metastatic breast cancer, a cancer that has spread beyond the breast. The tool aims to capture issues that standard questionnaires miss, such as the impact of ongoing treatment and living with an advanced disease. Women aged 18 and older with this diagnosis will be interviewed to guide the questionnaire's design, ensuring it reflects real patient experiences. The goal is to give doctors a more precise way to assess and address what matters most to each patient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a more accurate tool to measure how metastatic breast cancer affects daily life, helping tailor care to what matters most to patients.
What could go wrong
This is an early-stage development project, not a treatment test. The questionnaire may not capture all experiences or may need further validation before widespread use.

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.

Participants

About 568 people

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

Started

May 2020

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Adult females with Metastatic breast cancer

Ages

18 years and older

Sex

Female participants only

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: * Adult females aged 18 years or over. * Have a diagnosis of MBC (Breast cancer that has spread to another part of the body), including de novo MBC patients. Patients with brain metastases will be included, providing there is no associated major cognitive impairment. * Have received (patients under observation) or currently receiving treatment for MBC, including chemotherapy, hormone therapy, targeted agents (anti-HER2, CDK4/6 inhibitors, mTOR/PIK3CA inhibitors, PARP inhibitors, immune therapy), radiotherapy and combinations. * Conversant in the language of questionnaire administration. * Have the capacity to give informed consent. Exclusion Criteria: * Patients diagnosed with early stage breast cancer. * Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation in interviews. * Patients previously involved in Phase I.

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As listed by the trial registrant

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

Metastatic beast cancer

How to take part

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

  1. The places running it

    22 sites in 14 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

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Lyon, France

  • Centre Hospitalier Universitaire de Saint-Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, France

  • Centre hospitalier de l'Université de Montreal

    NOT_YET_RECRUITING

    Montreal, Canada

  • Champalimaud Clinical Centre

    NOT_YET_RECRUITING

    Lisbon, Portugal

  • Charité - Universitätsmedizin

    NOT_YET_RECRUITING

    Berlin, Germany

  • Comenius University and National Cancer Institute

    NOT_YET_RECRUITING

    Bratislava, Slovakia

  • Ghent University Hospital

    NOT_YET_RECRUITING

    Ghent, Belgium

  • Helios University Hospital

    RECRUITING

    Wuppertal, Germany

  • Istituto Nazionale Tumori

    RECRUITING

    Naples, Italy

  • Kansai Medical University Hospital

    RECRUITING

    Osaka, Japan

  • King Hussein Cancer Center

    RECRUITING

    Amman, Jordan

  • Maria Sklodowska Curie National Research Institute of Oncology

    NOT_YET_RECRUITING

    Warsaw, Poland

  • Mount Vernon Cancer Centre

    RECRUITING

    Rickmansworth, United Kingdom

  • NKI-AVL Amsterdam

    RECRUITING

    Amsterdam, Netherlands

  • National Cancer Centre Hospital

    RECRUITING

    Tokyo, Japan

  • National Centre for Global Health and Medicine

    RECRUITING

    Tokyo, Japan

  • Odette Cancer Center - Sunnybrook Health Sciences Center

    RECRUITING

    Toronto, Canada

  • Royal Navarre Hospital

    RECRUITING

    Pamplona, Spain

  • St James University hospital

    RECRUITING

    Leeds, United Kingdom

  • Tata Memorial Hospital

    NOT_YET_RECRUITING

    Mumbai, India

  • University Hospital of Nimes

    NOT_YET_RECRUITING

    Nîmes, France

  • Veneto Institute of Oncology

    NOT_YET_RECRUITING

    Padova, Italy