Improving Quality of Life for Metastatic Breast Cancer Patients
Official title: The European Organisation for Research and Treatment of Cancer: Module Development for Metastatic Breast Cancer (Phase I-IIIa/b)
Run by University of Leeds · NCT07806266 · Data updated 2026-11-12
This project tests a new EORTC quality-of-life questionnaire module for adults with metastatic breast cancer to better measure their day-to-day well-being.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 568 (estimated) |
| Sponsor | University of Leeds Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 22 sites (Ghent and 21 other locations) |
| Status | Recruiting |
| Started | May 1, 2020 |
| Main results expected | August 31, 2028 |
| Study ends | May 31, 2029 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07806266 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (≥18) with metastatic breast cancer, including de novo cases, receiving or having received treatment, fluent in the questionnaire language, and able to consent.
✕Probably not a fit
Patients without metastatic disease, cognitive impairment that affects participation, or those not undergoing current or recent treatment may not benefit from this module.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on developing and validating an HRQOL module for metastatic breast cancer to be used with the EORTC QLQ-C30. It will collect patient input through interviews across several European centers to ensure the tool reflects real-life experiences. The aim is to create a comprehensive module that accurately captures quality of life issues in this population. Adults 18 and older with metastatic disease, including those with brain metastases (if cognition is not impaired), may participate after informed consent. The study does not specify interventions or treatments beyond ongoing or planned therapy.
Why it matters
Potential benefit: If successful, the new questionnaire could improve how quality of life is measured and addressed in metastatic breast cancer care.
How similar studies have gone: Similar HRQOL tools for breast cancer exist, but this module aims to specifically tailor assessment for the metastatic setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Odette Cancer Center - Sunnybrook Health Sciences Center
Toronto, Canada Recruiting -
Centre Hospitalier Lyon Sud
Lyon, France Recruiting -
Helios University Hospital
Wuppertal, Germany Recruiting -
Istituto Nazionale Tumori
Naples, Italy Recruiting -
Kansai Medical University Hospital
Osaka, Japan Recruiting -
National Cancer Centre Hospital
Tokyo, Japan Recruiting
Show 16 more locations
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National Centre for Global Health and Medicine
Tokyo, Japan Recruiting -
King Hussein Cancer Center
Amman, Jordan Recruiting -
NKI-AVL Amsterdam
Amsterdam, Netherlands Recruiting -
Royal Navarre Hospital
Pamplona, Spain Recruiting -
St James University hospital
Leeds, United Kingdom Recruiting -
Mount Vernon Cancer Centre
Rickmansworth, United Kingdom Recruiting -
Ghent University Hospital
Ghent, Belgium Not yet recruiting -
Centre hospitalier de l'Université de Montreal
Montreal, Canada Not yet recruiting -
University Hospital of Nimes
Nîmes, France Not yet recruiting -
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, France Not yet recruiting -
Charité - Universitätsmedizin
Berlin, Germany Not yet recruiting -
Tata Memorial Hospital
Mumbai, India Not yet recruiting -
Veneto Institute of Oncology
Padova, Italy Not yet recruiting -
Maria Sklodowska Curie National Research Institute of Oncology
Warsaw, Poland Not yet recruiting -
Champalimaud Clinical Centre
Lisbon, Portugal Not yet recruiting -
Comenius University and National Cancer Institute
Bratislava, Slovakia Not yet recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.