Metastatic Beast CancerNCT07806266
EORTC Metastatic Breast Cancer Module Development
An observational study of Metastatic Beast Cancer, run by University of Leeds at 22 sites in 14 countries.
Trial summary
The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Beast Cancer
- How many people
- 568 participants
- Where
- 22 sitesin 14 countries
- Study dates
- 1 May 2020to 31 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Adult females with Metastatic breast cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 14 countries
France3 sites, 3 recruiting
- Recruiting
Centre Hospitalier Lyon Sud
Lyon
Julien Péron, julien.peron@chu-lyon.fr, julien.peron@chu-lyon.fr
Irina Antochi, irina-elena.antochi@chu-lyon.fr
- Not yet recruiting
University Hospital of Nimes
Nîmes
Frederci Fiteni, frederic.fiteni@chu-nimes.fr, frederic.fiteni@chu-nimes.fr
Astrid Basset, Astrid.BASSET@chu-nimes.fr
- Not yet recruiting
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne
Pauline Corbaux, Pauline.CORBAUX@chu-st-etienne.fr
Wafa Esquis, wafa.esquis@chu-st-etienne.fr
Japan3 sites, 3 recruiting
- Recruiting
Kansai Medical University Hospital
Osaka
Yuichiro Kikawa, bj.u1ro@gmail.com, bj.u1ro@gmail.com
- Recruiting
National Cancer Centre Hospital
Tokyo
Hiroto Ishiki, +81-3-3542-2511, hishiki@ncc.go.jp
Ayumi Saito, aysaito@ncc.go.jp
- Recruiting
National Centre for Global Health and Medicine
Tokyo
Akihiko Shimomura, 81-3-3202-7181(5500), akshimomura@hosp.ncgm.go.jp
Canada2 sites, 2 recruiting
- Not yet recruiting
Centre hospitalier de l'Université de Montreal
Montreal
Jean-Marc Bourque, 514 890-8254, jean-marc.bourque.med@ssss.gouv.qc.ca
- Recruiting
Odette Cancer Center - Sunnybrook Health Sciences Center
Toronto
Edward Chow, edward.chow@sunnybrook.ca, edward.chow@sunnybrook.ca
Jennifer Leigh, 416-480-5000, jennifer.leigh@sunnybrook.ca
Germany2 sites, 2 recruiting
- Not yet recruiting
Charité - Universitätsmedizin
Berlin
Maria Karsten, maria-margarete.karsten@charit, maria-margarete.karsten@charite.de
- Recruiting
Helios University Hospital
Wuppertal
Vesna Bjelic-radisic, +49 202 896 1404 /1434, vesna.bjelic-radisic@helios-gesundheit.de
Nora Nevries, nora.nevries@helios-gesundheit.de
Italy2 sites, 2 recruiting
- Recruiting
Istituto Nazionale Tumori
Naples
Monica Pinto, +39 081 5903581,5903339, monicapinto@iol.it
- Not yet recruiting
Veneto Institute of Oncology
Padova
Elena Groff, elena.groff@iov.veneto.it, elena.groff@iov.veneto.it
United Kingdom2 sites, 2 recruiting
- Recruiting
St James University hospital
Leeds
Galina Velikova, 01132067917, s.reddy@leeds.ac.uk
Susan Hartup, s.hartup@nhs.net
- Recruiting
Mount Vernon Cancer Centre
Rickmansworth
Tara Chalk, 02038262111, tara.chalk@nhs.net
Belgium1 site, 1 recruiting
- Not yet recruiting
Ghent University Hospital
Ghent
Eline Naert, +32 9 332 06 46, eline.naert@uzgent.be
India1 site, 1 recruiting
- Not yet recruiting
Tata Memorial Hospital
Mumbai
Manjunath Nookala, +912268735130/5470, mnookala@actrec.gov.in
Jordan1 site, 1 recruiting
- Recruiting
King Hussein Cancer Center
Amman
Omar Shamieh, 009625300460-1136, oshamieh@khcc.jo
Waleed Alrjoob, wrjoob@khcc.jo
Netherlands1 site, 1 recruiting
- Recruiting
NKI-AVL Amsterdam
Amsterdam
Kelly de Ligt, k.d.ligt@nki.nl, k.d.ligt@nki.nl
Lonneke van de Poll, l.vd.poll@nki.nl
Poland1 site, 1 recruiting
- Not yet recruiting
Maria Sklodowska Curie National Research Institute of Oncology
Warsaw
Katarzyna Pogoda, katarzynapogoda@gazeta.pl, katarzynapogoda@gazeta.pl
Portugal1 site, 1 recruiting
- Not yet recruiting
Champalimaud Clinical Centre
Lisbon
Luzia Travado, luzia.travado@fundacaochampali, luzia.travado@fundacaochampalimaud.pt
Slovakia1 site, 1 recruiting
- Not yet recruiting
Comenius University and National Cancer Institute
Bratislava
Michal Chovanec, michal.chovanec1@gmail.com, michal.chovanec1@gmail.com
Peter Lesko, leskopeter9@gmail.com
Spain1 site, 1 recruiting
- Recruiting
Royal Navarre Hospital
Pamplona
Juan Ignacio Arraras, jiarraras@correo.cop.es, jiarraras@correo.cop.es
About this study
Official title: The European Organisation for Research and Treatment of Cancer: Module Development for Metastatic Breast Cancer (Phase I-IIIa/b)
The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive EORTC questionnaire for assessing the HRQOL of this group. The new module will be used in conjunction with EORTC QLQ-C30 and will provide better measurement of the quality of life issues experienced by women with MBC. Interviews will be conducted with patients from several centres across Europe, guiding the development process in a patient centred way.
- Conditions
- Metastatic Beast Cancer
- Keywords
- quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of females with metastatic breast cancer
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 May 2020
- Primary completion31 Aug 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Beast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galina Velikova, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806266
- Sponsor's protocol ID
- IRAS 264748
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European Organisation for Research and Treatment of Cancer: Module Development for Metastatic Breast Cancer (Phase I-IIIa/b)
- ClinicalTrials.gov ID
- NCT07806266
- Acronym / sponsor ID
- IRAS 264748
- Conditions
- Metastatic Beast Cancer
- Keywords
- quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 568 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive EORTC questionnaire for assessing the HRQOL of this group. The new module will be used in conjunction with EORTC QLQ-C30 and will provide better measurement of the quality of life issues experienced by women with MBC. Interviews will be conducted with patients from several centres across Europe, guiding the development process in a patient centred way.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult females with Metastatic breast cancer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life of females with metastatic breast cancer
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre hospitalier de l'Université de Montreal
Montreal, Canada
Odette Cancer Center - Sunnybrook Health Sciences Center
Toronto, Canada
22 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Beast Cancer, run by University of Leeds at 22 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Japan, Canada, Germany, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of females with metastatic breast cancer (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.