EORTC Metastatic Breast Cancer Module Development

ClinicalTrials.gov ID

NCT07806266

Lead Sponsor

University of LeedsOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

568Estimated

Last Update Posted

Sep 8, 2026Actual

Start Date

May 1, 2020Actual

Primary Completion Date

Aug 31, 2028Estimated

Completion Date

May 31, 2029Estimated

Official Title

The European Organisation for Research and Treatment of Cancer: Module Development for Metastatic Breast Cancer (Phase I-IIIa/b)

Brief 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 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.

• Metastatic Beast Cancer

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No data available

Eligibility 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.

Observational Model

Cohort

Time Perspective

Cross-Sectional

Lead Sponsor

University of LeedsOTHER

julien.peron@chu-lyon.frjulien.peron@chu-lyon.fr

frederic.fiteni@chu-nimes.frfrederic.fiteni@chu-nimes.fr

maria-margarete.karsten@charite.demaria-margarete.karsten@charit

vesna.bjelic-radisic@helios-gesundheit.de+49 202 896 1404 /1434

mnookala@actrec.gov.in+912268735130/5470

monicapinto@iol.it+39 081 5903581,5903339

elena.groff@iov.veneto.itelena.groff@iov.veneto.it

bj.u1ro@gmail.combj.u1ro@gmail.com

hishiki@ncc.go.jp+81-3-3542-2511

akshimomura@hosp.ncgm.go.jp81-3-3202-7181(5500)

oshamieh@khcc.jo009625300460-1136

k.d.ligt@nki.nlk.d.ligt@nki.nl

luzia.travado@fundacaochampalimaud.ptluzia.travado@fundacaochampali

jiarraras@correo.cop.esjiarraras@correo.cop.es

s.reddy@leeds.ac.uk01132067917

tara.chalk@nhs.net02038262111

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