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RecruitingNCT07806266Updated Sep 8, 2026

EORTC Metastatic Breast Cancer Module Development

An observational study in Metastatic Beast Cancer, sponsored by University of Leeds. Recruiting at 22 sites in 14 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of Leeds · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
568
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Metastatic Beast Cancer

Keywords

  • quality of life
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Adult females with Metastatic breast cancer

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

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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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
568 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Quality of life of females with metastatic breast cancer

    Time frame: 1 month

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Study locations

12 of 22 sites recruiting
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Registry details

Key details

Study ID
NCT07806266
Lead sponsor
University of Leeds
Responsible party
Galina Velikova (Professor Galina Velikova, University of Leeds) — Principal investigator
First posted
Sep 8, 2026
Start date
May 1, 2020
Primary completion
Aug 31, 2028 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Sep 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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