EORTC Metastatic Breast Cancer Module Development

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07806266

Enrollment

568

Registered

2026-09-08

Start date

2020-05-01

Completion date

2029-05-31

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Beast Cancer

Keywords

quality of life

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Quality of life of females with metastatic breast cancer	1 month

Countries

Belgium, Canada, France, Germany, India, Italy, Japan, Jordan, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom

Outcome results