NCT07806266 EORTC Metastatic Breast Cancer Module Development
| NCT ID | NCT07806266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leeds |
| Condition | Metastatic Beast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 568 participants |
| Start Date | 2020-05-01 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 568 participants in total. It began in 2020-05-01 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT07806266 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Metastatic Beast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07806266 currently recruiting?
Yes, NCT07806266 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Leeds to inquire about joining.
Where is the NCT07806266 trial being conducted?
This trial is being conducted at Ghent, Belgium, Montreal, Canada, Toronto, Canada, Lyon, France and 11 additional locations.
Who is sponsoring the NCT07806266 clinical trial?
NCT07806266 is sponsored by University of Leeds. The trial plans to enroll 568 participants.
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