Follow-up in Early and Locally Advanced Breast Cancer Patients (NCT03859453) | Clinical Trial Compass
CompletedNot Applicable
Follow-up in Early and Locally Advanced Breast Cancer Patients
Belgium, France, Germany830 participantsStarted 2020-10-14
Plain-language summary
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven Early Breast Cancer (EBC) and Locally Advanced Breast Cancer (LABC) patients who have completed their primary treatment (except endocrine therapy), between 12 months and 36 months after the diagnosis.
* Disease-free without any evidence of relapse
* Age ≥ 18 years.
* Ability to understand and fill out questionnaires.
* Written informed consent.
Exclusion Criteria:
* Metastatic breast cancer (defined as secondary spread to other organs, such as bones, lung, liver, mediastinal lymph nodes) or DCIS.
* Other cancer diagnosis in the past 5 years except non-melanotic skin cancer or cervical intraepithelial neoplasia.
* Male breast cancer.
* Patients on maintenance therapy (other than endocrine therapy).
* Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
* Any psychological (including preexisting psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health-related quality of life
Timeframe: 18 months after first patient inclusion
2
Health-related quality of life
Timeframe: 18 months after first patient inclusion
3
Health-related quality of life
Timeframe: 18 months after first patient inclusion
4
Health-related quality of life
Timeframe: 18 months after first patient inclusion
5
Health-related quality of life
Timeframe: 18 months after first patient inclusion
Trial details
NCT IDNCT03859453
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC