Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.
Who can participate
Age range
18 Years
Sex
ALL
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
. Informed consent
. Tested with EndoPredict within the previous 6 months before inclusion
. Age ≥ 18 years
. Patients with primary invasive breast cancer, Stage I/II
. ER-positive
. HER2-negative
. N0 or N1 (1-3 positive lymph nodes)
. T1 - T3
Exclusion criteria
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.
1This trial is measuring 'distant metastasis free survival' — can you explain what that means for someone with ER-positive, HER2-negative breast cancer, and how the results from this study might eventually influence whether I need chemotherapy alongside hormone therapy?
2Since this trial is actively running but no longer enrolling new patients, is there any way I could still benefit from what researchers are learning, or are there similar studies currently open that I should know about?
3The trial focuses on whether chemotherapy is truly necessary for estrogen receptor-positive, HER2-negative breast cancer — based on where the evidence stands right now, do you think I'm a candidate where chemotherapy adds meaningful benefit, or could endocrine therapy alone be sufficient for my situation?
4This study doesn't have a traditional phase label, which suggests it may be more of an observational or outcomes-focused study rather than a drug trial — does that mean participants weren't being given an experimental treatment, and how does that affect how we should interpret its findings for my care?
5Are there genomic tests, like Oncotype DX, that this trial may be using to guide chemotherapy decisions, and should we be considering one of those tests to help decide my own treatment plan?
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
Distant metastasis free survival
Timeframe: 10 years
Trial details
NCT IDNCT03503799
SponsorNorth Eastern German Society of Gynaecological Oncology