AXillary Surgery After NeoAdjuvant Treatment (NCT04373655) | Clinical Trial Compass
RecruitingNot Applicable
AXillary Surgery After NeoAdjuvant Treatment
Germany3,000 participantsStarted 2020-04-28
Plain-language summary
The optimal surgical axillary staging technique in patients who convert from the clinically positive to clinically negative lymph node status under neoadjuvant therapy (cN+ → ycN0) remains to be clarified. Different strategies (axillary lymph node dissection, sentinel node biopsy, targeted axillary dissection) are currently used in different countries. A prospective analysis comparing these techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible. Therefore, the EUBREAST study group decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy.
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:
* Signed informed consent form
* Primary invasive breast cancer (confirmed by core biopsy)
* cN+
* cT1-4c
* Scheduled for neoadjuvant systemic therapy
* Female / male patients ≥ 18 years old
Exclusion criteria
* Distant metastasis
* Recurrent breast cancer
* Inflammatory breast cancer
* Extramammary breast cancer
* Supraclavicular lymph node metastasis
* Pregnancy
* Less than 4 cycles of NACT administered
* Patients not suitable for surgical treatment
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
Invasive disease-free survival (iDFS)
Timeframe: 5 years
2
Axillary recurrence rate
Timeframe: 3 years
3
Health-related quality of life
Timeframe: 5 years
4
Arm morbidity
Timeframe: 5 years
Trial details
NCT IDNCT04373655
SponsorEuropean Breast Cancer Research Association of Surgical Trialists