AXillary Surgery After NeoAdjuvant Treatment
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Breast Cancer Research Association of Surgical Trialists
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent form
Primary invasive breast cancer (confirmed by core biopsy)
cN+
cT1-4c
Disqualifiers
Distant metastasis
Recurrent breast cancer
Inflammatory breast cancer
Extramammary breast cancer
Trial population
Breast cancer patients with lymph node metastasis undergoing neoadjuvat chemotherapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Invasive disease-free survival (iDFS)
iDFS is defined as time from surgery to the first clinical, radiological or histological diagnosis of invasive relapse
Time frame
5 years2
Axillary recurrence rate
Axillary recurrence is defined as radiological and/or histological diagnosis of tumor recurrence in the axilla
Time frame
3 years3
Health-related quality of life
Health-related QoL will be assessed with the EORTC Quality of life questionnaires
Time frame
5 years4
Arm morbidity
Arm morbidity will be assessed with the Lymph IFC questionnaire
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
European Breast Cancer Research Association of Surgical Trialists
Lead sponsor
AWOgyn
Collaborator
AGO-B
Collaborator
North Eastern German Society of Gynaecological Oncology
Collaborator
GBG Forschungs GmbH
Collaborator
Claudia von Schilling Foundation for Breast Cancer Research
Collaborator
Ehmann-Stiftung Savognin
Collaborator
Source ClinicalTrials.gov