A Prospective Multicenter Cohort Study to Evaluate Different Surgical Methods of Axillary Staging (sentinel Lymph Node Biopsy, Targeted Axillary Dissection, Axillary Dissection) in Clinically Node-positive Breast Cancer Patients Treated with Neoadjuvant Chemotherapy

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Klinikum Esslingen
RECRUITING
Esslingen Am Neckar
Contact Information
Primary
Thorsten Kühn, Prof.
info@eubreast.com
+49711 3103-3051
Backup
Maggie Banys-Paluchowski, PD Dr.
m.banys@outlook.com
Time Frame
Start Date: 2020-04-28
Estimated Completion Date: 2030-04
Participants
Target number of participants: 3000
Related Therapeutic Areas
Sponsors
Collaborators: Claudia von Schilling Foundation for Breast Cancer Research, AGO-B, Ehmann-Stiftung Savognin, GBG Forschungs GmbH, North Eastern German Society of Gynaecological Oncology, AWOgyn
Leads: European Breast Cancer Research Association of Surgical Trialists

This content was sourced from clinicaltrials.gov

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