NCT04373655

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Apr 2020Apr 2030

Study Start

First participant enrolled

April 28, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

9.9 years

First QC Date

April 29, 2020

Last Update Submit

February 27, 2025

Conditions

Breast Cancer

Keywords

breast cancerneoadjuvant chemotherapyaxillary lymph node dissectiontargeted axillary dissectiontarget lymph nodesentinel node biopsy

Outcome Measures

Primary Outcomes (4)

  • Invasive disease-free survival (iDFS)

    iDFS is defined as time from surgery to the first clinical, radiological or histological diagnosis of invasive relapse

    5 years

  • Axillary recurrence rate

    Axillary recurrence is defined as radiological and/or histological diagnosis of tumor recurrence in the axilla

    3 years

  • Health-related quality of life

    Health-related QoL will be assessed with the EORTC Quality of life questionnaires

    5 years

  • Arm morbidity

    Arm morbidity will be assessed with the Lymph IFC questionnaire

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Breast cancer patients with lymph node metastasis undergoing neoadjuvat chemotherapy.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Esslingen

Esslingen am Neckar, Germany

RECRUITING

Related Publications (2)

  • Banys-Paluchowski M, Hartmann S, Basali T, Gasparri ML, de Boniface J, Gentilini OD, Cakmak GK, Ditsch N, Stickeler E, Schlichting E, Rubio I, Peintinger F, Untch M, Mau C, Federspiel FK, Bucher S, Ramaker K, Paluchowski P, Bauer L, Riemer S, Langanke D, Leuf TD, Schnabel J, von Abel E, Solbach C, Ovalle SC, Hilmer K, Bjelic-Radisic V, Stahl N, Sanchez-Mendez JI, Hagen V, Hansen MH, Krawczyk N, Sezen BA, Jursik K, Thill M, Kolberg HC, Reimer T, Ruf F, Wihlfahrt K, Rief A, Berger T, Schmidt E, Tauber N, Frohlich S, Kuhn T. Radar reflectors for marking of target lymph nodes in initially node-positive patients receiving neoadjuvant chemotherapy for breast cancer-a subgroup analysis of the prospective AXSANA (EUBREAST-03) trial. Breast Cancer Res Treat. 2025 May;211(1):203-211. doi: 10.1007/s10549-025-07635-4. Epub 2025 Feb 20.

    PMID: 39976867DERIVED

  • Hartmann S, Banys-Paluchowski M, Stickeler E, de Boniface J, Gentilini OD, Kontos M, Seitz S, Kaltenecker G, Warnberg F, Zetterlund LH, Kolberg HC, Frohlich S, Kuhn T. Applicability of magnetic seeds for target lymph node biopsy after neoadjuvant chemotherapy in initially node-positive breast cancer patients: data from the AXSANA study. Breast Cancer Res Treat. 2023 Dec;202(3):497-504. doi: 10.1007/s10549-023-07100-0. Epub 2023 Sep 8.

    PMID: 37684426DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thorsten Kühn, Prof.

    European Breast Cancer Research Association of Surgical Trialists

    STUDY CHAIR

Central Study Contacts

Thorsten Kühn, Prof.

CONTACT

+49711 3103-3051info@eubreast.com

Maggie Banys-Paluchowski, PD Dr.

CONTACT

m.banys@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 4, 2020

Study Start

April 28, 2020

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

DE(1)