Clinical trial · Observational
AXillary Surgery After NeoAdjuvant Treatment
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Invasive disease-free survival (iDFS)
- timeFrame
- 5 years
- description
- iDFS is defined as time from surgery to the first clinical, radiological or histological diagnosis of invasive relapse
- measure
- Axillary recurrence rate
- timeFrame
- 3 years
- description
- Axillary recurrence is defined as radiological and/or histological diagnosis of tumor recurrence in the axilla
- measure
- Health-related quality of life
- timeFrame
- 5 years
- description
- Health-related QoL will be assessed with the EORTC Quality of life questionnaires
- measure
- Arm morbidity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDBanys-Paluchowski M, Hartmann S, de Boniface J, Gentilini OD, Ditsch N, Stickeler E, Karadeniz Cakmak G, Hauptmann M, Schroth J, Thill M, di Micco R, Hahn M, Murawa D, Rubio IT, Pinto D, Kontos M, Niinikoski L, Gasparri ML, Nina H, Rebaza LP, Frohlich S, Schmidt E, Wihlfahrt K, Berger T, Basali T, Ruf F, Rief A, Bonci EA, Peintinger F, Schlichting E, Valiyeva Qanimat H, Vanhoeij M, Kadayaprath G, Dostalek L, Kothari A, Perhavec A, Ivanov T, Zippel D, Adamczyk B, Porpiglia M, Gurleyik GM, Untch M, Lux MP, Jursik K, Kolberg HC, Reimer T, Tauber N, Rody A, Matrai Z, Krawczyk N, Thongvitokomarn S, Kuhn T. Marking Techniques for Target Lymph Nodes in Node-Positive Breast Cancer Treated With Neoadjuvant Therapy in the AXSANA/EUBREAST-03/AGO-B-053 Study. J Clin Oncol. 2026 Mar;44(7):575-585. doi: 10.1200/JCO-25-01921. Epub 2026 Jan 21. PMID 41564379
- DERIVEDBanys-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 39976867
- DERIVEDHartmann 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 37684426