Nodal burden and nodal recurrence in patients with isolated tumor cells after
neoadjuvant chemotherapy treated with axillary dissection or axillaryradiation:
the OPBC-05/EUBREAST-14R/ICARO study
Study design: Multicenter retrospective cohort study
Population: Consecutive patients with residual isolated tumor cells after neoadjuvant
chemotherapy treated with either axillary lymph node dissection (ALND), axillary radiation(RT) or observation.
Eligibility:• At least 1-year follow-up (inclusion should end in 12/2021)• For cN0: any axillary staging technique including palpation is allowed• For cN+: cytological or histological confirmation is required. Axillary staging should be
performed with sentinel lymph node (SLNB) with dual mapping or targeted axillary
dissection (TAD: imaging-guided localization of sampled node in combination with SLN
procedure with or without dual mapping)Primary outcomes:• Patterns of treatment (TAD/SLNB +/- ALND +/- axillary RT) by geographic region and overtime• Incidence of additional micro- and macrometastases removed by ALND
• 3-year rate of axillary recurrence
Secondary outcomes:• 3-year rates of any regional, locoregional and any invasive recurrence• To compare 3-year rate of axillary recurrence in ypN0(i+) with ypN0 (historic OPBC-04/EUBREAST-06/OMA control)
List of variables to be collected:• Center• Age (at surgery)• Race/Ethnicity (Asian, Black, Caucasian, Hispanic, other)• cT at presentation• cN0 or cN+ (biopsy-proven) at presentation• if cN+ method of detection (palpable disease vs imaging-detected non-palpable)• Date of surgery• Type of breast surgery: BCT/mastectomy• Type of axillary surgery-SLNB with dual mapping (in cN+ cases) or-TAD (in cN+ cases)- Type of localization (seed/wire/us/tattoo/others)- single or dual mapping?
-SLNB with single tracer (in cN0 cases)• Sampled node clipped y/n- If yes: Clipped node removed y/n/unknown (documented by specimen radiography orpage 1/2

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￼Protokollsynopsis

operative/pathology reports)
Number of SLNs removed
Number of SLNs with ITCs
Detection on frozen section? y/n
Method of detection? H&E or IHC?
ALND y/n
Number of additional LNs removed
Number of additional positive lymph nodes
Size of the largest nodal metastasis found in the ALND specimen: ITCs/micrometastasis/
macrometastasis• Histology (NST/lobular/other)• Breast pCR: yes/no• Residual tumor size in the breast: size (cm)• Tumor grade• Receptor status- ER+ and/or PR+ HER2-;- ER+ and/or PR+/Her2+;- ER-/PR- Her2+;- ER-/PR-/HER2-;• Type of NAC regimen for HER2- (AC-T/AC-t + Carbo/AC-free regimen/other)• Type of NAC regimen for HER2+ (AC-TH/AC-THP/TCHP/other)• Adjuvant capecitabine: yes/no• If HER2+: type of post-surgical anti-HER2 treatment (H/HP/TDM-1)• If HR+: received adjuvant endocrine therapy: yes/no,- if yes: type of endocrine therapy
Radiotherapy: yes/no• Target Volume:
Whole breast irradiation: y/no
Chest wall irradiation: y/no
Regional nodal irradiation y/no•
••••
••
•

Follow-up
Date of last follow up• Recurrence: yes/no• Type of recurrence: local/regional/locoregional/synchronous (regional and distant, localand distant, locoregional and distant)• Type of regional recurrence: axillary only, axillary and supraclavicular or internal
mammary, supraclavicular or internal mammary without axillary• Date of recurrence• Deceased: yes/no• Date of death• Cause of deathpage 2/2

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BASEC-ID 2023-00418 Version 1.0 of 28.02.2023

￼Protokollsynopsis