Nodal recurrence following axillary downstaging with neoadjuvant chemotherapy
and omission of axillary lymph node dissection (OPBC-04/EUBREAST-06)
Study design: Multicenter retrospective cohort study
Population: Biopsy proven N+ breast cancer who achieved nodal pCR after neoadjuvant
chemotherapy and did not undergo axillary lymph node dissection
Eligibility:
 At least 1-year follow-up (inclusion period until end of 2020)
 Use of sentinel lymph node (SLN) procedure with dual mapping or targeted axillary
dissection (TAD: imaging-guided localization of sampled node in combination withSLN procedure with or without dual mapping) Site must include a minimum of 10 cases
Primary outcome: Rate of nodal recurrence
Secondary outcomes: Rate of local and distant recurrence and overall survival
List of variables to be collected:
 Center Technique used to stage the axilla after NAC:-SLNB y/n
- dual mapping (mandatory in case of SLN only without TAD)
- single mapping (only allowed in case of TAD)
- Imaging-guided localization of sampled node node y/n-Type of imaging:-US only y/n-Type of localization:-wire/seed/tattoo/others-TAD y/n Sampled node clipped y/n- If yes: Clipped node removed y/n/unknown (documented by specimen radiography
or operative/pathology reports)
 Number of negative SLNs
 Number of negative non-SLNs
 Date of surgery
 Age (at surgery) Ethnicity
 cT1
cN
Histology (NST/lobular/other)
Tumor grade
Receptor status- ER pos and/or PR pos HER2neg;- ERneg/PRneg/HER2neg;- ERpos and/or PR pos/Her2pos;-ERneg/ PRneg Her2pos)
 Type of NAC regimen (Taxan/Anthracyclin/Platin containing) Type of anti-HER2 therapy (Trastuzumab alone/Trastuzumab+Pertuzumab/other) Type of breast surgery: BCT/mastectomy Date of surgery
 Breast pCR: yes/no Nodal pCR: yes/no (should be excluded if no) 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 endocrinetherapy
Radiotherapy: yes/no Target Volume:
Whole breast irradiation: y/nThoracic wall irradiation: y/noRegional nodal irradiation y/no
 Date of last follow up
 Recurrence: yes/no Type of recurrence: local/regional/locoregional/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 death2

Local PI

City, Country

Montagna
Mrdutt Mary

Dedes
Paulinelli

MSKCC, NY, USA
Mayo Clinic, Rochester,USABerlin, Germany
Heidelberg, Germany
Vienna, Austria
Zürich, SwitzerlandTicino, Switzerland
Glasgow, United
Kingdom
USZ, Switzerland
Goiania, Brazil

OvalleRocco
Atte Marcelo Chávez
Díaz
Thorsten Kühn
Mathias Fehr

Jens-Uwe Blohmer
Jörg Heil
Florian Fitzal
Christoph TauschFrancesco Meani
Laszlo Romics

Estimated
accrual250
160

Ethicalapprovalyespending

Data generation
finished by
end of Feb 2022
end of March 22

17

yes
yes
yes
pending
pendingyes

end of Feb
end of Feb 22
end of Feb
end of Feb 22

18
20

pendingyes

end of Jan 22
end of Feb 22

IRAM, Chile
Naples, Italy30
10pendingyes

end of Mar 22
end of Feb 22

Lima, Perú29

pending

ethics end of Mar 2213pendingyes

end of Feb 22

Esslingen, Germany
Frauenfeld, Switzerland

401045

Data transferredSupp Mattransferred

to Walter
to Walter

to Walter
to Walter
to Walter toGiacomo

to Walter toGiacomo

to Walter toGiacomo
to Walter

to Walter toGiacomo
to Walter

to Walter toGiacomo

to Walter toGiacomo3

Maggie BanysPaluchowski
DitschAstrid Botty van den
brueleWeberLübeck, Germany

20

yes

Mar 22

Augsburg, Germany
Duke, NC, USA1023

pending
pending

Mar 22end of Dec 21

to Giacomoto GiacomoBasel, Switzerland

34

yes

end of Feb 2022

to Giacomoto Giacomo729

4