Nodal Burden and Nodal Recurrence in Patients With Isolated Tumor Cells After Neoadjuvant Chemotherapy Treated With Axillary Dissection or Nodal Radiation: the OPBC-05/EUBREAST-14R/ICARO Study
NCT Number: NCT06464341
Acronym: ICARO
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Interventions: OTHER: Observational study no intervention
Sponsor: University Hospital, Basel, Switzerland
Collaborators: Memorial Sloan Kettering Cancer Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 583
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-04
Completion Date: 2024-12-31
Locations: Valleywise Health Medical Center, Phoenix, Arizona, 85008, United States|University of Southern California, Los Angeles, California, 90033, United States|Cedars-Sinai Medical Center, Samuel Oschin Cancer Institute, Los Angeles, California, 90048, United States|Miami University, Miami, Florida, 33136, United States|Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|NYU Langone Health, New York, New York, 10016, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Weill Cornell Medical Center, New York, New York, 10065, United States|Montefiore Medical Center, New York, New York, 10461, United States|University of Rochester, Rochester, New York, 14642, United States|Duke University, Durham, North Carolina, 27710, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States|Guthrie Clinic, Sayre, Pennsylvania, 18840, United States|The University of Texas, MD Anderson Cancer Center, Houston, Texas, 77030, United States|Swedish Cancer Institute, Seattle, Washington, 98029, United States|University of Washington, Seattle, Washington, 98133, United States|Medical University of Vienna, Vienna, Austria|University Hospital Ghent, Ghent, Belgium|Sirio-Libanes Hospital, Department of Oncology, Brasília, Brazil|Nossa Senhora das Gracias Hospital, Curitiba, Brazil|Instituto de Mastologia e Oncologia, Goiânia, Brazil|Santa Paula Hospital, São Paulo, Brazil|Sirio-Libanes Hospital, Department of Oncology, São Paulo, Brazil|Mc Gill University, Montréal, Canada|Universitätsklinikum Augsburg, Augsburg, Germany|University Hospital Düsseldorf, Düsseldorf, Germany|KEM Evang. Kliniken Essen-Mitte, Essen, Germany|University Hospital Heidelberg, Heidelberg, Germany|University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany|German Breast Group, Neu Isenburg, Germany|Athens Medical Center, Athens, Greece|Heraklion University Hospital, Heraklion, Greece|Sheba Medical Center, Tel HaShomer, Israel|Instituto Nazionale Tumori (IRCCS), Naples, Italy|University of Naples Federico, Naples, Italy|Veneto Institute of Oncology IRCCS, Padua, Italy|Istituti Clinici Scientifici Maugeri IRCCS,, Pavia, Italy|IRCCS Humanitas Research Hospital, Rozzano, Italy|Asan Medical Center, Seoul, Korea, Republic of|Gangnam Severance Hospital, Seoul, Korea, Republic of|Samsung Medical Center, Seoul, Korea, Republic of|Antoni van Leeuwenhoek, Amsterdam, Netherlands|University Hospital of Zielona Góra, Zielona Góra, Poland|Institute of Oncology Ljubljana, Ljubljana, Slovenia|Hospital del Mar, Barcelona, Spain|Sahlgrenska University Hospital Gothenburg, Gothenburg, Sweden|University Hospital Basel, Basel, Basel-Stadt, 4031, Switzerland|Kantonsspital Baden, Baden, Switzerland|Breastcenter Zürich, Zürich, Switzerland|University Hospital Zürich, Zürich, Switzerland|Gülhane Research and Training Hospital, Ankara, Turkey|Acıbadem Research Instıtute of Senology, Istanbul, Turkey|Istanbul University Institute of Oncology, Istanbul, Turkey|Istanbul University, Faculty of Medicine, Istanbul, Turkey|Marmara University, School of Medicine, Istanbul, Turkey|Zonguldak Bulent Ecevit University, Zonguldak, Turkey|Cambridge University Hospital, Cambridge, United Kingdom|The Royal Marsden Hospital, London, United Kingdom

Summary:
The purposes of this multicenter retrospective cohort study are to determine the residual nodal burden in patients with isolated tumor cells detected in the SLN or the clipped node after NAC and to determine oncologic outcomes in this group of patients after ALND or nodal RT or observation.

Primary Outcome Measures: Number of Axillary Lymph Node Dissection (ALND), Evaluation of the number of ALNDs performed, Day 0|Number of Tailored Axillary Dissection (TAD), Evaluation of the number of TAD performed, Day 0|Number of Sentinel Lymph Node Biopsy (SLNB), Evaluation of the number of SLNB performed, one time assessment before surgery|Number Axillary Radiotherapy, Evaluation of the number of axillary radiotherapy performed, Up to 2 years|Number of additional micrometastases, Evaluation of the number of additional micrometastases removed by ALND, Day 0|Number of additional macrometastases, Evaluation of the number of additional macrometastases removed by ALND, Day 0|Axillary recurrence, Evaluation of the number of axillary recurrence, Up to 14 years
Secondary Outcome Measures: Regional recurrence, Evaluation of the number of regional recurrence, Up to 14 years|Locoregional recurrence, Evaluation of the number of locoregional recurrence, Up to 14 years|Invasive recurrence, Evaluation of the number of invasive recurrence, Up to 14 years