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
Completed
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06464341
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 583
- Starts
- 2023-05-04
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2025-01-20
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Consecutive patients affected with T1-4 N0-3 breast cancer
- For cN+: Biopsy proven confirmation is required
- For cN0: any axillary staging technique including palpation is allowed
- Residual ITCs in the SLN or clipped node
- At least 1-year follow-up (12/2021 or later depending on the time of data collection)
- For cN0: SLNB with single or dual tracer mapping
- For cN+: 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)
- Underwent TAD/SLNB +/- ALND +/- axillary RT
You may not qualify if…
- Male patients
- Patients with nodal pCR
- Patients with residual nodal micro- or macrometastases
- Stage IV disease at presentation
- Inflammatory breast cancer (T4d) at presentation
Where it is running
- University of Southern California — Los Angeles, California, United States
- Cedars-Sinai Medical Center, Samuel Oschin Cancer Institute — Los Angeles, California, United States
- Miami University — Miami, Florida, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- NYU Langone Health — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Weill Cornell Medical Center — New York, New York, United States
- Montefiore Medical Center — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Duke University — Durham, North Carolina, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Guthrie Clinic — Sayre, Pennsylvania, United States
- The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
- Swedish Cancer Institute — Seattle, Washington, United States
- University of Washington — Seattle, Washington, 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
- Valleywise Health Medical Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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