The OPBC-07/microNAC Study
Running, not enrolling
Conditions studied: Breast Cancer
In brief
The aim of this multicenter retrospective cohort study is to determine the safety of omission of axillary lymph node dissection in patients with residual micrometastases after neoadjuvant chemotherapy.
Key facts
- Study ID
- NCT06529302
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 2000
- Starts
- 2024-05-15
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2025-01-24
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Consecutive women and men aged 18 years or older with a diagnosis of stage I-III breast cancer (any histological and receptor subtype)
- For Clinically Node negative (cN0) at presentation: any axillary staging technique including palpation is allowed. Dual tracer mapping is not required for Sentinel Lymph Node Biopsy (SLNB)
- For Clinically Node positive (cN+) at presentation: Biopsy proven confirmation is required. Staging techniques include: SLNB with dual mapping or targeted axillary dissection (Targeted Axillary Dissection, TAD: imaging-guided localization of sampled node in combination with Sentinel Lymph Node procedure with or without dual mapping) or the Marking Axillary Lymph Nodes with Iodine Seeds (MARI) procedure
- Completed neoadjuvant chemotherapy
- Residual micrometastases detected on SLNB or TAD or MARI (on frozen section or final pathology)
- Concomitant presence of Isolated Tumor Cells (ITCs) and micrometastases in other sentinel lymph nodes is allowed
- Received axillary treatment with completion axillary lymph node dissection (ALND), axillary Radiotherapy (ART), both or none
- At least 1-year follow-up (inclusion should end in May 2023)
- Had surgery at any time point until May 2023 at the latest
- Prior history of stage I-III (not stage IV) breast cancer is allowed
You may not qualify if…
- Did not undergo SLNB/TAD/MARI (e.g., went straight to ALND or ART)
- Presence of ITCs alone or macrometastases on the sentinel nodes (or TAD nodes or MARI node)
- Stage IV disease at presentation
- Inflammatory breast cancer at presentation
- Neoadjuvant endocrine therapy
- Micrometastases detected by One-step nucleic acid amplification (OSNA)
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- University of California — San Francisco, California, United States
- Providence Saint John's Cancer Institute — Santa Monica, California, United States
- University of Miami — Coral Gables, 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
- 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
- MD Anderson Cancer Center — Houston, Texas, United States
- Swedish Cancer Institute — Seattle, Washington, United States
- University of Washington — Seattle, Washington, United States
- Sanatorio Modelo Quilmes — Quilmes, Argentina
- Chris O'Brien Lifehouse (COBL) — Sydney, Australia
- Ordensklinikum Linz GmbH — Linz, Austria
- Medical University of Vienna Chirurgie — Vienna, Austria
- Hospital de Base do Distrito Federal — Brasília, Brazil
- Sirio Libanes Hospital Brasilia — Brasília, Brazil
- Valleywise Health Medical Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.