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Active, not recruiting Observational

The OPBC-07/microNAC Study

NCT06529302 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2024-05-15
Last updated
2025-01-24

Condition(s) studied

Breast Cancer

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Primary outcome measure(s)

  • 5-year rate of any axillary recurrence — 5 years
    Assessment of the incidence of any axillary recurrence, which is defined as isolated or combined with local or distant recurrence.
  • 5-year rate of isolated axillary recurrence — 5 years
    Assessment of the incidence of isolated axillary recurrence.
  • Comparison of 5-year rate of axillary recurrence in patients treated with and without axillary dissection — 5 years
    The incidence of axillary recurrence is compared between patients that were treated with and without axillary dissection.

Trial sites (84)

FacilityCityRegionStatus
Valleywise Health Medical Center Phoenix Arizona
Cedars-Sinai Medical Center Los Angeles California
University of California San Francisco California
Providence Saint John's Cancer Institute Santa Monica California
University of Miami Coral Gables Florida
Dana-Farber Cancer Institute Boston Massachusetts
University of Michigan Ann Arbor Michigan
Mayo Clinic Rochester Minnesota
NYU Langone Health New York New York
Memorial Sloan Kettering Cancer Center New York New York
Montefiore Medical Center New York New York
University of Rochester Rochester New York
Duke University Durham North Carolina
University of Pennsylvania Philadelphia Pennsylvania
Fox Chase Cancer Center Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
MD Anderson Cancer Center Houston Texas
Swedish Cancer Institute Seattle Washington
University of Washington Seattle Washington
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
Hospital Nossa Senhora das Graças Curitiba Brazil
Hospital Geral de Fortaleza Fortaleza Brazil
Instituto do Cancer do Ceará Fortaleza Brazil
Instituto de Mastologia e Oncologia Goiânia Brazil
Hospital de Câncer Araújo Jorge Goiânia Brazil
Sirio Libanes Hospital São Paulo Brazil
Instituto D'OR de Pesquisa e Ensino São Paulo Brazil
Sir Mortimer B. Davis Jewish General Hospital Montreal Canada
Arturo Lopez Perez Foundation Providencia Chile
Institute of Radiation Medicine Vitacura Chile
Clinical Hospital Center Rijeka Rijeka Croatia
Mansoura oncology center Al Mansurah Egypt
University Hospital Augsburg Augsburg Germany
University Hospital Düsseldorf Düsseldorf Germany
KEM | Clinics Essen-Mitte Essen Germany

+ 44 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06529302 on ClinicalTrials.gov ↗ ← All trials in Canada