Clinical Trials in Canada / NCT06529302
Active, not recruiting
Observational
The OPBC-07/microNAC Study
NCT06529302 · tracked via the Priya Life Science Canada tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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