Clinical trial · Observational
The OPBC-07/microNAC Study
Association of Axillary Lymph Node Dissection With Oncological Outcomes in Patients With Residual Micrometastases After Neoadjuvant Chemotherapy: The OPBC-07/microNAC Study
NCT06529302CI-TRIAL-00085048active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- 5-year rate of any axillary recurrence
- timeFrame
- 5 years
- description
- Assessment of the incidence of any axillary recurrence, which is defined as isolated or combined with local or distant recurrence.
- measure
- 5-year rate of isolated axillary recurrence
- timeFrame
- 5 years
- description
- Assessment of the incidence of isolated axillary recurrence.
- measure
- Comparison of 5-year rate of axillary recurrence in patients treated with and without axillary dissection
- timeFrame
- 5 years
- description
- The incidence of axillary recurrence is compared between patients that were treated with and without axillary dissection.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDMontagna G, Alvarado M, Myers S, Mrdutt MM, Sun SX, Sevilimedu V, Barrio AV, van den Bruele AB, Boughey JC, Boyle MK, Crown A, Kesmodel SB, King TA, Kuerer HM, Leisha EC, Moo TA, Weiss A, Williams AD, Parmar P, Diskin B, Hlavin C, Diego EJ, Polidorio N, Abdelwahab K, Banys-Paluchowski M, Kurzeder C, Heidinger M, Goldschmidt M, Schulz A, Heil J, Karadeniz Cakmak G, Pislar N, Riis M, Prakash I, Ovalle V, Ugurlu MU, Franceschini G, Sergeevich EA, Morales J, Lee HB, Galimberti V, Ahn SG, Ryu JM, Muslumanoglu M, Cabioglu N, Yoo TR, Vrancken Peeters MJ, Ferrucci M, Morrow M, Weber WP; microNAC Study Group. Oncological outcomes with and without axillary lymph node dissection in patients with residual micrometastases after neoadjuvant chemotherapy (OPBC-07/microNAC): an international, retrospective cohort study. Lancet Oncol. 2026 Jan;27(1):57-67. doi: 10.1016/S1470-2045(25)00598-4. PMID 41449148