Status:
ACTIVE_NOT_RECRUITING
The OPBC-07/microNAC Study
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Eligibility:
All Genders
18-100 years
Brief 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...
Detailed Description
Chemotherapy before surgery, known as neoadjuvant chemotherapy (NAC), is often used to treat patients with advanced breast cancer or aggressive early-stage breast cancer. Research shows that about one...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06529302
Start Date
May 15 2024
End Date
June 1 2025
Last Update
January 24 2025
Active Locations (84)
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1
Valleywise Health Medical Center
Phoenix, Arizona, United States, 85008
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of California
San Francisco, California, United States, 94158
4
Providence Saint John's Cancer Institute
Santa Monica, California, United States, 90404