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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06529302




Registration number
NCT06529302
Ethics application status
Date submitted
25/07/2024
Date registered
31/07/2024
Date last updated
31/07/2024

Titles & IDs
Public title
The OPBC-07/microNAC Study
Scientific title
Association of Axillary Lymph Node Dissection With Oncological Outcomes in Patients With Residual Micrometastases After Neoadjuvant Chemotherapy: The OPBC-07/microNAC Study
Secondary ID [1] 0 0
2024-00186; bb24Weber
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
5-year rate of any axillary recurrence
Timepoint [1] 0 0
5 years
Primary outcome [2] 0 0
5-year rate of isolated axillary recurrence
Timepoint [2] 0 0
5 years
Primary outcome [3] 0 0
Comparison of 5-year rate of axillary recurrence in patients treated with and without axillary dissection
Timepoint [3] 0 0
5 years
Secondary outcome [1] 0 0
Proportion of patients with additional micro- and macrometastases removed by axillary lymph node dissection
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
5-year rates of locoregional and any invasive recurrence
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Comparison of 5-year rate of locoregional and any invasive recurrence in patients treated with and without axillary lymph node dissection
Timepoint [3] 0 0
5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
University of Sydney - Camperdown
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment outside Australia
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Arizona
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California
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North Carolina
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Quilmes
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Linz
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Wien
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Campinas
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Brazil
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Curitiba
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Brazil
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Goiânia
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Montréal
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Chile
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Providencia
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Chile
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Vitacura
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Rijeka
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Nicosia
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Egypt
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Germany
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Germany
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Germany
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Essen
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Heidelberg
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Germany
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Lübeck
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Greece
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Heraklion
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Patras
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Karachi
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La Victoria
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Dubai
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Cambridge
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Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital, Basel, Switzerland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Memorial Sloan Kettering Cancer Center
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06529302
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Walter Paul Weber, Prof. Dr.
Address 0 0
University Hospital, Basel, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06529302