Trial Review

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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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Florida
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Quilmes
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Austria
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Linz
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Austria
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Wien
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Brazil
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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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Canada
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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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Croatia
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Rijeka
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Cyprus
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Nicosia
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Egypt
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Mansoura
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Germany
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Augsburg
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Germany
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Düsseldorf
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Germany
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Essen
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Germany
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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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Greece
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Marousi
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Greece
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Patras
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Greece
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Thessaloniki
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Israel
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Ramat Gan
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Italy
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Milano
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Italy
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Milan
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Italy
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Napoli
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Italy
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Padova
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Italy
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Pavia
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Italy
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Roma
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Italy
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Trento
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Lithuania
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Vilnius
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Netherlands
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Amsterdam
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Norway
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Oslo
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Pakistan
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Karachi
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Peru
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La Victoria
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Peru
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Surquillo
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Poland
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Zielona Gora
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Portugal
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Lisboa
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Portugal
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Setúbal
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Russian Federation
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Saint Petersburg
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Slovakia
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Banská Bystrica
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Slovakia
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Bratislava
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Slovenia
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Ljubljana
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Spain
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Barcelona
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Spain
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Madrid
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Sweden
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Stockholm
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Sweden
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Uppsala
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Switzerland
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Baden
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Switzerland
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Basel
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Switzerland
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Bellinzona
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Switzerland
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Bern
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Switzerland
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Lugano
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Switzerland
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Luzern
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Switzerland
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St. Gallen
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Switzerland
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Winterthur
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Switzerland
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Zürich
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Tajikistan
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Dushanbe
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Turkey
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Ankara
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Turkey
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Fatih
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Turkey
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Istanbul
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Turkey
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Zonguldak
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United Arab Emirates
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Dubai
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United Kingdom
State/province [75] 0 0
Cambridge
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Glasgow

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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06529302