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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
24/01/2025

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 (COBL) - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Quilmes
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Brazil
State/province [15] 0 0
Brasilia
Country [16] 0 0
Brazil
State/province [16] 0 0
Curitiba
Country [17] 0 0
Brazil
State/province [17] 0 0
Fortaleza
Country [18] 0 0
Brazil
State/province [18] 0 0
Goiânia
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
Montréal
Country [21] 0 0
Chile
State/province [21] 0 0
Providencia
Country [22] 0 0
Chile
State/province [22] 0 0
Vitacura
Country [23] 0 0
Croatia
State/province [23] 0 0
Rijeka
Country [24] 0 0
Egypt
State/province [24] 0 0
Mansoura
Country [25] 0 0
Germany
State/province [25] 0 0
Augsburg
Country [26] 0 0
Germany
State/province [26] 0 0
Düsseldorf
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Germany
State/province [28] 0 0
Heidelberg
Country [29] 0 0
Germany
State/province [29] 0 0
Lübeck
Country [30] 0 0
Greece
State/province [30] 0 0
Heraklion
Country [31] 0 0
Greece
State/province [31] 0 0
Marousi
Country [32] 0 0
Israel
State/province [32] 0 0
Ramat Gan
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Napoli
Country [35] 0 0
Italy
State/province [35] 0 0
Padova
Country [36] 0 0
Italy
State/province [36] 0 0
Pavia
Country [37] 0 0
Italy
State/province [37] 0 0
Roma
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Seoul
Country [39] 0 0
Latvia
State/province [39] 0 0
Riga
Country [40] 0 0
Lithuania
State/province [40] 0 0
Vilnius
Country [41] 0 0
Netherlands
State/province [41] 0 0
Amsterdam
Country [42] 0 0
Norway
State/province [42] 0 0
Oslo
Country [43] 0 0
Pakistan
State/province [43] 0 0
Karachi
Country [44] 0 0
Peru
State/province [44] 0 0
La Victoria
Country [45] 0 0
Peru
State/province [45] 0 0
Surquillo
Country [46] 0 0
Poland
State/province [46] 0 0
Zielona Gora
Country [47] 0 0
Portugal
State/province [47] 0 0
Lisboa
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Saint Petersburg
Country [49] 0 0
Slovakia
State/province [49] 0 0
Banská Bystrica
Country [50] 0 0
Slovenia
State/province [50] 0 0
Ljubljana
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Sweden
State/province [53] 0 0
Stockholm
Country [54] 0 0
Switzerland
State/province [54] 0 0
Baden
Country [55] 0 0
Switzerland
State/province [55] 0 0
Basel
Country [56] 0 0
Switzerland
State/province [56] 0 0
Bern
Country [57] 0 0
Switzerland
State/province [57] 0 0
Lugano
Country [58] 0 0
Switzerland
State/province [58] 0 0
Luzern
Country [59] 0 0
Switzerland
State/province [59] 0 0
St. Gallen
Country [60] 0 0
Switzerland
State/province [60] 0 0
Winterthur
Country [61] 0 0
Switzerland
State/province [61] 0 0
Zürich
Country [62] 0 0
Turkey
State/province [62] 0 0
Ankara
Country [63] 0 0
Turkey
State/province [63] 0 0
Fatih
Country [64] 0 0
Turkey
State/province [64] 0 0
Istanbul
Country [65] 0 0
Turkey
State/province [65] 0 0
Zonguldak
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Cambridge

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