The OPBC-07/microNAC Study

NCT06529302 | Active Not Recruiting

• 1 other identifier: 2024-00186; bb24Weber
• Study Type: observational
• Target: 2,000
• Locations: 28 countries
• Sites: 81

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.

Conditions

Breast Cancer

Keywords

Neoadjuvant chemotherapy; Axillary lymph node dissection; Residual micrometastases

Outcome Measures

Primary Outcomes (3)

• 5-year rate of any axillary recurrence

  Assessment of the incidence of any axillary recurrence, which is defined as isolated or combined with local or distant recurrence.

  5 years

• 5-year rate of isolated axillary recurrence

  Assessment of the incidence of isolated axillary recurrence.

  5 years

• Comparison of 5-year rate of axillary recurrence in patients treated with and without axillary dissection

  The incidence of axillary recurrence is compared between patients that were treated with and without axillary dissection.

  5 years

Secondary Outcomes (3)

• Proportion of patients with additional micro- and macrometastases removed by axillary lymph node dissection

  5 years

• 5-year rates of locoregional and any invasive recurrence

  5 years

• Comparison of 5-year rate of locoregional and any invasive recurrence in patients treated with and without axillary lymph node dissection

  5 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study assesses consecutive patients with residual micrometastases after neoadjuvant chemotherapy, treated with or without axillary dissection. The data originate from participating Oncoplastic Breast Consortium (OPBC) centers as well as from the US and Brazil, and have been collect within the clinical routine between 2013 and 2024.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (84)

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California

San Francisco, California, 94158, United States

Location

Providence Saint John's Cancer Institute

Santa Monica, California, 90404, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Sanatorio Modelo Quilmes

Quilmes, B1878, Argentina

Location

Chris O'Brien Lifehouse (COBL)

Sydney, 2050, Australia

Location

Ordensklinikum Linz GmbH

Linz, 4020, Austria

Location

Medical University of Vienna Chirurgie

Vienna, 1090, Austria

Location

Hospital de Base do Distrito Federal

Brasília, 70330-150, Brazil

Location

Sirio Libanes Hospital Brasilia

Brasília, Brazil

Location

Hospital Nossa Senhora das Graças

Curitiba, 80810-040, Brazil

Location

Hospital Geral de Fortaleza

Fortaleza, 60150-160,, Brazil

Location

Instituto do Cancer do Ceará

Fortaleza, 60430-230, Brazil

Location

Instituto de Mastologia e Oncologia

Goiânia, 74110-060, Brazil

Location

Hospital de Câncer Araújo Jorge

Goiânia, 74605-070, Brazil

Location

Sirio Libanes Hospital

São Paulo, 01308-050, Brazil

Location

Instituto D'OR de Pesquisa e Ensino

São Paulo, 01401-002, Brazil

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, H3T 1E2, Canada

Location

Arturo Lopez Perez Foundation

Providencia, 7500921, Chile

Location

Institute of Radiation Medicine

Vitacura, 7630370, Chile

Location

Clinical Hospital Center Rijeka

Rijeka, 51000, Croatia

Location

Mansoura oncology center

Al Mansurah, Egypt

Location

University Hospital Augsburg

Augsburg, 86156, Germany

Location

University Hospital Düsseldorf

Düsseldorf, 40225, Germany

Location

KEM | Clinics Essen-Mitte

Essen, 45136, Germany

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

University Hospital Lübeck

Lübeck, 23562, Germany

Location

University General Hospital of Heraklion

Heraklion, 71110, Greece

Location

Athens Medical Center

Marousi, 151 25, Greece

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Insituto Europeo di Oncologia

Milan, 20141, Italy

Location

University Hospital Federico II

Napoli, 80131, Italy

Location

IOV Padua

Padua, 35128, Italy

Location

Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00136, Italy

Location

Pauls Stradiņš Clinical University Hospital

Riga, LV-1002, Latvia

Location

National Cancer Institute

Vilnius, 08406, Lithuania

Location

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Oslo University Hospital

Oslo, N-0424, Norway

Location

Dow University of Health Sciences

Karachi, Sindh 74200, Pakistan

Location

Hospital Nacional Guillermo Almenara Irigoyen

La Victoria, 13, Peru

Location

Instituto Nacional de Enfermedades Neoplasicas

Surquillo, 15038, Peru

Location

University Hospital Zielona Gora

Zielona Góra, 65-046, Poland

Location

Champalimaud Foundation

Lisbon, 1400-038, Portugal

Location

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, 197758, Russia

Location

AGEL Mammacentrum sv. Agáty

Banská Bystrica, 974 01, Slovakia

Location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

ASAN Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Hospital del Mar d'Investigacions Mèdiques

Barcelona, 08003, Spain

Location

Clinica Universidad de Navarra

Madrid, 28027, Spain

Location

Hospital Universitario La Paz, ía Mamaria

Madrid, 28046, Spain

Location

Capio Saint Göran's Hospital

Stockholm, 112 19, Sweden

Location

Cantonal Hospital Baden

Baden, 5404, Switzerland

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Campus SLB Sonnenhof AG

Bern, 3001, Switzerland

Location

Cantonal Hospital Luzern

Lucerne, 6000, Switzerland

Location

EOC Centro di Senologia della Svizzera Italiana

Lugano, 6962, Switzerland

Location

Tumor und Brustzentrum Ostschweiz

Sankt Gallen, 9016, Switzerland

Location

Cantonal Hospital Winterthur

Winterthur, 8400, Switzerland

Location

Zürich Breast Center

Zurich, 8008, Switzerland

Location

University Hospital Zürich

Zurich, 8091, Switzerland

Location

Gülhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Istanbul University Faculty of Medicine

Fatih, 34093, Turkey (Türkiye)

Location

Marmara University

Istanbul, Turkey (Türkiye)

Location

Zonguldak Bülent Ecevit University

Zonguldak, 67100, Turkey (Türkiye)

Location

Cambridge University Hospitals

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (1)

• Montagna 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Walter Paul Weber, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 31, 2024
• Study Start: May 15, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

US (19); PA (1); CA (1); IL (1); SL (1); AU (1); CR (1); PT (1); ES (3); CH (9); KR (4); CL (2); GR (2); IT (5); RU (1); PE (2); DE (5); NO (1); LA (1); TU (4); PL (1); LI (1); SE (1); GB (1); EG (1); NL (1); AR (1); BR (9)