The OPBC-07/microNAC Study
NCT Number: NCT06529302
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Sponsor: University Hospital, Basel, Switzerland
Collaborators: Memorial Sloan Kettering Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-15
Completion Date: 2025-06
Locations: Valleywise Health Medical Center, Phoenix, Arizona, 85008, United States|Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States|University of Miami, Coral Gables, Florida, 33146, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|University of Rochester, Rochester, New York, 14642, United States|Duke University, Durham, North Carolina, 27708, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|MD Anderson Cancer Center, Houston, Texas, 77030, United States|University of Washington, Seattle, Washington, 98195, United States|Instituto de Oncología Angel H Roffo Universidad de Buenos Aires, Buenos Aires, 1417, Argentina|Sanatorio Modelo Quilmes, Quilmes, B1878, Argentina|Chris O'Brien Lifehouse, Camperdown, NSW 2050, Australia|University of Sydney, Camperdown, NSW 2050, Australia|Ordensklinikum Linz GmbH, Linz, 4020, Austria|Medical University of Vienna Chirurgie, Wien, 1090, Austria|Hospital das Clínicas da Unicamp, Campinas, 13083-888, Brazil|Hospital Nossa Senhora das Graças, Curitiba, 80810-040, Brazil|Instituto de Mastologia e Oncologia, Goiânia, 74110-060, Brazil|Hospital de Câncer Araújo Jorge, Goiânia, 74605-070, Brazil|Sir Mortimer B. Davis, Montréal, H3T 1E2, Canada|Arturo Lopez Perez Foundation, Providencia, 7500921, Chile|Institute of Radiation Medicine, Vitacura, 7630370, Chile|Clinical Hospital Center Rijeka, Rijeka, 51000, Croatia|Oncology Centre, Nicosia, 2012, Cyprus|Mansoura oncology center, Mansoura, Egypt|University Hospital Augsburg, Augsburg, 86156, Germany|University Hospital Düsseldorf, Düsseldorf, 40225, Germany|KEM | Clinics Essen-Mitte, Essen, 45136, Germany|University Hospital Heidelberg, Heidelberg, 69120, Germany|University Hospital Lübeck, Lübeck, 23562, Germany|University General Hospital of Heraklion, Heraklion, 71110, Greece|Hygeia Hospital, Marousi, 151 23, Greece|Athens Medical Center, Marousi, 151 25, Greece|University Hospital of Patras, Patras, 265 04, Greece|Aristotle University of Thessaloniki, Thessaloniki, 541 24, Greece|Sheba Medical Center, Ramat Gan, Israel|Insituto Europeo di Oncologia, Milano, 20141, Italy|San Raffaele Hospital, Milan, 20132, Italy|San Raffaele Scientific Institute, Milan, 20132, Italy|University Hospital Federico II, Napoli, 80131, Italy|IOV Padua, Padova, 35128, Italy|Clinici Scientifici Maugeri IRCCS, Pavia, 27100, Italy|Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, 00136, Italy|Breast Unit Trento, Trento, 38122, Italy|ASAN Medical Center, Seoul, Korea, Republic of|Gangnam Severance Hospital, Seoul, Korea, Republic of|Samsung Medical Center, Seoul, Korea, Republic of|Seoul National University Hospital, Seoul, Korea, Republic of|Pauls Stradiņš Clinical University Hospital, Riga, LV-1002, Latvia|National Cancer Institute, Vilnius, 08406, Lithuania|The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, 1066 CX, Netherlands|Oslo University Hospital, Oslo, N-0424, Norway|Dow University of Health Sciences, Karachi, Sindh 74200, Pakistan|Hospital Nacional Guillermo Almenara Irigoyen, La Victoria, 13, Peru|Instituto Nacional de Enfermedades Neoplasicas, Surquillo, 15038, Peru|University Hospital Zielona Gora, Zielona Gora, 65-046, Poland|Champalimaud Foundation, Lisboa, 1400-038, Portugal|Unidade de Senologia - Unidade Local de Saúde da Arrábida, Setúbal, 2910-446, Portugal|N.N. Petrov National Medical Research Center of Oncology, Saint Petersburg, 197758, Russian Federation|AGEL Mammacentrum sv. Agáty, Banská Bystrica, 974 01, Slovakia|Univerzita Komenského v Bratislave, Bratislava, 814 99, Slovakia|Institute of Oncology Ljubljana, Ljubljana, 1000, Slovenia|Hospital del Mar d'Investigacions Mèdiques, Barcelona, 08003, Spain|Clinica Universidad de Navarra, Madrid, 28027, Spain|MD Anderson Cancer Center Madrid, Madrid, 28033, Spain|Hospital Universitario La Paz, ía Mamaria, Madrid, 28046, Spain|Capio Saint Göran's Hospital, Stockholm, 112 19, Sweden|Uppsala University, Uppsala, 753 10, Sweden|Cantonal Hospital Baden, Baden, 5404, Switzerland|University Hospital Basel, Basel, 4031, Switzerland|EOC Centro di Senologia della Svizzera Italiana, Bellinzona, 6500, Switzerland|Studio Medico Gynesana, Bellinzona, 6500, Switzerland|Campus SLB Sonnenhof AG, Bern, 3001, Switzerland|EOC Centro di Senologia della Svizzera Italiana, Lugano, 6962, Switzerland|Cantonal Hospital Luzern, Luzern, 6000, Switzerland|Tumor und Brustzentrum Ostschweiz, St. Gallen, 9016, Switzerland|Cantonal Hospital Winterthur, Winterthur, 8400, Switzerland|Zürich Breast Center, Zürich, 8008, Switzerland|University Hospital Zürich, Zürich, 8091, Switzerland|Republican Research Center of Oncology, Dushanbe, Tajikistan|Gülhane Training and Research Hospital, Ankara, 06010, Turkey|Istanbul University Faculty of Medicine, Fatih, 34093, Turkey|Acibadem Research Institiute of Senology, Istanbul, 34457, Turkey|Marmara University, Istanbul, Turkey|Zonguldak Bülent Ecevit University, Zonguldak, 67100, Turkey|Mediclinic City Hospital North Wing, Dubai, United Arab Emirates|Cambridge University Hospitals, Cambridge, CB2 0QQ, United Kingdom|Gartnavel General Hospital, Glasgow, G12 0YN, United Kingdom

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.

Primary Outcome Measures: 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 Outcome Measures: Proportion of patients with additional micro- and macrometastases removed by axillary lymph node dissection, Assessment of the proportion of patients with additional micro- and macrometastases that were removed by axillary lymph node dissection., 5 years|5-year rates of locoregional and any invasive recurrence, Assessment of the incidence 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, The incidence of locoregional and any invasive recurrence is compared between patients that were treated with and without axillary lymph node dissection., 5 years