Nodal Burden and Nodal Recurrence in Patients With Isolated Tumor Cells After Neoadjuvant Chemotherapy Treated With Axillary Dissection or Nodal Radiation: the OPBC-05/EUBREAST-14R/ICARO Study

NCT06464341 | Completed

• 1 other identifier: 2023-00418: bb23Weber
• Study Type: observational
• Target: 583
• Locations: 18 countries
• Sites: 62

Brief Summary

The purposes of this multicenter retrospective cohort study are to determine the residual nodal burden in patients with isolated tumor cells detected in the SLN or the clipped node after NAC and to determine oncologic outcomes in this group of patients after ALND or nodal RT or observation.

Conditions

Breast Cancer

Keywords

Axillary lymph node dissection; Isolated tumor cells; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (7)

• Number of Axillary Lymph Node Dissection (ALND)

  Evaluation of the number of ALNDs performed

  Day 0

• Number of Tailored Axillary Dissection (TAD)

  Evaluation of the number of TAD performed

  Day 0

• Number of Sentinel Lymph Node Biopsy (SLNB)

  Evaluation of the number of SLNB performed

  one time assessment before surgery

• Number Axillary Radiotherapy

  Evaluation of the number of axillary radiotherapy performed

  Up to 2 years

• Number of additional micrometastases

  Evaluation of the number of additional micrometastases removed by ALND

  Day 0

• Number of additional macrometastases

  Evaluation of the number of additional macrometastases removed by ALND

  Day 0

• Axillary recurrence

  Evaluation of the number of axillary recurrence

  Up to 14 years

Secondary Outcomes (3)

• Regional recurrence

  Up to 14 years

• Locoregional recurrence

  Up to 14 years

• Invasive recurrence

  Up to 14 years

Study Arms (1)

Patients with clinical T1-4 N0-3 breast cancer at diagnosis treated with NAC

This cohort study retrospectively analyzed data from 62 centers in 18 countries, mostly members of the Oncoplastic Breast Consortium (OPBC) network. Patients with clinical T1-4 N0-3 breast cancer at diagnosis treated with neoadjuvant chemotherapy between March 2008 and May 2022 were included if they had isolated tumor cells only. ITCs were defined as clusters of tumor cells ≤0.2 mm or clusters of \<200 cells in a single cross-sectional image, determined by sentinel lymph node biopsy, targeted axillary dissection, or the MARI procedure (marking axillary lymph nodes with radioactive iodine seeds). Excluded: patients with inflammatory breast cancer, stage IV disease at presentation, axillary lymph node dissection as a primary procedure, and neoadjuvant endocrine therapy. Also excluded cases with micrometastases or macrometastases in any sentinel lymph nodes at frozen section or final pathology, and those where ITCs were detected by One Step Nucleic Acid Amplification.

Other: Observational study no intervention

Interventions

Observational study no intervention OTHER

Observational study no intervention

Patients with clinical T1-4 N0-3 breast cancer at diagnosis treated with NAC

Eligibility Criteria

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

Study Population

Consecutive patients will be included. There is no formal sample size calculation

You may qualify if:

• Consecutive patients affected with T1-4 N0-3 breast cancer
• For cN+: Biopsy proven confirmation is required
• For cN0: any axillary staging technique including palpation is allowed
• Residual ITCs in the SLN or clipped node
• At least 1-year follow-up (12/2021 or later depending on the time of data collection)
• For cN0: SLNB with single or dual tracer mapping
• For cN+: SLNB with dual mapping or targeted axillary dissection (TAD: imaging-guided localization of sampled node in combination with SLN procedure with or without dual mapping)
• Underwent TAD/SLNB +/- ALND +/- axillary RT

You may not qualify if:

• Male patients
• Patients with nodal pCR
• Patients with residual nodal micro- or macrometastases
• Stage IV disease at presentation
• Inflammatory breast cancer (T4d) at presentation

Sponsors & Collaborators

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

Study Sites (62)

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center, Samuel Oschin Cancer Institute

Los Angeles, California, 90048, United States

Location

Miami University

Miami, Florida, 33136, 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

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Montefiore Medical Center

New York, New York, 10461, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Duke University

Durham, North Carolina, 27710, 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, 15213, United States

Location

Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98029, United States

Location

University of Washington

Seattle, Washington, 98133, United States

Location

Medical University of Vienna

Vienna, Austria

Location

University Hospital Ghent

Ghent, Belgium

Location

Sirio-Libanes Hospital, Department of Oncology

Brasília, Brazil

Location

Nossa Senhora das Gracias Hospital

Curitiba, Brazil

Location

Instituto de Mastologia e Oncologia

Goiânia, Brazil

Location

Santa Paula Hospital

São Paulo, Brazil

Location

Sirio-Libanes Hospital, Department of Oncology

São Paulo, Brazil

Location

Mc Gill University

Montreal, Canada

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

University Hospital Düsseldorf

Düsseldorf, Germany

Location

KEM Evang. Kliniken Essen-Mitte

Essen, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

University Hospital Schleswig-Holstein Campus Lübeck

Lübeck, Germany

Location

German Breast Group

Neu-Isenburg, Germany

Location

Athens Medical Center

Athens, Greece

Location

Heraklion University Hospital

Heraklion, Greece

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Instituto Nazionale Tumori (IRCCS)

Naples, Italy

Location

University of Naples Federico

Naples, Italy

Location

Veneto Institute of Oncology IRCCS

Padua, Italy

Location

Istituti Clinici Scientifici Maugeri IRCCS,

Pavia, Italy

Location

IRCCS Humanitas Research Hospital

Rozzano, Italy

Location

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Location

University Hospital of Zielona Góra

Zielona Góra, Poland

Location

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Hospital del Mar

Barcelona, Spain

Location

Sahlgrenska University Hospital Gothenburg

Gothenburg, Sweden

Location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Kantonsspital Baden

Baden, Switzerland

Location

Breastcenter Zürich

Zurich, Switzerland

Location

University Hospital Zürich

Zurich, Switzerland

Location

Gülhane Research and Training Hospital

Ankara, Turkey (Türkiye)

Location

Acıbadem Research Instıtute of Senology

Istanbul, Turkey (Türkiye)

Location

Istanbul University Institute of Oncology

Istanbul, Turkey (Türkiye)

Location

Istanbul University, Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Marmara University, School of Medicine

Istanbul, Turkey (Türkiye)

Location

Zonguldak Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

Cambridge University Hospital

Cambridge, United Kingdom

Location

The Royal Marsden Hospital

London, United Kingdom

Location

Related Publications (1)

• Montagna G, Laws A, Ferrucci M, Mrdutt MM, Sun SX, Bademler S, Balbaloglu H, Balint-Lahat N, Banys-Paluchowski M, Barrio AV, Benson J, Bese N, Boughey JC, Boyle MK, Diego EJ, Eden C, Eller R, Goldschmidt M, Hlavin C, Heidinger M, Jelinska J, Karadeniz Cakmak G, Kesmodel SB, King TA, Kuerer HM, Loesch J, Milardi F, Murawa D, Moo TA, Menes TS, Passeri D, Pastoriza JM, Perhavec A, Pislar N, Polidorio N, Rami A, Ryu JM, Schulz A, Sevilimedu V, Ugurlu MU, Uras C, van Hemert A, Wong SM, Yoo TR, Zhang JQ, Karanlik H, Cabioglu N, Peeters MV, Morrow M, Weber WP; ICARO Study Group. Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+): The OPBC-05/ICARO Study. J Clin Oncol. 2025 Mar;43(7):810-820. doi: 10.1200/JCO.24.01052. Epub 2024 Nov 7.

  PMID: 39509672 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 P. Weber, MD

  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: June 12, 2024
• First Posted: June 18, 2024
• Study Start: May 4, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); BE (1); AU (1); SL (1); KR (3); SE (1); NL (1); BR (5); IT (5); CH (4); TU (6); IL (1); ES (1); DE (6); US (20); GR (2); GB (2); CA (1)