MedTrace Logo

Role of Axillary Lymph Node Dissection for Residual MACROMETASTASES After NEOADJUVANT Chemotherapy in Patients With HER2+ and Triple Negative Breast Cancer: The OPBC-11/MACRONAC Study

NCT07546695 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-05-19

No results posted yet for this study

Summary

In this multicenter retrospective cohort study the aim is to determine the safety of omission of axillary lymph node dissection in patients with TNBC and HER2+ tumors with residual macrometastases (in the SLN/TAD/TAS or MARI node) after NAC.

Conditions

Interventions

OTHER

Data Collection from medical records of from an already existing database "ONCOLOGICAL BREAST SURGERY DATABASE OF THE UNIVERSITY HOSPITAL OF BASEL" which was initiated in 2016.

All trial data are/ have been collected within the clinical routine between 2013 and October 2024. All data will be analyzed descriptively using adequate statistical measures and plots. Clinico-pathological characteristics will be compared between patients treated with and without ALND. Depending on the median follow-up of both cohorts (ALND, no ALND) the 3-year cumulative incidence rates will be compared between ALND and no ALND.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Walter P. Weber, Prof. Dr. med. · Department Breast, Abdomen, Pelvis

  • Giacomo Montagna, MD MPH · Breast Service, Department of Surgery; Memorial Sloan Kettering Cancer Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546695 on ClinicalTrials.gov