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Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy

NCT04109079 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1900

Last updated 2026-03-30

No results posted yet for this study

Summary

The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.

Conditions

Interventions

PROCEDURE

Axillary lymph node dissection

Participants will undergo removal of at least level I and II axillary lymph nodes.

RADIATION

Axillary radiotherapy

Axillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.

RADIATION

Breast or chest wall radiotherapy

Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.

Sponsors & Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Amit Goyal, MS, MD, FRCS · Royal Derby Hospital, Derby, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2030-02-28
Completion
2030-02-28

Countries

  • Ireland
  • United Kingdom

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 NCT04109079 on ClinicalTrials.gov