MedTrace Logo

Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer

NCT04486495 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 549

Last updated 2022-08-24

No results posted yet for this study

Summary

Today, the majority of clinically node positive (cN+) breast cancer patients is treated with neoadjuvant systemic therapy (NST). Axillary staging and treatment after NST in cN+ patients are areas of controversy. Patients with a pathological complete response (pCR) of the axillary lymph nodes are not expected to benefit from axillary lymph node dissection (ALND). Hence, less invasive axillary staging procedures are being introduced to avoid unnecessary ALND. However, evidence supporting the safety of replacing ALND by less invasive techniques in terms of oncologic safety and impact on quality of life (QoL) is lacking.

Conditions

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Marjolein Smidt, MD, PhD · Maastricht University Medical Center

  • Marie-Jeanne Vrancken Peeters, MD, PhD · The Netherlands Cancer Institute

  • Linetta Koppert, MD, PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04486495 on ClinicalTrials.gov