Clinical Trial

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

Study acronym: MINIMAX
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-07-22; most recent amendment 2022-08-23.
Trial Details
NCT Number NCT04486495
Lead Sponsor Maastricht University Medical Center
Collaborators: Erasmus Medical Center, The Netherlands Cancer Institute
Conditions Breast Cancer, Neoadjuvant Therapy, Lymph Node Metastases
Enrollment 549 participants
Start Date 2020-07-16
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2022-08-24