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

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…

ClinicalTrials.gov IDNCT04486495

PhaseNot Applicable

Enrollment549

SponsorMaastricht University Medical Center

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Neoadjuvant Therapy, Lymph Node Metastases

About this study

Primary outcomes

Disease free survival (DFS) (5 years)
Breast cancer specific survival (BCSS) (5 years)
Overall survival (OS) (5 years)
Axillary recurrence rate (ARR) (5 years)
Quality of life, as measured by EQ-5D-5L (Baseline, and 1 and 5 years after baseline)
Quality of life, as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR23 (Baseline, and 1 and 5 years after baseline)
Quality of life, as measured by BREAST-Q, which includes the following domains: satisfaction with breasts, psychosocial well being, physical well being, sexual well being. (Baseline, and 1 and 5 years after baseline)

Eligibility information

Inclusion Criteria: * Female patient with unilateral invasive breast cancer and cN1-3 * Pathologically proven positive axillary lymph node * Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla Exclusion Criteria: * Clinically node negative breast cancer before NST * Bilateral invasive breast cancer * Neoadjuvant endocrine therapy * Distant metastases (including oligometastatic disease) * History of invasive breast cancer * Other malignancies, except for basal/squamous cell skin cancer, and in situ carcinoma of the cervix or breast * Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)

Study locations

Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands
Northwest Clinics, Alkmaar, Netherlands
The Netherlands Cancer Institute, Amsterdam, Netherlands
Gelre Hospital, Apeldoorn, Netherlands
Rijnstate Hospital, Arnhem, Netherlands
Red Cross Hospital, Beverwijk, Netherlands
Alexander Monro Hospital, Bilthoven, Netherlands
Amphia Hospital, Breda, Netherlands
Van Weel-Bethesda, Dirksland, Netherlands
Slingeland Hospital, Doetinchem, Netherlands

Showing 10 of 35 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.