Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer
Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer (MINIMAX): a Dutch Multicenter Observational Study to Gain Insight in Less and More Invasive Axillary Staging and Treatment in Relation to Oncologic Safety and Quality of Life to Develop Evidence-based Guidelines.
Maastricht University Medical Center
549 participants
Jul 16, 2020
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria7
- 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)
Locations(35)
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NCT04486495