Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymph Node Metastases | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Disease free survival (DFS)
- timeFrame
- 5 years
- description
- DFS is defined as the time interval between the date of diagnosis until the date that a patient survives without any signs or symptoms of the disease.
- measure
- Breast cancer specific survival (BCSS)
- timeFrame
- 5 years
- description
- BCSS is defined as the time interval between the date of diagnosis until death from the disease.
- measure
- Overall survival (OS)
- timeFrame
- 5 years
- description
- OS is defined as the time interval between the date of diagnosis until death from any cause.
- measure
- Axillary recurrence rate (ARR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available