Less invasive axillary treatment for breast cancer after chemotherapy
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.
This study tests if a less invasive way to treat breast cancer after chemotherapy can keep women safe and improve their quality of life compared to more invasive methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 549 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maastricht University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 35 sites ('s-Hertogenbosch and 34 other locations) |
| Trial ID | NCT04486495 on ClinicalTrials.gov |
What this trial studies
This study focuses on women with node positive breast cancer who are receiving neoadjuvant systemic therapy. It aims to evaluate the oncologic safety and quality of life impacts of less invasive axillary staging and treatment compared to more invasive methods. Patients will complete surveys to assess their quality of life at diagnosis, and again at one and five years post-diagnosis. Data will be collected from patient records and analyzed to inform national guidelines and support shared decision-making in treatment options.
Who should consider this trial
Good fit: Ideal candidates are female patients with unilateral invasive breast cancer and clinically node positive axillary lymph nodes who are scheduled for neoadjuvant chemotherapy.
Not a fit: Patients with clinically node negative breast cancer or those who have had prior axillary surgery or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive treatment options for breast cancer patients, improving their quality of life without compromising oncologic safety.
How similar studies have performed: While there is ongoing debate regarding axillary treatment strategies, this study aims to provide new insights, suggesting it may be a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
's-Hertogenbosch and 34 other locations
- Jeroen Bosch Hospital — 's-Hertogenbosch, Netherlands (Recruiting)
- Northwest Clinics — Alkmaar, Netherlands (Recruiting)
- The Netherlands Cancer Institute — Amsterdam, Netherlands (Recruiting)
- Gelre Hospital — Apeldoorn, Netherlands (Recruiting)
- Rijnstate Hospital — Arnhem, Netherlands (Recruiting)
- Red Cross Hospital — Beverwijk, Netherlands (Recruiting)
- Alexander Monro Hospital — Bilthoven, Netherlands (Recruiting)
- Amphia Hospital — Breda, Netherlands (Recruiting)
- Van Weel-Bethesda — Dirksland, Netherlands (Recruiting)
- Slingeland Hospital — Doetinchem, Netherlands (Recruiting)
- Albert Schweitzer Hospital — Dordrecht, Netherlands (Recruiting)
- Gelderse Vallei Hospital — Ede, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- Máxima Medical Center — Eindhoven, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- Martini Hospital — Groningen, Netherlands (Recruiting)
- Saxenburgh Medical Center — Hardenberg, Netherlands (Recruiting)
- Ziekenhuisgroep Twente — Hengelo, Netherlands (Recruiting)
- Tergooi Hospital — Hilversum, Netherlands (Recruiting)
- Spaarne Gasthuis — Hoofddorp, Netherlands (Recruiting)
- Dijklander Hospital — Hoorn, Netherlands (Recruiting)
- Medical Center Leeuwarden — Leeuwarden, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Alrijne Hospital — Leiderdorp, Netherlands (Recruiting)
- Haaglanden Medical Center — Leidschendam, Netherlands (Recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)
- Canisius Wilhelmina Hospital — Nijmegen, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
- Franciscus Gasthuis — Rotterdam, Netherlands (Recruiting)
- Ikazia Hospital — Rotterdam, Netherlands (Recruiting)
- Maasstad Hospital — Rotterdam, Netherlands (Recruiting)
- Spijkenisse Medical Center — Spijkenisse, Netherlands (Recruiting)
- ZorgSaam Hospital — Terneuzen, Netherlands (Recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Recruiting)
- Isala Hospital — Zwolle, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marjolein Smidt, MD, PhD — Maastricht University Medical Center
- Study coordinator: Sabine de Wild, MD
- Email: s.dewild@maastrichtuniversity.nl
- Phone: +31433881574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.