Less invasive axillary treatment for breast cancer after chemotherapy
Official title: 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.
Run by Maastricht University Medical Center · NCT04486495 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 549 (estimated) |
| Sponsor | Maastricht University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 35 sites ('s-Hertogenbosch and 34 other locations) |
| Status | Recruiting |
| Started | July 16, 2020 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | August 24, 2022 |
| Trial ID | NCT04486495 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 29 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Neoadjuvant therapy for early triple-negative breast cancer using QL1706 plus chemotherapy guided by response
This study tests if adding QL1706 (a PD-1/CTLA-4 blocker) to chemotherapy before surgery can shrink early triple-negative breast tumors and spare some patients from anthracyclines.
-
Circulating microRNA changes to predict neoadjuvant chemotherapy response in breast cancer.
This will test whether changes in blood microRNA levels before and after chemotherapy can help predict who will have a strong tumor response to neoadjuvant chemotherapy for breast cancer.
-
Reducing sitting time and increasing daily activity during cancer treatment
This project will try a digital self-management program plus physiotherapist support to help people with breast, prostate, or colorectal cancer who are starting neo- or adjuvant treatment sit less and feel better during and after treatment.
-
Skipping axillary surgery when lymph nodes look normal on ultrasound after preoperative chemotherapy
This trial tests whether skipping axillary lymph node surgery after neoadjuvant chemotherapy is safe for breast cancer patients whose lymph nodes look normal on ultrasound.
-
Targeted removal of lymph nodes in breast cancer patients after chemotherapy
This study is testing a new way to remove lymph nodes in breast cancer patients after chemotherapy to see if it works better and is safer than the usual methods.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.