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.

Status: Recruiting
Location: See all (35) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Jeroen Bosch Hospital
RECRUITING
's-hertogenbosch
Northwest Clinics
RECRUITING
Alkmaar
The Netherlands Cancer Institute
RECRUITING
Amsterdam
Gelre Hospital
RECRUITING
Apeldoorn
Rijnstate Hospital
RECRUITING
Arnhem
Red Cross Hospital
RECRUITING
Beverwijk
Alexander Monro Hospital
RECRUITING
Bilthoven
Amphia Hospital
RECRUITING
Breda
Van Weel-Bethesda
RECRUITING
Dirksland
Slingeland Hospital
RECRUITING
Doetinchem
Albert Schweitzer Hospital
RECRUITING
Dordrecht
Gelderse Vallei Hospital
RECRUITING
Ede
Catharina Hospital
RECRUITING
Eindhoven
Máxima Medical Center
RECRUITING
Eindhoven
Medisch Spectrum Twente
RECRUITING
Enschede
Martini Hospital
RECRUITING
Groningen
Saxenburgh Medical Center
RECRUITING
Hardenberg
Ziekenhuisgroep Twente
RECRUITING
Hengelo
Tergooi Hospital
RECRUITING
Hilversum
Spaarne Gasthuis
RECRUITING
Hoofddorp
Dijklander Hospital
RECRUITING
Hoorn
Medical Center Leeuwarden
RECRUITING
Leeuwarden
Leiden University Medical Center
RECRUITING
Leiden
Alrijne Hospital
RECRUITING
Leiderdorp
Haaglanden Medical Center
RECRUITING
Leidschendam
Maastricht University Medical Center
RECRUITING
Maastricht
Canisius Wilhelmina Hospital
RECRUITING
Nijmegen
Erasmus Medical Center
RECRUITING
Rotterdam
Franciscus Gasthuis
RECRUITING
Rotterdam
Ikazia Hospital
RECRUITING
Rotterdam
Maasstad Hospital
RECRUITING
Rotterdam
Spijkenisse Medical Center
RECRUITING
Spijkenisse
ZorgSaam Hospital
RECRUITING
Terneuzen
Diakonessenhuis
RECRUITING
Utrecht
Isala Hospital
RECRUITING
Zwolle
Contact Information
Primary
Sabine de Wild, MD
s.dewild@maastrichtuniversity.nl
+31433881574
Backup
Janine Simons, MD, PhD
j.simons@maastrichtuniversity.nl
Time Frame
Start Date: 2020-07-16
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 549
Authors
Marie-Jeanne T.F.D. Vrancken Peeters, Marjolein L. Smidt, Linetta B. Koppert
Related Therapeutic Areas
Sponsors
Collaborators: The Netherlands Cancer Institute, Erasmus Medical Center
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov