Actively Recruiting
Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer
Led by Maastricht University Medical Center · Updated on 2022-08-24
549
Participants Needed
35
Research Sites
363 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patient with unilateral invasive breast cancer and clinical node positive status (cN1-3)
- Pathologically confirmed positive axillary lymph node
- Planned to receive neoadjuvant chemotherapy with or without immunotherapy, followed by staging and treatment of breast and axilla
You will not qualify if you...
- Clinically node negative breast cancer before neoadjuvant systemic therapy
- Bilateral invasive breast cancer
- Neoadjuvant endocrine therapy
- Presence of distant metastases, including oligometastatic disease
- History of invasive breast cancer
- Other malignancies except basal/squamous cell skin cancer and in situ carcinoma of cervix or breast
- Previous axillary surgery or radiotherapy before neoadjuvant systemic therapy, including sentinel lymph node biopsy prior to therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Actively Recruiting
2
Northwest Clinics
Alkmaar, Netherlands
Actively Recruiting
3
The Netherlands Cancer Institute
Amsterdam, Netherlands
Actively Recruiting
4
Gelre Hospital
Apeldoorn, Netherlands
Actively Recruiting
5
Rijnstate Hospital
Arnhem, Netherlands
Actively Recruiting
6
Red Cross Hospital
Beverwijk, Netherlands
Actively Recruiting
7
Alexander Monro Hospital
Bilthoven, Netherlands
Actively Recruiting
8
Amphia Hospital
Breda, Netherlands
Actively Recruiting
9
Van Weel-Bethesda
Dirksland, Netherlands
Actively Recruiting
10
Slingeland Hospital
Doetinchem, Netherlands
Actively Recruiting
11
Albert Schweitzer Hospital
Dordrecht, Netherlands
Actively Recruiting
12
Gelderse Vallei Hospital
Ede, Netherlands
Actively Recruiting
13
Catharina Hospital
Eindhoven, Netherlands
Actively Recruiting
14
Máxima Medical Center
Eindhoven, Netherlands
Actively Recruiting
15
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
16
Martini Hospital
Groningen, Netherlands
Actively Recruiting
17
Saxenburgh Medical Center
Hardenberg, Netherlands
Actively Recruiting
18
Ziekenhuisgroep Twente
Hengelo, Netherlands
Actively Recruiting
19
Tergooi Hospital
Hilversum, Netherlands
Actively Recruiting
20
Spaarne Gasthuis
Hoofddorp, Netherlands
Actively Recruiting
21
Dijklander Hospital
Hoorn, Netherlands
Actively Recruiting
22
Medical Center Leeuwarden
Leeuwarden, Netherlands
Actively Recruiting
23
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
24
Alrijne Hospital
Leiderdorp, Netherlands
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25
Haaglanden Medical Center
Leidschendam, Netherlands
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26
Maastricht University Medical Center
Maastricht, Netherlands
Actively Recruiting
27
Canisius Wilhelmina Hospital
Nijmegen, Netherlands
Actively Recruiting
28
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
29
Franciscus Gasthuis
Rotterdam, Netherlands
Actively Recruiting
30
Ikazia Hospital
Rotterdam, Netherlands
Actively Recruiting
31
Maasstad Hospital
Rotterdam, Netherlands
Actively Recruiting
32
Spijkenisse Medical Center
Spijkenisse, Netherlands
Actively Recruiting
33
ZorgSaam Hospital
Terneuzen, Netherlands
Actively Recruiting
34
Diakonessenhuis
Utrecht, Netherlands
Actively Recruiting
35
Isala Hospital
Zwolle, Netherlands
Actively Recruiting
Research Team
S
Sabine de Wild, MD
CONTACT
J
Janine Simons, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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