Trial Title:
Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
NCT ID:
NCT02271828
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Sentinel lymph node procedure
Description:
Sentinel lymph node procedure according to the Dutch breast cancer guideline
Arm group label:
Sentinel lymph node procedure
Summary:
STUDY AIM To decrease the number of breast cancer patients receiving over treatment of
the axilla, in order to positively influence the axillary morbidity rate and quality of
life.
PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not
inferior to the current axillary staging regimen in clinically node negative breast
cancer patients undergoing breast conserving therapy, in terms of regional recurrence
rate.
HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node
negative breast cancer patients undergoing breast conserving therapy. This will lead to a
decreased axillary morbidity rate, with a non-inferior regional recurrence-,
distant-disease free- and overall survival rates.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female
- Aged 18 years or older
- Pathologically confirmed invasive breast carcinoma
- A clinical T1-2 tumor
- Will be treated with lumpectomy and whole breast radiotherapy
- Clinically node negative status: no signs of axillary lymph node metastases at
physical examination and preoperative axillary ultrasound (or negative
cyto-/histopathology)
- Written informed consent
Exclusion Criteria:
- Clinically node positive pre-operative
- Bilateral breast cancer
- Evidence of metastatic disease
- History of invasive breast cancer
- Previous treatment of the axilla with surgery or radiotherapy (except surgery for
hidradenitis suppurativa or for other superficially located skin lesions, such as
naevi)
- Pregnant or nursing
- Other prior malignancies within the past 5 years (except successfully treated basal
cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in
situ of the ipsilateral or contralateral breast) or unsuccessfully treated
malignancies > 5 years before randomization
- Unable or unwilling to give informed consent
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Maastricht University Medical Centre+
Address:
City:
Maastricht
Zip:
6202 AZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marjolein L Smidt, MD, PhD
Phone:
+31433877477
Investigator:
Last name:
Marjolein L Smidt, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Flevoziekenhuis
Address:
City:
Almere
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Rijnstate
Address:
City:
Arnhem
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Amphia ziekenhuis
Address:
City:
Breda
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Jeroen Bosch ziekenhuis
Address:
City:
Den Bosch
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Haga ziekenhuis
Address:
City:
Den Haag
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Deventer ziekenhuis
Address:
City:
Deventer
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Catharina ziekenhuis
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Maxima Medisch Centrum
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Groene Hart ziekenhuis
Address:
City:
Gouda
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
UMC Groningen
Address:
City:
Groningen
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Spaarne Gasthuis
Address:
City:
Haarlem
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Alrijne
Address:
City:
Leiden
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
St. Antonius ziekenhuis
Address:
City:
Nieuwegein
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Canisius-Wilhelmina ziekenhuis
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Radboud UMC
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Laurentius ziekenhuis
Address:
City:
Roermond
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Diakonessenhuis
Address:
City:
Utrecht
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Zuwehofpoort ziekenhuis
Address:
City:
Woerden
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Isala Klinieken
Address:
City:
Zwolle
Country:
Netherlands
Status:
Recruiting
Start date:
April 2015
Completion date:
April 2027
Lead sponsor:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
Borstkanker Onderzoek Groep
Agency class:
Other
Collaborator:
Agency:
Dutch Cancer Society
Agency class:
Other
Collaborator:
Agency:
Maastricht University
Agency class:
Other
Source:
Maastricht University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02271828
https://www.boogstudycenter.nl/studie/273/2013-08-lumpectomie.html
