Status:
ACTIVE_NOT_RECRUITING
Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Borstkanker Onderzoek Groep
Dutch Cancer Society
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
1644 Patients enrolled
Trial Details
Trial ID
NCT02271828
Start Date
April 1 2015
End Date
July 1 2027
Last Update
May 11 2025
Active Locations (22)
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1
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands, 6202 AZ
2
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
3
Flevoziekenhuis
Almere Stad, Netherlands
4
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands