Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
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ClinicalTrials.gov Identifier: NCT02271828 |
Recruitment Status :
Recruiting
First Posted : October 22, 2014
Last Update Posted : May 4, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Neoplasms | Procedure: Sentinel lymph node procedure | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1644 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up. |
Study Start Date : | April 2015 |
Estimated Primary Completion Date : | April 2027 |
Estimated Study Completion Date : | April 2027 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sentinel lymph node procedure
Sentinel lymph node procedure according to the Dutch breast cancer guideline
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Procedure: Sentinel lymph node procedure
Sentinel lymph node procedure according to the Dutch breast cancer guideline |
No Intervention: No sentinel lymph node procedure
No sentinel lymph node procedure
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- Regional recurrence rate [ Time Frame: Up to ten years ]Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271828
Contact: Marjolein L Smidt, MD, PhD | +31433877477 |

Principal Investigator: | Marjolein L Smidt, MD, PhD | Maastricht University Medical Centre, Maastricht, the Netherlands | |
Principal Investigator: | Hans JW de Wilt, MD, PhD | Radboud University Medical Centre, Nijmegen, the Netherlands |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT02271828 |
Other Study ID Numbers: |
BOOG 2013-08 BOOG 2013-08 ( Other Identifier: Dutch Breast Cancer Trialists' Group (BOOG) ) KWF UM 2014-6679 ( Other Grant/Funding Number: The Dutch Cancer Society (KWF) ) |
First Posted: | October 22, 2014 Key Record Dates |
Last Update Posted: | May 4, 2018 |
Last Verified: | May 2018 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |