Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre+, Maastricht, Limburg, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel lymph node procedure

Procedure

Sentinel lymph node procedure according to the Dutch breast cancer guideline

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University

Registry information

Official study title

Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.

Important dates

Study start: 2015
Primary completion: 2027
Study completion: 2027
First posted: Oct 22, 2014
Registry last updated: May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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