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

Maastricht University Medical Centre (MUMC)

Status

Active, not recruiting

Conditions

Breast Neoplasms

Treatments

Procedure: Sentinel lymph node procedure

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02271828

KWF UM 2014-6679 (Other Grant/Funding Number)

BOOG 2013-08 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

1,644 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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