Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy

Maastricht University Medical Centre (MUMC)

Status

Terminated

Conditions

Breast Neoplasms

Treatments

Procedure: Completion axillary treatment

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02112682

BOOG 2013-07

KWF UM 2013-5920 (Other Grant/Funding Number)

Details and patient eligibility

About

STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.

PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.

HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.

Enrollment

52 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female
Aged 18 years or older
Pathologically confirmed invasive unilateral breast carcinoma
A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
Will be or is treated with mastectomy
Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
Sentinel lymph node procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
Written informed consent

Exclusion criteria

Clinically node positive pre-operative
Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
Solitary parasternal sentinel lymph node metastasis (pN1b)
Bilateral breast cancer
Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
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