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

The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02112682

Enrollment

Registered

2014-04-14

Start date

2014-06-30

Completion date

2018-03-31

Last updated

2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Sentinel lymph node metastasis, Completion axillary lymph node dissection, Axillary radiotherapy

Brief summary

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.

Interventions

PROCEDURECompletion axillary treatment

Completion axillary treatment according to the Dutch breast cancer guideline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Regional recurrence rate	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).

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026