Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Sentinel lymph node metastasis, Completion axillary lymph node dissection, Axillary radiotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Completion axillary treatment
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Locations
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands
Status: Recruiting
Contact: Marjolein L Smidt, MD, PhD - +31433877477
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Status: Not yet recruiting
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Status: Recruiting
Bronovo
Den Haag, Netherlands
Status: Not yet recruiting
Haga Ziekenhuis
Den Haag, Netherlands
Status: Not yet recruiting
Deventer Ziekenhuis
Deventer, Netherlands
Status: Recruiting
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
Status: Not yet recruiting
Medisch Spectrum Twente
Enschede, Netherlands
Status: Not yet recruiting
Groene Hart Ziekenhuis
Gouda, Netherlands
Status: Not yet recruiting
Martini Ziekenhuis
Groningen, Netherlands
Status: Not yet recruiting
Atrium Medisch Centrum
Heerlen, Netherlands
Status: Recruiting
Tergooi
Hilversum, Netherlands
Status: Not yet recruiting
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Status: Not yet recruiting
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Status: Not yet recruiting
Radboud university medical center
Nijmegen, Netherlands
Status: Not yet recruiting
Laurentius Ziekenhuis
Roermond, Netherlands
Status: Recruiting
Orbis Medisch Centrum
Sittard, Netherlands
Status: Recruiting
Antonius Ziekenhuis
Sneek, Netherlands
Status: Recruiting
Rivierenland
Tiel, Netherlands
Status: Recruiting
St. Elisabeth Ziekenhuis
Tilburg, Netherlands
Status: Not yet recruiting
Diakonessenhuis Utrecht
Utrecht, Netherlands
Status: Not yet recruiting
Maxima Medisch Centrum
Veldhoven, Netherlands
Status: Not yet recruiting
Isala Klinieken
Zwolle, Netherlands
Status: Recruiting
Start Date
June 2014
Sponsors
Maastricht University Medical Center
Source
Maastricht University Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page