Clinical trial NCT02112682: Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
Official title: The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Sentinel lymph node metastasis
Completion axillary lymph node dissection
Axillary radiotherapy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Borstkanker Onderzoek Groep
name: Dutch Cancer Society
name: Maastricht University
First posted: 2014-04-14
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Regional recurrence rate
timeFrame: up to ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre+
state: Limburg
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch ziekenhuis
city: Den Haag
country: Netherlands
facility: Bronovo / Medisch Centrum Haaglanden
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Hilversum
country: Netherlands
facility: Tergooi
city: Leiden
country: Netherlands
facility: Alrijne ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
city: Roermond
country: Netherlands
facility: Laurentius Ziekenhuis
city: Sittard
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Tiel
country: Netherlands
facility: Rivierenland
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Maastricht University Medical Centre+, Maastricht, the Netherlands
name: Marjolein L Smidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Centre, Nijmegen, the Netherlands
name: Hans JW de Wilt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Roozendaal LM, de Wilt JH, van Dalen T, van der Hage JA, Strobbe LJ, Boersma LJ, Linn SC, Lobbes MB, Poortmans PM, Tjan-Heijnen VC, Van de Vijver KK, de Vries J, Westenberg AH, Kessels AG, Smidt ML. The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch randomized controlled multicentre trial (BOOG 2013-07). BMC Cancer. 2015 Sep 3;15:610. doi: 10.1186/s12885-015-1613-2.