Clinical trial NCT02271828: Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
Official title: Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Borstkanker Onderzoek Groep
name: Dutch Cancer Society
name: Maastricht University
First posted: 2014-10-22
Enrollment: 1644
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 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.


Eligibility criteria: 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

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: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch ziekenhuis
city: Den Haag
country: Netherlands
facility: Haga ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Gouda
country: Netherlands
facility: Groene Hart ziekenhuis
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Leiden
country: Netherlands
facility: Alrijne
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Roermond
country: Netherlands
facility: Laurentius ziekenhuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Woerden
country: Netherlands
facility: Zuwehofpoort ziekenhuis
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, Vane MLG, van Dalen T, van der Hage JA, Strobbe LJA, Boersma LJ, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, Van de Vijver KKBT, de Vries J, Westenberg AH, Kessels AGH, de Wilt JHW, Smidt ML. Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08). BMC Cancer. 2017 Jul 1;17(1):459. doi: 10.1186/s12885-017-3443-x.