Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
NCT ID: NCT02112682
Last Updated: 2018-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
52 participants
INTERVENTIONAL
2014-06-30
2018-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
No completion axillary treatment
No interventions assigned to this group
Interventions
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Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Borstkanker Onderzoek Groep
NETWORK
Dutch Cancer Society
OTHER
Maastricht University
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marjolein L Smidt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre+, Maastricht, the Netherlands
Hans JW de Wilt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Centre, Nijmegen, the Netherlands
Locations
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Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands
Jeroen Bosch ziekenhuis
's-Hertogenbosch, , Netherlands
Flevoziekenhuis
Almere Stad, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Gelre Ziekenhuizen
Apeldoorn, , Netherlands
Rijnstate
Arnhem, , Netherlands
Amphia ziekenhuis
Breda, , Netherlands
Reinier de Graaf
Delft, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
UMC Groningen
Groningen, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Tergooi
Hilversum, , Netherlands
Alrijne ziekenhuis
Leiden, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Radboud university medical center
Nijmegen, , Netherlands
Laurentius Ziekenhuis
Roermond, , Netherlands
Zuyderland Medisch Centrum
Sittard, , Netherlands
Antonius Ziekenhuis
Sneek, , Netherlands
Bronovo / Medisch Centrum Haaglanden
The Hague, , Netherlands
Haga Ziekenhuis
The Hague, , Netherlands
Rivierenland
Tiel, , Netherlands
St. Elisabeth Ziekenhuis
Tilburg, , Netherlands
Diakonessenhuis Utrecht
Utrecht, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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References
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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.
Other Identifiers
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KWF UM 2013-5920
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BOOG 2013-07
Identifier Type: -
Identifier Source: org_study_id
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