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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Maastricht University Medical Center
Sponsor:
Collaborators:
Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT02112682
First received: April 10, 2014
Last updated: June 23, 2014
Last verified: June 2014

April 10, 2014
June 23, 2014
June 2014
June 2027   (final data collection date for primary outcome measure)
Regional recurrence rate [ Time Frame: up to ten years ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT02112682 on ClinicalTrials.gov Archive Site
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Not Provided
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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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
Procedure: Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
  • Active Comparator: Completion axillary treatment
    Completion axillary treatment according to the Dutch breast cancer guideline
    Intervention: Procedure: Completion axillary treatment
  • No Intervention: No completion axillary treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
878
Not Provided
June 2027   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Marjolein L Smidt, MD, PhD +31433877477
Netherlands
 
NCT02112682
BOOG 2013-07, KWF UM 2013-5920
Yes
Maastricht University Medical Center
Maastricht University Medical Center
  • Borstkanker Onderzoek Groep
  • Dutch Cancer Society
  • Maastricht University
Principal Investigator: Marjolein L Smidt, MD, PhD Maastricht University Medical Centre+, Maastricht, the Netherlands
Principal Investigator: Hans JW de Wilt, MD, PhD Radboud University Medical Centre, Nijmegen, the Netherlands
Maastricht University Medical Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP