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Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy

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ClinicalTrials.gov Identifier: NCT02271828
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Procedure: Sentinel lymph node procedure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1644 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.
Study Start Date : April 2015
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sentinel lymph node procedure
Sentinel lymph node procedure according to the Dutch breast cancer guideline
 Procedure: Sentinel lymph node procedure
Sentinel lymph node procedure according to the Dutch breast cancer guideline
No Intervention: No sentinel lymph node procedure
No sentinel lymph node procedure


Outcome Measures
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Primary Outcome Measures :
  1. Regional recurrence rate [ Time Frame: Up to ten years ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271828


Contacts
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Contact: Marjolein L Smidt, MD, PhD +31433877477

Locations
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Netherlands
Maastricht University Medical Centre+ Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Marjolein L Smidt, MD, PhD    +31433877477      
Principal Investigator: Marjolein L Smidt, MD, PhD         
Flevoziekenhuis Not yet recruiting
Almere, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Netherlands
Rijnstate Recruiting
Arnhem, Netherlands
Amphia ziekenhuis Not yet recruiting
Breda, Netherlands
Jeroen Bosch ziekenhuis Not yet recruiting
Den Bosch, Netherlands
Haga ziekenhuis Recruiting
Den Haag, Netherlands
Deventer ziekenhuis Recruiting
Deventer, Netherlands
Catharina ziekenhuis Not yet recruiting
Eindhoven, Netherlands
Maxima Medisch Centrum Recruiting
Eindhoven, Netherlands
Groene Hart ziekenhuis Not yet recruiting
Gouda, Netherlands
UMC Groningen Not yet recruiting
Groningen, Netherlands
Spaarne Gasthuis Not yet recruiting
Haarlem, Netherlands
Alrijne Not yet recruiting
Leiden, Netherlands
St. Antonius ziekenhuis Recruiting
Nieuwegein, Netherlands
Canisius-Wilhelmina ziekenhuis Not yet recruiting
Nijmegen, Netherlands
Radboud UMC Not yet recruiting
Nijmegen, Netherlands
Laurentius ziekenhuis Recruiting
Roermond, Netherlands
Diakonessenhuis Not yet recruiting
Utrecht, Netherlands
UMC Utrecht Not yet recruiting
Utrecht, Netherlands
Zuwehofpoort ziekenhuis Recruiting
Woerden, Netherlands
Isala Klinieken Recruiting
Zwolle, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University
Investigators
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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
More Information
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Additional Information:
Study description BOOG study center  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02271828     History of Changes
Other Study ID Numbers: BOOG 2013-08
BOOG 2013-08 ( Other Identifier: Dutch Breast Cancer Trialists' Group (BOOG) )
KWF UM 2014-6679 ( Other Grant/Funding Number: The Dutch Cancer Society (KWF) )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases