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

Primary Purpose

Breast Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Sentinel lymph node procedure
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Centre+Recruiting
  • Flevoziekenhuis
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek HospitalRecruiting
  • RijnstateRecruiting
  • Amphia ziekenhuis
  • Jeroen Bosch ziekenhuis
  • Haga ziekenhuisRecruiting
  • Deventer ziekenhuisRecruiting
  • Catharina ziekenhuis
  • Maxima Medisch CentrumRecruiting
  • Groene Hart ziekenhuis
  • UMC Groningen
  • Spaarne Gasthuis
  • Alrijne
  • St. Antonius ziekenhuisRecruiting
  • Canisius-Wilhelmina ziekenhuis
  • Radboud UMC
  • Laurentius ziekenhuisRecruiting
  • Diakonessenhuis
  • UMC Utrecht
  • Zuwehofpoort ziekenhuisRecruiting
  • Isala KliniekenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sentinel lymph node procedure

No sentinel lymph node procedure

Arm Description

Sentinel lymph node procedure according to the Dutch breast cancer guideline

No sentinel lymph node procedure

Outcomes

Primary Outcome Measures

Regional recurrence rate
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).

Secondary Outcome Measures

Full Information

First Posted
October 20, 2014
Last Updated
May 3, 2018
Sponsor
Maastricht University Medical Center
Collaborators
Borstkanker Onderzoek Groep, Dutch Cancer Society, Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT02271828
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Borstkanker Onderzoek Groep, Dutch Cancer Society, Maastricht University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1644 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentinel lymph node procedure
Arm Type
Active Comparator
Arm Description
Sentinel lymph node procedure according to the Dutch breast cancer guideline
Arm Title
No sentinel lymph node procedure
Arm Type
No Intervention
Arm Description
No sentinel lymph node procedure
Intervention Type
Procedure
Intervention Name(s)
Sentinel lymph node procedure
Intervention Description
Sentinel lymph node procedure according to the Dutch breast cancer guideline
Primary Outcome Measure Information:
Title
Regional recurrence rate
Description
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).
Time Frame
Up to ten years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marjolein L Smidt, MD, PhD
Phone
+31433877477
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjolein L Smidt, MD, PhD
Organizational Affiliation
Maastricht University Medical Centre, Maastricht, the Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans JW de Wilt, MD, PhD
Organizational Affiliation
Radboud University Medical Centre, Nijmegen, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjolein L Smidt, MD, PhD
Phone
+31433877477
First Name & Middle Initial & Last Name & Degree
Marjolein L Smidt, MD, PhD
Facility Name
Flevoziekenhuis
City
Almere
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Rijnstate
City
Arnhem
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Amphia ziekenhuis
City
Breda
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Jeroen Bosch ziekenhuis
City
Den Bosch
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Haga ziekenhuis
City
Den Haag
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Deventer ziekenhuis
City
Deventer
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Catharina ziekenhuis
City
Eindhoven
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Maxima Medisch Centrum
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Groene Hart ziekenhuis
City
Gouda
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Spaarne Gasthuis
City
Haarlem
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Alrijne
City
Leiden
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
St. Antonius ziekenhuis
City
Nieuwegein
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Canisius-Wilhelmina ziekenhuis
City
Nijmegen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Radboud UMC
City
Nijmegen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Laurentius ziekenhuis
City
Roermond
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Diakonessenhuis
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Zuwehofpoort ziekenhuis
City
Woerden
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
28668073
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.
Results Reference
derived
Links:
URL
https://www.boogstudycenter.nl/studie/273/2013-08-lumpectomie.html
Description
Study description BOOG study center

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

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