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

Primary Purpose

Breast Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Completion axillary treatment
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 focused on measuring Sentinel lymph node metastasis, Completion axillary lymph node dissection, Axillary radiotherapy

Eligibility Criteria

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

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

Sites / Locations

  • Maastricht University Medical Centre+
  • Flevoziekenhuis
  • Meander Medisch Centrum
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Gelre Ziekenhuizen
  • Rijnstate
  • Amphia ziekenhuis
  • Reinier de Graaf
  • Jeroen Bosch ziekenhuis
  • Bronovo / Medisch Centrum Haaglanden
  • Haga Ziekenhuis
  • Deventer Ziekenhuis
  • Catharina Ziekenhuis Eindhoven
  • Medisch Spectrum Twente
  • Groene Hart Ziekenhuis
  • Martini Ziekenhuis
  • UMC Groningen
  • Zuyderland Medisch Centrum
  • Tergooi
  • Alrijne ziekenhuis
  • St. Antonius Ziekenhuis
  • Canisius-Wilhelmina Ziekenhuis
  • Radboud university medical center
  • Laurentius Ziekenhuis
  • Zuyderland Medisch Centrum
  • Antonius Ziekenhuis
  • Rivierenland
  • St. Elisabeth Ziekenhuis
  • Diakonessenhuis Utrecht
  • Maxima Medisch Centrum
  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Completion axillary treatment

No completion axillary treatment

Arm Description

Completion axillary treatment according to the Dutch breast cancer guideline

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
April 10, 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
NCT02112682
Brief Title
Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
Official Title
The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
slow accrual rate
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Sentinel lymph node metastasis, Completion axillary lymph node dissection, Axillary radiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Completion axillary treatment
Arm Type
Active Comparator
Arm Description
Completion axillary treatment according to the Dutch breast cancer guideline
Arm Title
No completion axillary treatment
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Completion axillary treatment
Intervention Description
Completion axillary treatment 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 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
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
Facility Name
Flevoziekenhuis
City
Almere
Country
Netherlands
Facility Name
Meander Medisch Centrum
City
Amersfoort
Country
Netherlands
Facility Name
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
Country
Netherlands
Facility Name
Gelre Ziekenhuizen
City
Apeldoorn
Country
Netherlands
Facility Name
Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Amphia ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Reinier de Graaf
City
Delft
Country
Netherlands
Facility Name
Jeroen Bosch ziekenhuis
City
Den Bosch
Country
Netherlands
Facility Name
Bronovo / Medisch Centrum Haaglanden
City
Den Haag
Country
Netherlands
Facility Name
Haga Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
Country
Netherlands
Facility Name
Tergooi
City
Hilversum
Country
Netherlands
Facility Name
Alrijne ziekenhuis
City
Leiden
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
Country
Netherlands
Facility Name
Radboud university medical center
City
Nijmegen
Country
Netherlands
Facility Name
Laurentius Ziekenhuis
City
Roermond
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Sittard
Country
Netherlands
Facility Name
Antonius Ziekenhuis
City
Sneek
Country
Netherlands
Facility Name
Rivierenland
City
Tiel
Country
Netherlands
Facility Name
St. Elisabeth Ziekenhuis
City
Tilburg
Country
Netherlands
Facility Name
Diakonessenhuis Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26335105
Citation
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.
Results Reference
derived

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

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