NCT02112682

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

31 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

3.8 years

First QC Date

April 10, 2014

Last Update Submit

May 3, 2018

Conditions

Breast Neoplasms

Keywords

Sentinel lymph node metastasisCompletion axillary lymph node dissectionAxillary radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    up to ten years

Study Arms (2)

Completion axillary treatment

ACTIVE COMPARATOR

Completion axillary treatment according to the Dutch breast cancer guideline

Procedure: Completion axillary treatment

No completion axillary treatment

NO INTERVENTION

Interventions

Completion axillary treatmentPROCEDURE

Completion axillary treatment according to the Dutch breast cancer guideline

Completion axillary treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Maastricht University Medical Centre+

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Jeroen Bosch ziekenhuis

's-Hertogenbosch, Netherlands

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Meander Medisch Centrum

Amersfoort, Netherlands

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Location

Gelre Ziekenhuizen

Apeldoorn, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Amphia ziekenhuis

Breda, Netherlands

Location

Reinier de Graaf

Delft, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, Netherlands

Location

Tergooi

Hilversum, Netherlands

Location

Alrijne ziekenhuis

Leiden, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Radboud university medical center

Nijmegen, Netherlands

Location

Laurentius Ziekenhuis

Roermond, Netherlands

Location

Zuyderland Medisch Centrum

Sittard, Netherlands

Location

Antonius Ziekenhuis

Sneek, Netherlands

Location

Bronovo / Medisch Centrum Haaglanden

The Hague, Netherlands

Location

Haga Ziekenhuis

The Hague, Netherlands

Location

Rivierenland

Tiel, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Location

Diakonessenhuis Utrecht

Utrecht, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 26335105DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

NL(31)