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

NCT02112682 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-05-09

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

PROCEDURE

Completion axillary treatment

Completion axillary treatment according to the Dutch breast cancer guideline

Sponsors & Collaborators

  • Borstkanker Onderzoek Groep

    collaborator NETWORK

  • Dutch Cancer Society

    collaborator OTHER

  • Maastricht University

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Marjolein L Smidt, MD, PhD · Maastricht University Medical Centre+, Maastricht, the Netherlands

  • Hans JW de Wilt, MD, PhD · Radboud University Medical Centre, Nijmegen, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112682 on ClinicalTrials.gov