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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Maastricht University Medical Center
Sponsor:
Collaborators:
Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT02112682
First received: April 10, 2014
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Procedure: Completion axillary treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Regional recurrence rate [ Time Frame: up to ten years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 878
Study Start Date: June 2014
Estimated Primary Completion Date: June 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
Procedure: Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
No Intervention: No completion axillary treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112682

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

Locations
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         
Sponsors and Collaborators
Maastricht University Medical Center
Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University
Investigators
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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02112682     History of Changes
Other Study ID Numbers: BOOG 2013-07, KWF UM 2013-5920
Study First Received: April 10, 2014
Last Updated: June 23, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Sentinel lymph node metastasis
Completion axillary lymph node dissection
Axillary radiotherapy

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

ClinicalTrials.gov processed this record on September 14, 2014