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

Breast Neoplasms Clinical Trial

Official title:

Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02271828
• Other study ID #: BOOG 2013-08
• Secondary ID: BOOG 2013-08KWF
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 2027

Study information

• Verified date: May 2018
• Source: Maastricht University Medical Center
• Contact: Marjolein L Smidt, MD, PhD
• Phone: +31433877477
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1644
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• Sentinel lymph node procedure
Sentinel lymph node procedure according to the Dutch breast cancer guideline

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	Rijnstate	Arnhem
Netherlands	Amphia ziekenhuis	Breda
Netherlands	Jeroen Bosch ziekenhuis	Den Bosch
Netherlands	Haga ziekenhuis	Den Haag
Netherlands	Deventer ziekenhuis	Deventer
Netherlands	Catharina ziekenhuis	Eindhoven
Netherlands	Maxima Medisch Centrum	Eindhoven
Netherlands	Groene Hart ziekenhuis	Gouda
Netherlands	UMC Groningen	Groningen
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	Alrijne	Leiden
Netherlands	Maastricht University Medical Centre+	Maastricht	Limburg
Netherlands	St. Antonius ziekenhuis	Nieuwegein
Netherlands	Canisius-Wilhelmina ziekenhuis	Nijmegen
Netherlands	Radboud UMC	Nijmegen
Netherlands	Laurentius ziekenhuis	Roermond
Netherlands	Diakonessenhuis	Utrecht
Netherlands	UMC Utrecht	Utrecht
Netherlands	Zuwehofpoort ziekenhuis	Woerden
Netherlands	Isala Klinieken	Zwolle

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Borstkanker Onderzoek Groep, Dutch Cancer Society, Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Study description BOOG study center