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

Breast Neoplasms Clinical Trial

Official title:

The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02112682
• Other study ID #: BOOG 2013-07
• Secondary ID: KWF UM 2013-5920
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	Gelre Ziekenhuizen	Apeldoorn
Netherlands	Rijnstate	Arnhem
Netherlands	Amphia ziekenhuis	Breda
Netherlands	Reinier de Graaf	Delft
Netherlands	Jeroen Bosch ziekenhuis	Den Bosch
Netherlands	Bronovo / Medisch Centrum Haaglanden	Den Haag
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	UMC Groningen	Groningen
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	Tergooi	Hilversum
Netherlands	Alrijne ziekenhuis	Leiden
Netherlands	Maastricht University Medical Centre+	Maastricht	Limburg
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Radboud university medical center	Nijmegen
Netherlands	Laurentius Ziekenhuis	Roermond
Netherlands	Zuyderland Medisch Centrum	Sittard
Netherlands	Antonius Ziekenhuis	Sneek
Netherlands	Rivierenland	Tiel
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Netherlands	Diakonessenhuis Utrecht	Utrecht
Netherlands	Maxima Medisch Centrum	Veldhoven
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