Studieoverzicht - 2009-02 SNARB

 
Number 2009-02 SNARB
Nickname SNARB
Status Closed Date: 01-04-2012
Inclusion closed
Other study number(s) M07-1792 / NL 19199.060.07
Participating parties/groups
Full title Sentinel Node And Recurrent Breast cancer; Regional staging proposal and registration
Phase and type Observational
Age ≥ 18
Menopausal status Not applicable
Indication Locoregional
Subindication Not applicable
Target sample size 300
Actual accrual 220 Date: 01-11-2011
Estimated study completion date 31-12-2012
CCMO approval Yes Date: Nr: NL 19199.060.07
EudraCT nr.
Trial Register
METC approval Yes Date: 28-01-2008 METC: Catharina Ziekenhuis Nr: M07-1792
Amendments Date:
KWF-CKS approval Yes Date: 09-11-2010 Nr: 2009-4466
News item
Website http://www.boogstudycenter.nl
Sponsor Catharina Ziekenhuis Eindhoven
Principal Investigator(s) G.A.P. Nieuwenhuijzen; R. Roumen
Study manager A.J.G. Maaskant
Central datamanagement and randomization A.J.G. Maaskant; Catharina Ziekenhuis Eindhoven
Monitoring n.a.
Local datamanagement
Funding Logo KWF.jpgFunding by KWF
Extra

Design:

Prospective, multicenter, national registration study

Women above 18 years old with locally recurrent breast cancer after earlier BCT or modified radical mastectomy. Four groups can be distinguished:

  • Local recurrence after BCT and negative SNB (intact axillary lymph node basin)
  • Local recurrence after BCT and ALND or axillary radiotherapy (incl. after positive SNB)
  • Local recurrence after modified radical mastectomy
  • Local recurrence after previous DCIS
Objectives:

 

Primary objective: To propose and evaluate a new regional staging modality for patients with locally recurrent breast cancer in absence of guidelines for regional staging procedures.

Secondary objectives:

  • To determine technical feasibility of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer.
  • To determine validity of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer after previous SNB and negative sentinel node.
  • To determine lymphatic drainage pathways in patients with locally recurrent breast cancer.
  • To determine lymph node status through SNB in patients with locally recurrent breast cancer.
  • To evaluate the clinical consequences of identifying the lymphatic drainage and its subsequent sentinel node biopsy in locally recurrent breast cancer.
Endpoints:

 

  • Registration of technical feasibility of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer.
  • Registration of success rate of lymphatic mapping and SNB in patients with locally recurrent breast cancer.
  • Registration of validity of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer.
  • Registration of lymphatic drainage pathways in patients with locally recurrent breast cancer.
  • Registration of sentinel lymph node status in patients with locally recurrent breast cancer.
  • Registration of possible influence of lymphatic mapping and SNB on therapeutic decisions in patients with locally recurrent breast cancer.
Main eligibility criteria:

 

Inclusion criteria

  • Operable cytological /histological confirmed locally recurrent breast cancer
  • Having obtained an informed consent

  

Exclusion criteria

  • Proven ipsi- or contralateral regional lymph node metastases (ultrasound and FNA)
  • Known to be allergic to "99mTc-colloidal albumin" or blue dye injection fluids.
Documents (public):

Protocol synopsis

Documents (protected):
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