SNARB

BOOG 2009-02

General Information

BOOG number

BOOG 2009-02

Nickname

SNARB

Status

Date: 01/04/2012

Other study number

M07-1792 / NL 19199.060.07

Full title

Sentinel Node And Recurrent Breast cancer; Regional staging proposal and registration

Indication

Subindication

Not applicable

Target sample size

300

Actual accrual

220
Date: 01/11/2011

Estimated study completion date

31/12/2012

Contact

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.

Funding

Funding by KWF

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.

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.

Regulatory Information

CCMO approval

Yes
Nr: NL 19199.060.07

EC approval

Yes
Date: 28/01/2008
Nr:1792-01-01

EC

Catharina Ziekenhuis

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