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