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 |
 Funding by KWF |
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| 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):
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