To propose a regional staging protocol, lymphatic mapping and sentinel node biopsy, for patients with locally recurrent breast cancer in the absence of guidelines for regional staging procedures and to registrate data derived from this study.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Registration of technical feasibility and validity of lymphatic mapping and
sentinel node biopsy in patients with locally recurrent breast cancer as well
as registration of lymphatic drainage pathways and sentinel lymph node status.
Furthermore, the influence of this staging procedure on therapeutic decisions
will be evaluated.
Secondary outcome
Not applicable
Background summary
Like in primary breast cancer, prognosis in recurrent breast cancer is
correlated with regional lymph node status. Therefore, it seems sensible to
perform lymphatic staging in case of an intact axillary lymph node basin,
although this has not been described in guidelines yet. Due to surgery and
radiotherapy lymph drainage pathways could be altered. These aberrant drainage
pathways could be detected with lymphatic mapping and sentinel node biopsy
leading to a more thorough staging and possible change in treatment strategy.
Study objective
To propose a regional staging protocol, lymphatic mapping and sentinel node
biopsy, for patients with locally recurrent breast cancer in the absence of
guidelines for regional staging procedures and to registrate data derived from
this study.
Study design
A prospective, multicenter, national registration study.
Study burden and risks
When performing lymphatic mapping and SNB, patients could be spared a
significant amount of additional morbidity in case of a negative sentinel node.
Furthermore, lymphatic drainage could have been altered due to former surgery
and/or radiotherapy. These aberrant drainage pathways can be detected with
lymphatic mapping and SNB leading to a more thorough staging. In this study,
patients undergo an additional sentinel node procedure next to surgery and, if
necessary, ipsilateral axillary lymph node dissection. Risks involve the very
small possibility of anaphylaxis to *99mTc-colloidal albumin* or blue dye
injection fluids. Radiation exposure due to lymphatic mapping is negligible.
Postbus 1350
5602 ZA Eindhoven
NL
Postbus 1350
5602 ZA Eindhoven
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19199.060.07 |