Breast Cancer, Locally Advanced, Sentinel Lymph Node
Conditions
Brief summary
This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).
Detailed description
The procedure will consist of marking the pathological lymph node with 1 clip before the start of neoadjuvant chemotherapy (NAC) and performing surgery after completing the NAC. The TAD will include the exeresis of the node marked with a clip, and of the sentinels marked with technetium and/or patent blue, seeking to obtain at least 3 lymph nodes. Subsequently, the axillary lymphadenectomy will be completed to identify the false negative rate. An initial analysis will be carried out with the first 30 cases, and if there are more than 2 false negative cases, it will be completed until 81 cases of TAD without associated disease are obtained.
Interventions
PROCEDURETarget Axillary Dissection
TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection
Sponsors
Hospital Universitari de Bellvitge
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Axillary lymph node metastasis proven by cytology * Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis) * Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria * Neoadjuvant chemotherapy
Exclusion criteria
* cN3 verified by imaging tests * N2 due to internal mammary involvement (N2b). * Tumors whose surrogate molecular subtype is luminal A. * Patients undergoing neoadjuvant endocrine therapy * Patients with local recurrences and metastatic tumors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TAD validation in locally advanced breast cancer | 3 years | False negative rate when performing TAD after NAC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound validity to evaluate axillary response after NAC | 3 years | False-negative and positive rates of axillary ultrasound after NAC to assess lymph node response |
| MRI validity to evaluate axillary response after NAC | 3 years | False-negative and positive rates of axillary MRI after NAC to asses lymph node response |
Countries
Spain
Contacts
CONTACTAmparo García-Tejedor, MDPhD
PRINCIPAL_INVESTIGATORamparo Garcia-Tejedor, MDPhD
Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
Outcome results
None listed