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Trial Title:
TAD After Chemotherapy in Locally Advanced Breast Cancer
NCT ID:
NCT05763641
Condition:
Sentinel Lymph Node
Breast Cancer
Locally Advanced
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Target Axillary Dissection
Description:
TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection
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.
Criteria for eligibility:
Study pop:
Locally advanced breast cancer tumours (cN2 or T4) after Neoadjuvant chemotherapy
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital de Bellvitge
Address:
City:
Hospitalet de Llobregat
Zip:
08907
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Amparo Garcia-Tejedor, MDPhD
Phone:
0034-660223417
Email:
agarciat@bellvitgehospital.cat
Facility:
Name:
Hospital Clínico y Provincial de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Isaac Cebrecos, MD
Email:
CEBRECOS@clinic.cat
Start date:
February 1, 2021
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Hospital Universitari de Bellvitge
Agency class:
Other
Source:
Hospital Universitari de Bellvitge
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05763641
