TAD After Chemotherapy in Locally Advanced Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Locally advanced breast cancer tumours (cN2 or T4) after Neoadjuvant chemotherapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Target Axillary Dissection
Procedure/SurgeryTAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
TAD validation in locally advanced breast cancer
False negative rate when performing TAD after NAC
Time frame
3 yearsSecondary outcomes
1
Ultrasound validity to evaluate axillary response after NAC
False-negative and positive rates of axillary ultrasound after NAC to assess lymph node response
Time frame
3 years2
MRI validity to evaluate axillary response after NAC
False-negative and positive rates of axillary MRI after NAC to asses lymph node response
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov