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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05763641
Other study ID # PR351/20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date February 1, 2024

Study information

Verified date March 2023
Source Hospital Universitari de Bellvitge
Contact Amparo García-Tejedor, MDPhD
Phone 0034-932607702
Email agarciat@bellvitgehospital.cat
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 162
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Target Axillary Dissection
TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection

Locations

Country Name City State
Spain Hospital Clínico y Provincial de Barcelona Barcelona
Spain Hospital de Bellvitge Hospitalet de Llobregat Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary TAD validation in locally advanced breast cancer False negative rate when performing TAD after NAC 3 years
Secondary Ultrasound validity to evaluate axillary response after NAC False-negative and positive rates of axillary ultrasound after NAC to assess lymph node response 3 years
Secondary MRI validity to evaluate axillary response after NAC False-negative and positive rates of axillary MRI after NAC to asses lymph node response 3 years
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