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TAD After Chemotherapy in Locally Advanced Breast Cancer

Sponsor
Hospital Universitari de Bellvitge (Other)
Overall Status
Recruiting
CT.gov ID
NCT05763641
Collaborator
(none)
162
Enrollment
2
Locations
36
Anticipated Duration (Months)
81
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Target Axillary Dissection

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
162 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Outcome Measures

Primary Outcome Measures

  1. TAD validation in locally advanced breast cancer [3 years]

    False negative rate when performing TAD after NAC

Secondary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
2 Hospital Clínico y Provincial de Barcelona Barcelona Spain 08036

Sponsors and Collaborators

  • Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: amparo Garcia-Tejedor, MDPhD, Instituto de Investigación Biomédica de Bellvitge (IDIBELL)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amparo Garcia-Tejedor, Clinical Professor, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT05763641
Other Study ID Numbers:
  • PR351/20
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Mar 14, 2023