TAD After Chemotherapy in Locally Advanced Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2026-06-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sentinel Lymph Node Breast Cancer Locally Advanced

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Target Axillary Dissection

TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No