TAD After Chemotherapy in Locally Advanced Breast Cancer | NCT05763641

Studies
TAD After Chemotherapy in Locally Advanced Breast Cancer

NCT05763641

Sponsor

Hospital Universitari de Bellvitge

Status

Recruiting

Last Update Posted

Sep 10, 2025Actual

Enrollment

162Estimated

Phase

Not provided

Conditions

Sentinel Lymph Node
Breast Cancer
Locally Advanced

Interventions

Target Axillary Dissection

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Feb 28, 2023

First Submission Date that Met QC Criteria

Feb 28, 2023

First Posted Date

Mar 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2025

Last Update Posted Date

Sep 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amparo Garcia-Tejedor, Clinical Professor, Hospital Universitari de BellvitgePrincipal Investigator

Lead Sponsor

Hospital Universitari de BellvitgeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

162Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Target Axillary Dissection	Procedure	TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TAD validation in locally advanced breast cancer	False negative rate when performing TAD after NAC	3 years

Secondary Outcomes

Measure	Description	Time Frame
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
MRI validity to evaluate axillary response after NAC

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Locally advanced breast cancer tumours (cN2 or T4) after Neoadjuvant chemotherapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amparo García-Tejedor, MDPhD	Contact	0034-932607702	2812	agarciat@bellvitgehospital.cat

Overall Officials

Name	Affiliation	Role
amparo Garcia-Tejedor, MDPhD	Instituto de Investigación Biomédica de Bellvitge (IDIBELL)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Bellvitge	Recruiting	L'Hospitalet de Llobregat	Barcelona	08907	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

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Browse Branches

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