TAD After Chemotherapy in Locally Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763641
• Other study ID #: PR351/20
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Locally Advanced
• Sentinel Lymph Node

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