IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases

Study Overview
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Brief Summary
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The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.

Official Title
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IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases

Conditions
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Breast Cancer, Axillary Nodal Disease, Female Breast Cancer, Axilla; Breast, Mastectomy; Lymphedema, Tumor, Breast

Intervention / Treatment
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* Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB
* Radiation: Adjuvant Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age ≥ 45 Clinical T1-2N0 ER+ invasive breast cancer US detected biopsy proven axillary nodal disease Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Palpable nodes on physical exam Her2+ or ER- invasive breast cancer Extranodal extension > 3 mm on nodal biopsy More than 2 suspicious nodes on preoperative imaging

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB<br>* Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy<br>Radiation: Adjuvant Radiation Therapy<br>* Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional recurrence rate | Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period. | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence rate | Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period. | 5 Years | 
| Disease-free survival (DFS) | Disease-free survival (DFS) is defined as the length of time after targeted axillary dissection (TAD) that the subject survives without any signs or symptoms of breast cancer. | 5 Years | 
| Breast cancer specific survival (BCSS) rate | Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period | 5 Years | 
| Overall survival (OS) | Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive. | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T1-2N0 ER+ invasive, biopsy, upfront lumpectomy