NCT06092892

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Alice Chung · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Breast Surgery (BCS or mastectomy) with TAD/SNB	Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
RADIATION	Adjuvant Radiation Therapy	Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy

Timeline

• Start date: 2024-04-07
• Primary completion: 2031-04-01
• Completion: 2031-04-01
• First posted: 2023-10-23
• Last updated: 2025-12-10

Locations

3 sites across 1 country: United States