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

Phase 2

Recruiting

• Conditions: Female Breast Cancer; Mastectomy; Lymphedema; Breast Cancer; Axillary Nodal Disease; Axilla; Breast; Tumor, Breast
• Interventions: Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB; Radiation: Adjuvant Radiation Therapy

• Registration Number: NCT06092892
• Lead Sponsor: Alice Chung

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Study Start: 2024-04-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2031-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Breast Surgery (BCS or mastectomy) with TAD/SNB	-
Single Arm	Adjuvant Radiation Therapy	-

Primary Outcome Measures

Name	Time	Method
Regional recurrence rate	5 Years	Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.

Secondary Outcome Measures

Name	Time	Method
Local recurrence rate	5 Years	Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.
Disease-free survival (DFS)	5 Years	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.
Breast cancer specific survival (BCSS) rate	5 Years	Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period
Overall survival (OS)	5 Years	Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.

Trial Locations

Locations (3)

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute; 🇺🇸 Los Angeles, California, United States

CS Cancer at Huntington Cancer Center; 🇺🇸 Pasadena, California, United States

CS Cancer at Valley Oncology Medical Group; 🇺🇸 Tarzana, California, United States