IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
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 studied
Breast Cancer, Axillary Nodal Disease, Female Breast Cancer, Axilla; Breast, Mastectomy; Lymphedema, Tumor, Breast
About this study
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.
Interventions
- 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
Primary outcomes
- Regional recurrence rate (5 Years)
Eligibility information
Study locations
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California 90048 United States
- CS Cancer at Huntington Cancer Center, Pasadena, California 91105 United States
- CS Cancer at Valley Oncology Medical Group, Tarzana, California 91356 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.