IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
Alice Chung
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.
Eligibility
- Age range
- 45+ years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- ProcedureBreast Surgery (BCS or mastectomy) with TAD/SNB
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
- RadiationAdjuvant Radiation Therapy
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
Locations (3)
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California
- CS Cancer at Huntington Cancer CenterPasadena, California
- CS Cancer at Valley Oncology Medical GroupTarzana, California