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.
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.
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
Single group
Breast Surgery (BCS or mastectomy) with TAD/SNB
Procedure/SurgeryBreast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
Adjuvant Radiation Therapy
RadiationBreast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
Regional recurrence rate
Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.
Local recurrence rate
Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.
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.
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
Overall survival (OS)
Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.
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Alice Chung
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
