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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
RECRUITINGCS Cancer at Huntington Cancer Center
Pasadena, California, United States
RECRUITINGCS Cancer at Valley Oncology Medical Group
Tarzana, California, United States
RECRUITINGRegional recurrence rate
Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.
Time frame: 5 Years
Local recurrence rate
Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.
Time frame: 5 Years
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.
Time frame: 5 Years
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
Time frame: 5 Years
Overall survival (OS)
Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.
Time frame: 5 Years
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