About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Breast Surgery (BCS or mastectomy) with TAD/SNB
- Adjuvant Radiation Therapy
Treatment groups
Sponsors and collaborators
Alice Chung
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution