NCT06092892PHASE2Recruiting
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Alice Chung
Start Date
4/7/2024
Completion Date
4/1/2031
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 Criteria
Age Range: 45 years to No maximum
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
PROCEDURE
Breast Surgery (BCS or mastectomy) with TAD/SNB
RADIATION
Adjuvant Radiation Therapy
Conditions
Breast CancerAxillary Nodal DiseaseFemale Breast CancerAxilla; BreastMastectomy; LymphedemaTumor, Breast
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