IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
Alice Chung
45 participants
Apr 7, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria4
- 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
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06092892