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Recruiting
NCT06092892
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Conditions: Breast Cancer, Axillary Nodal Disease, Female Breast Cancer, Axilla; Breast, Mastectomy; Lymphedema, Tumor, Breast
Sex: Female
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 45
Sponsor: Alice Chung
Location: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Los Angeles California
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
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
Source: ClinicalTrials.gov (NCT06092892). StuddyBuddy aggregates publicly available trial information.
