IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients with Breast Cancer with Nodal Metastases
Sponsor: Alice Chung
ClinicalTrials ID:NCT06092892
This phase II trial evaluates recurrence and survival in women aged ≥45 with T1-2N0 ER+ breast cancer and biopsy-confirmed nodal disease. Participants undergo breast surgery (BCS or mastectomy) with TAD/SNB, followed by adjuvant radiation therapy. Eligibility requires informed consent and compliance with study protocols.
Patient Parameters
| Parameter | Options |
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Program Overview
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | 90048 | Los Angeles | California |
| CS Cancer at Huntington Cancer Center | 91105 | Pasadena | California |
| CS Cancer at Valley Oncology Medical Group | 91356 | Tarzana | California |
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