IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients with Breast Cancer with Nodal Metastases

Sponsor: Alice Chung

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06092892

Patient View

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

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

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