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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 Breast Cancer With Nodal Metastases

Recruiting
45 years and older
Female
Phase 2

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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

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

Study details
    Breast Cancer
    Axillary Nodal Disease
    Female Breast Cancer
    Axilla; Breast
    Mastectomy; Lymphedema
    Tumor
    Breast

NCT06092892

Alice Chung

19 August 2025

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