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

Last updated: August 5, 2025
Sponsor: Alice Chung
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Lymphedema

Cancer

Treatment

Adjuvant Radiation Therapy

Breast Surgery (BCS or mastectomy) with TAD/SNB

Breast Surgery (BCS or mastectomy) with TAD/SNB and Adjuvant Radiation Therapy

Clinical Study ID

NCT06092892
IIT2023-09-Chung-UpfrontTAD
  • Ages > 45
  • Female

Study 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

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 complywith the requirements of the study.

Exclusion

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 Design

Total Participants: 45
Treatment Group(s): 3
Primary Treatment: Adjuvant Radiation Therapy
Phase: 2
Study Start date:
April 07, 2024
Estimated Completion Date:
April 30, 2031

Connect with a study center

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • CS Cancer at Huntington Cancer Center

    Pasadena, California 91105
    United States

    Active - Recruiting

  • CS Cancer at Valley Oncology Medical Group

    Tarzana, California 91356
    United States

    Active - Recruiting

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