Upfront Surgery and Radiation for Breast Cancer with Nodal Metastases

This study is looking at a specific treatment approach for women aged 45 or older with a certain type of breast cancer (clinical T1-2N0 ER+ invasive breast cancer) that has spread to the lymph nodes (axillary nodal disease). You cannot have HER2+ or ER- breast cancer to join. The study will involve breast surgery (either a lumpectomy or mastectomy) along with TAD/SNB (Targeted Axillary Dissection/Sentinel Node Biopsy) and then radiation therapy. The main goal is to see how many patients experience the cancer returning in the region (regional recurrence) after 5 years. The study plans to enroll 45 participants, but its current status is unclear.

Study design
This is a single-arm Phase II clinical trial, meaning all participants will receive the same treatment. It plans to enroll 45 participants.
What's involved
You would undergo breast surgery (lumpectomy or mastectomy) with TAD/SNB, followed by adjuvant radiation therapy. Patient, tumor, and treatment data will be documented.
Compensation
Not stated in the trial record.
Follow-up
The study will measure regional recurrence rates at 5 years, suggesting follow-up for at least that long.

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NCT06092892

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

Recruiting
PHASE2Ages 45+InterventionalTreatment
Alice Chung
~45 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Breast Surgery (BCS or mastectomy) with TAD/SNBAdjuvant Radiation Therapy

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Regional recurrence rate
Measured over 5 Years
Breast Cancer
Axillary Nodal Disease
Female Breast Cancer
Axilla; Breast
Mastectomy; Lymphedema
Tumor, Breast
3 sites across 1 states
California3
  • Alice Chung, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

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Eligibility criteria

Inclusion

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

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
  • Regional recurrence rate5 Years

    Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.