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

May 6, 2026 updated by: Alice Chung

IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
        • Principal Investigator:
          • Alice Chung, MD
        • Sub-Investigator:
          • Farin Amersi, MD
        • Sub-Investigator:
          • Catherine Dang, MD
        • Sub-Investigator:
          • Armando Giuliano, MD
        • Sub-Investigator:
          • Scott Karlan, MD
        • Sub-Investigator:
          • Amin Mirhadi, MD
        • Sub-Investigator:
          • Michele Burnison, MD
        • Sub-Investigator:
          • Kjirsten Carlson, MD
        • Sub-Investigator:
          • Marissa Boyle, MD
        • Sub-Investigator:
          • Julie Jang, MD
        • Sub-Investigator:
          • Stephen Shiao, MD PhD
        • Contact:
      • Pasadena, California, United States, 91105
        • Recruiting
        • CS Cancer at Huntington Cancer Center
        • Contact:
          • Phone Number: 424-314-0177
        • Sub-Investigator:
          • Jeannie Shen, MD
        • Sub-Investigator:
          • Amy Polverini, MD
        • Sub-Investigator:
          • Alicia Terando, MD
      • Tarzana, California, United States, 91356
        • Recruiting
        • CS Cancer at Valley Oncology Medical Group
        • Contact:
        • Sub-Investigator:
          • Lauren DeStefano, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB
Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy
Radiation: Adjuvant Radiation Therapy
Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional recurrence rate
Time Frame: 5 Years
Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence rate
Time Frame: 5 Years
Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.
5 Years
Disease-free survival (DFS)
Time Frame: 5 Years
Disease-free survival (DFS) is defined as the length of time after targeted axillary dissection (TAD) that the subject survives without any signs or symptoms of breast cancer.
5 Years
Breast cancer specific survival (BCSS) rate
Time Frame: 5 Years
Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period
5 Years
Overall survival (OS)
Time Frame: 5 Years
Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alice Chung

Investigators

  • Principal Investigator: Alice Chung, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2024

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2023-09-Chung-UpfrontTAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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