RecruitingInterventionalPhase 2

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

NCT ID: NCT06092892Sponsor: Alice ChungLast updated: 2026-05-11

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.

Arms & interventions

ProcedureBreast Surgery (BCS or mastectomy) with TAD/SNB
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
RadiationAdjuvant Radiation Therapy
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy

Outcome measures

Primary

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

Secondary

Local recurrence rate
Time frame: 5 Years
Disease-free survival (DFS)
Time frame: 5 Years
Breast cancer specific survival (BCSS) rate
Time frame: 5 Years
Overall survival (OS)
Time frame: 5 Years

Eligibility criteria

Sex: FemaleAge: 45 Years and olderHealthy volunteers: No

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 locations (3)

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048

Recruiting

Clinical Trial Recruitment Navigator · Contact

310-423-3713 GroupCancerTrialInformation@cshs.org

Scott Karlan, MD · Sub Investigator

Armando Giuliano, MD · Sub Investigator

Catherine Dang, MD · Sub Investigator

Farin Amersi, MD · Sub Investigator

Alice Chung, MD · Principal Investigator

Marissa Boyle, MD · Sub Investigator

Kjirsten Carlson, MD · Sub Investigator

Stephen Shiao, MD PhD · Sub Investigator

Julie Jang, MD · Sub Investigator

Michele Burnison, MD · Sub Investigator

Amin Mirhadi, MD · Sub Investigator

CS Cancer at Huntington Cancer Center

Pasadena, California, 91105

Recruiting

· Contact

424-314-0177

Jeannie Shen, MD · Sub Investigator

Amy Polverini, MD · Sub Investigator

Alicia Terando, MD · Sub Investigator

CS Cancer at Valley Oncology Medical Group

Tarzana, California, 91356

Recruiting

Vanessa Vasco · Contact

Vanessa.Vasco@cshs.org

Lauren DeStefano, MD · Sub Investigator