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

NCT06092892 | Recruiting Phase 2 DMC

• 1 other identifier: IIT2023-09-Chung-UpfrontTAD
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer; Axillary Nodal Disease; Female Breast Cancer; Axilla; Breast; Mastectomy; Lymphedema; Tumor, Breast

Keywords

T1-2N0 ER+ invasive; biopsy; upfront lumpectomy

Outcome Measures

Primary Outcomes (1)

• Regional recurrence rate

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

  5 Years

Secondary Outcomes (4)

• Local recurrence rate

  5 Years

• Disease-free survival (DFS)

  5 Years

• Breast cancer specific survival (BCSS) rate

  5 Years

• Overall survival (OS)

  5 Years

Study Arms (1)

Single Arm

EXPERIMENTAL

Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB; Radiation: Adjuvant Radiation Therapy

Interventions

Breast Surgery (BCS or mastectomy) with TAD/SNB PROCEDURE

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

Single Arm

Adjuvant Radiation Therapy RADIATION

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

Single Arm

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alice Chung: lead

Study Sites (3)

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States

RECRUITING

CS Cancer at Huntington Cancer Center

Pasadena, California, 91105, United States

RECRUITING

CS Cancer at Valley Oncology Medical Group

Tarzana, California, 91356, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

Mastectomy, Segmental; Mastectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Alice Chung, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Navigator

CONTACT

3104232133; cancer.trial.info@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Open label, single arm

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: April 7, 2024
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)