Recruiting
Phase 2

Upfront TAD

Sponsor:

Alice Chung

Code:

NCT06092892

Conditions

Breast Cancer

Axillary Nodal Disease

Female Breast Cancer

Axilla; Breast

Mastectomy; Lymphedema

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Breast Surgery (BCS or mastectomy) with TAD/SNB

Adjuvant Radiation Therapy

Study Details

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

Study ID

NCT06092892

Start date

Apr 7, 2024

Status verified date

Aug, 2026

Completion date

Apr, 2031

Anticipated

Primary completion date

Apr, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm

Interventions

Breast Surgery (BCS or mastectomy) with TAD/SNB

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

Adjuvant Radiation Therapy

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

Primary outcome measure

  • Regional recurrence rate [ Time Frame: 5 Years ]

Central Contacts and Locations

Central contacts

Clinical Trial Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Principal Investigator:

Alice Chung, MD

CS Cancer at Huntington Cancer Center

Recruiting

Pasadena, California, United States, 91105

Contacts

424-314-0177

CS Cancer at Valley Oncology Medical Group

Recruiting

Tarzana, California, United States, 91356

Contacts

Vanessa Vasco

Vanessa.Vasco@cshs.org

More Information

Sponsor

Alice Chung

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alice Chung on 2026-08-10.