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NCT Number: NCT06092892

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

Recruiting

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Key information

Conditions

Breast Cancer Axilla; Breast Axillary Nodal Disease Breast Diseases Breast Neoplasms Female Breast Cancer Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Mastectomy; Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Tumor, Breast

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast Surgery (BCS or mastectomy) with TAD/SNB

Procedure

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

Adjuvant Radiation Therapy

Radiation

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Navigator

CONTACT

[email protected]

3104232133

Sponsors and collaborators

Lead sponsor

Alice Chung

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Oct 23, 2023
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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