TAD/SNB in T1-2N0 ER+ Her2- Breast Cancer With Ultrasound-Detected Nodal

What is the Purpose of this Study?

This study focuses on women who have estrogen receptor-positive breast cancer with axillary nodal disease (cancer that has spread to a lymph node). The purpose of the study is to determine the safety and effectiveness of targeted axillary dissection (TAD) with sentinel node biopsy (SNB) in these patients. Researchers want to determine whether TAD/SNB leads to acceptable disease control and survival outcomes, while avoiding the risks of axillary lymph node dissection (ALND). The usual procedure is ALND, which can cause swelling, typically in the arm, hand, chest, back, breast, or underarm area, which may cause pain or discomfort or limit movement. TAD/SNB is a more limited lymph node surgery, which may decrease the risk of lymphedema. Participants will undergo is breast surgery (breast conserving surgery or mastectomy) with TAD/SNB. If needed, they will undergo subsequent ALND and/or an additional surgery to clear margins.


Eligibility

  • 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.
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Where can I participate?

  • Cedars-Sinai Cancer at SOCC : Nikki Kem-Bernard
  • Cedars-Sinai Cancer at Valley Oncology : Nikki Kem-Bernard


More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details
Disease Type/Condition

Breast

Principal Investigator

Chung, Alice

Co-Investigators

Amin Mirhadi, Armando Giuliano, Benjamin King, Catherine Dang, Farin Amersi, Johnny Chang, Julie Jang, Kjirsten Carlson, Lauren DeStefano, Marissa Boyle, Michele Burnison, Natasha Banerjee, Robert Reznik, Ryan Ponec, Scott Karlan, Stephen Shiao

Age Group

Adult

Phase

II

IRB Number

STUDY00003084

ClinicalTrials.gov ID

NCT06092892

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Nikki Kem-Bernard

Email
Nikki.Bernard@cshs.org
Study Detail
Disease Type/Condition

Breast

Principal Investigator

Chung, Alice

Age Group

Adult

Phase

II

IRB Number

IIT2023-09-CHUNG-UPFRONTTAD

ClinicalTrials.gov ID

NCT06092892

Key Eligibility
ClinicalTrials.gov

Contact
Name

Nikki Kem-Bernard

Email
Nikki.Bernard@cshs.org