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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Women age ≥ 45 - Clinical T1-2N0 ER+ invasive breast cancer - US detected biopsy proven axillary nodal disease - Written willing to sign a consent form obtained from subject and ability for subject to comply with the requirements of the study. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Breast Surgery (BCS or mastectomy) with TAD/SNB

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

RADIATION

Adjuvant Radiation Therapy

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

Locations (3)

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
CS Cancer at Huntington Cancer Center
Pasadena, California, United States
CS Cancer at Valley Oncology Medical Group
Tarzana, California, United States