RecruitingPhase 2NCT06092892

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

Sponsor

Alice Chung

Enrollment

45 participants

Start Date

Apr 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the best approach to managing lymph nodes in the armpit for women with early-stage breast cancer that has spread to nearby lymph nodes, using a combination of targeted lymph node removal and sentinel node biopsy — surgical techniques to check whether cancer has spread — after chemotherapy before surgery. **You may be eligible if...** - You are a woman aged 45 or older - You have early-stage, hormone receptor-positive (ER+) invasive breast cancer (T1-2) - Imaging or biopsy has confirmed cancer spread to an armpit (axillary) lymph node - You have not yet had surgery or armpit lymph node treatment **You may NOT be eligible if...** - You have palpable (feelable) lymph nodes - Your cancer is HER2-positive or hormone receptor-negative (ER-) - The biopsy shows the cancer has spread beyond the lymph node wall by more than 3 mm - You have more than 2 suspicious lymph nodes on imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.