Study Title
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
Malignancy
Breast Cancer, Early Breast Cancer, Node-positive breast cancer
Sponsor
Alliance for Clinical Trials in Oncology
Key Eligibility Criteria Details
- Stage T1-3 N1 M0 at diagnosis (prior to start of neoadjuvant chemotherapy)
- No inflammatory breast cancer
- No other malignancy within 5 years
- Must have received axillary ultrasound with bx or axillary lymph nodes prior to or within 14 days of starting neoadjuvant therapy
- Must have documented ER/PR/HER2 status before neoadjuvant therapy
- Must have completed all planned chemotherapy prior to trial (ie. no planned adjuvant therapy)
- Must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane based regimen
- HER2 positive patients must have received anti-HER2 therapy as part of neoadjuvant regimen
- Must have clinically negative axilla documented on physical exam at the completion of neoadjuvant chemotherapy (no imaging needed)
- No neoadjuvant endocrine or radiation therapy
- No history of prior breast cancer
- ECOG PS 0-1
- Must complete surgery within 56 days of finish of neoadjuvant therapy
- At least 1 sentinel lymph node identified intra-operatively with at least micromets
Objective
Primary- Invasive breast cancer recurrence-free interval; Secondary- OS, Local-regional recurrence