Comparison of Axillary Lymph Node Dissection with Axillary Radiation for Patients with Node-Positive Breast Cancer Treated with Chemotherapy
- Conditions
- Stage II Breast CancerStage IIIA Breast Cancer
- Registration Number
- NCT01901094
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.
- Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive sentinel lymph node(s) (SLN\[s\]) after completion of neoadjuvant chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy.
II. To obtain an estimate of the distribution of residual disease burden scores.
III. To estimate the distribution of overall survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo axillary lymph node dissection. Beginning 3-12 weeks following surgery, patients undergo nodal radiation therapy comprising 3-dimensional (3D) conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), or proton radiation therapy (PRT) 5 days a week for 5-6 weeks.
ARM II: Patients undergo axillary and nodal radiation therapy comprising 3D-CRT, IMRT, or PRT 5 days a week for 5-6 weeks.
After completion of study treatment, patients are followed up at least every 6 months for 2 years and then annually for 3 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2012
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Invasive breast cancer recurrence-free interval (IBC-RFI) Up to 8 years after completion of radiation therapy
- Secondary Outcome Measures
Name Time Method Overall survival Up to 8 years after completion of radiation therapy Ipsilateral/local/regional invasive breast cancer recurrence (ILR-REC) Up to 8 years after completion of radiation therapy
Trial Locations
- Locations (1239)
Southern Cancer Center PC-Daphne
🇺🇸Daphne, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Southern Cancer Center PC-Mobile
🇺🇸Mobile, Alabama, United States
Southern Cancer Center PC-Providence
🇺🇸Mobile, Alabama, United States
Southern Cancer Center PC-Springhill
🇺🇸Mobile, Alabama, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Anchorage Associates in Radiation Medicine
🇺🇸Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
🇺🇸Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
🇺🇸Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
🇺🇸Anchorage, Alaska, United States
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