Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy
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ClinicalTrials.gov Identifier: NCT01901094 |
Recruitment Status :
Active, not recruiting
First Posted : July 17, 2013
Last Update Posted : February 26, 2024
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Tracking Information | ||||
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First Submitted Date ICMJE | July 12, 2013 | |||
First Posted Date ICMJE | July 17, 2013 | |||
Last Update Posted Date | February 26, 2024 | |||
Actual Study Start Date ICMJE | February 7, 2014 | |||
Estimated Primary Completion Date | January 1, 2025 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Invasive breast cancer recurrence-free interval (IBC-RFI) [ Time Frame: Up to 8 years after completion of radiation therapy ] | |||
Original Primary Outcome Measures ICMJE |
Invasive breast cancer recurrence-free interval (IBC-RFI) [ Time Frame: Time from randomization to the first of the following events: invasive ipsilateral, local, regional, or distant recurrence and death due to breast cancer or treatment, assessed up to 5 years after completion of radiation therapy ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy | |||
Official Title ICMJE | 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 | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
2012 | |||
Original Estimated Enrollment ICMJE |
2918 | |||
Estimated Study Completion Date ICMJE | January 1, 2025 | |||
Estimated Primary Completion Date | January 1, 2025 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Pre-Registration Eligibility Criteria:
Intra-Operative Registration/Randomization Criteria:
Post-Operative Registration/Randomization Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01901094 | |||
Other Study ID Numbers ICMJE | A011202 U10CA031946 ( U.S. NIH Grant/Contract ) NCI-2013-00875 ( Registry Identifier: Clinical Trial Reporting Program ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Alliance for Clinical Trials in Oncology | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Alliance for Clinical Trials in Oncology | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Alliance for Clinical Trials in Oncology | |||
Verification Date | February 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |