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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
Overall Recruitment Status: Enrollment complete
 
Official 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
 
Region Sponsors
California - Northern
Alliance for Clinical Trials in Oncology
 
Acronym NCT No.
NCT01901094
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
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
 
 
 
Inclusion Criteria
  • Pre-Registration Eligibility Criteria: Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition
  • All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy * Note: Biopsy of intramammary nodes does not fulfill eligibility criteria
  • Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy * Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled
 
Exclusion Criteria
  • No inflammatory breast cancer
  • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
  • No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy
  • No neoadjuvant radiation therapy
  • No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy
 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward
Contact Information:
- Desiree S Goldstein
-CTPCollaborate@kp.org
-Central Valley-Manteca


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