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Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
 
Region Sponsors
California - Northern
National Cancer Institute (NCI)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Radiation Therapy Oncology Group
 
Acronym KP IRB No.
CN-13-1630-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Stage IB Breast Cancer Stage II Breast Cancer
 
Purpose
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer
 
Detailed Description
 
Gender Age Limit
Female
 
Inclusion Criteria
  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy). Clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan
  • Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma). The FNA or core needle biopsy can be performed either by palpation or by image guidance. Documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
  • Patient must have completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
 
Exclusion Criteria
  • Definitive clinical or radiologic evidence of metastatic disease
  • T4 tumors including inflammatory breast cancer
  • Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone
  • N2 or N3 disease detected clinically or by imaging
  • Patients with histologically positive axillary nodes post neoadjuvant therapy
  • Patients with microscopic positive margins after definitive surgery

 
Keywords and/or Specific Medical Conditions
  • Breast Diseases
  • Neoplasms by Site
  • Breast Neoplasms
  • Skin Diseases
  • Neoplasms
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Valley-Modesto
  • Central Valley-Stockton
  • Diablo Medical Center-Antioch
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Fresno Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • Santa Teresa Medical Center-San Jose
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward
Contact Information:
- Beatriz Jio, RN
-(408) 851-4315
-Santa Clara Medical Center-Homestead
- Shanae Moffett, RN
-(510) 784-4533
-Fremont Medical Center
- Marion Cruz, RN
-(707) 651-2799
-Vallejo Medical Center


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