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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(B-51)
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(B-51)
 
Region Sponsors
Northwest
NSABP Foundation Inc
 
Acronym KP IRB No.
Pro00000646
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Stage 1B Breast cancer, Stage II Breast Cancer
 
Purpose
To evaluate whether the addition of chest wall + regional nodal radiation therapy (XRT) after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.
 
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
  • Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing, if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing (http://www.asco.org)
  • Please contact study for more Inclusion details
 
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
  • Synchronous or previous contralateral invasive breast cancer or DCIS. (patients with synchronous and/or previous contralateral LCIS are eligible)
  • Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy, (patients with synchronous or previous ipsilateral LCIS are eligible)
  • Please contact study for more Exclusion details

 
Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Sandeep Mashru, MD
Contact Information:
- Rhonda Stephenson, RN
-503-331-6537
-rhonda.stephenson@kpchr.org
-Central Interstate Medical Office


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