NSABP B-51

Trial

Clinical Trial Title

NSABP B-51

Trial Status

Open to Enrollment

Start Date

August 26, 2013

Location

Trial Type

Cancer (Oncology)

Specific Condition

Breast Cancer

Description

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall 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

Eligibility Criteria

  • Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma).  
  • Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).

  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy).

  • Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.

  •  HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible.

  • Patient must have completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.

  • For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization.

  •  Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.

  •  At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer.

IRB Number

Legacy IRB

Notes

Sponsored by: NSABP NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT

Principal Investigator Name

Jan Andersen, MD

Contact Name

Legacy Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Last Updated: Wednesday, September 18, 2013 01:30:45 PM

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