Breast Cancer B-51

April 10, 2017

Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)

Number: B-51

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III trials are new treatments that have worked well in a small number of patients with this disease). This trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have already 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.

Who’s eligible: 

• Patients must have clinically T1-3 (stage), N1 (number of lymph nodes involved) breast cancer at the time of diagnosis before neo-adjuvant therapy (treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery). Clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, and/ or PET/CT scan.
• Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neo-adjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma/cancer that has spread into normal tissue). 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 neo-adjuvant therapy. Estrogen receptors are receptors that may be found in breast cancer cells. 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.
• This study is for women age 18 and older.

Available at: The Hospital of Central Connecticut, MidState Medical Center, and Hartford Hospital.