Research & Trial Information
Protocol#: NSABP – B-51
Cancer Type: Neo-Adjuvant
- Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)
- Submission of tumor samples is required for all patients. Therefore, the local pathology department policy regarding release of tumor samples must be considered in the screening process. Patients whose tumor samples are located in a pathology department that by policy will not submit any samples for research purposes should not be approached for participation in the B-51/1304 trial.
- The patient must be female and must be ≥ 18 years old.
- The patient must have an 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, MRI, 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 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.
- Patients must have had ER analysis performed on the primary breast tumor before neoadjuvant therapy.
- Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy.
- Patient must have completed a minimum of 8 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. (If treatment delays occur, chemotherapy must be completed within 14 weeks.) The dose and schedule of the adjuvant chemotherapy are at the investigator’s discretion.
- Patients with HER2-positive tumors must have received neoadjuvant 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. Acceptable procedures for assessment of axillary nodal status at the time of surgery include:• axillary node dissection;• sentinel node biopsy alone provided that at least 2 sentinel lymph nodes are removed. Removal of at least 3 sentinel lymph nodes and use of dual tracer for lymphatic mapping are strongly recommended; or
• sentinel node biopsy followed by axillary node dissection.
- Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible.
- Patient who have undergone either a total mastectomy or a lumpectomy are eligible. (Patients who have had a nipple-sparing mastectomy are eligible.).
- For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist. Additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.).
- For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor.
- The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days.
- The patient must have recovered from surgery with the incision completely healed and no signs of infection.
- If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved.
- No definitive clinical or radiologic evidence of metastatic disease.
- No T4 tumors including inflammatory breast cancer.
- No axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone.
- No N2 or N3 disease detected clinically or by imaging.
- No histologically positive axillary nodes post neoadjuvant therapy.
- No microscopic positive margins after definitive surgery.
- No Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
- No 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.)
- No history of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.
- No radiation therapy for the currently diagnosed breast cancer prior to randomization.
- No prior breast or thoracic RT for any condition.
- No active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- No non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
- No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.