Clinical Trials

Title   RTOG 1304/NSABP B-51
Principal Investigator/ Physician   Weisi Yan, MD
Protocol┬áNo.   RTOG 1304
Open Date   03/01/2014
Gender   Female
Cancer Site   Breast
Status   Open
Sponsor   NRG
Contact Email   MCI Clinical Trials
Summary  

Protocol 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 ChemotherapyWho Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy."

Inclusion Criteria: ECOG performance status of 0 or 1; patient must have clinically T1-3, N1 breast cancer at the time of diagnosis; must have pathologic onfirmation of axillary nodal involvement at presentation; ER analysis performed on the primary breast tumor before neoadjuvant therapy; HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy; completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of 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 HER+ tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy; at the time of surgery, all removed axillary nodes must be histologically free from cancer; for patients who undergo mastectomy, that margins must be histologically free of residual tumor

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 microscopic positive margins after definitive surgery; any prior history of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; history of non-malignancies; any radiation therapy for currently diagnosed breast cancer prior to randomization; prior breast or thoracic radiation therapy for any condition; active collagen vascular disease

 

Clinical Trails.GovLink: https://clinicaltrials.gov/ct2/show/NCT01872975?term=nsabp+b-51&rank=1

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