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Title:
B51 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
Protocol Number:
NCTNB51
Phase:
Phase III
Physician:
Jean Wright
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Suburban Hospital
Purpose:
The main purpose of this clinical trial is to study women who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only to the breast at keeping breast cancer from returning, and 2) if, after mastectomy, radiation to the area where the breast used to be and to the lymph nodes is better than no radiation at keeping breast cancer from returning.
Eligibility:
Generally healthy women with breast cancer that has axillary node involvment before receiving neoadjuvant chemotherapy but no axillary node involvement at the time of surgery may be eligible.
Treatment:
Enrolled patients who had a lumpectomy will receive whole breast irradiation and randomized to receive regional node or no additional radiation therpay.Enrolled patients who had a mastectomy will be randomized to either get chestwall with regional node radiation therapy or no radiation therapy.Randomized means that you are put into a study arm by chance, like flipping a coin.If you receive radiation therapy, your radiation therapy will take approximately 5 to 6½ weeks depending in which Group you are placed. All patients will be asked to return to the office for follow-up physical exams and mammograms for up to 10 years from the time you joined the study. Keeping in touch with you and checking on your condition helps us to look at the long-term effects of the study therapy.
Population:
Adult
Last Update
03/05/2019 05:03 AM