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Clinical Trials

Topic   Cancer - Breast Cancer
Title   NRG-BR003: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node Negative Triple-Negative Breast Cancer
Summary   The aim of this study is to compare the good and bad effects of the chemotherapy drug, Carboplatin, given with the standard chemotherapy drugs after breast cancer surgery to the standard chemotherapy drugs given without Carboplatin. Carboplatin is Food and Drug Administration (FDA) approved for the treatment of breast cancer that has spread, but it has not yet proven useful in earlier stages of breast cancer. This study will allow researchers to learn if Carboplatin with standard chemotherapy is better, the same, or worse than standard chemotherapy.
Description   Patients will be randomized to one of two possible treatment regimens. Patients will receive Doxorubicin Plus Cyclophosphamide Followed by Paclitaxel or Doxorubicin Plus Cyclophosphamide followed by Paclitaxel and Carboplatin. Patients will be followed for 10 years.
IRB Number   795238
Inclusion/Notes   To be eligible to participate in this study, patients must meet several criteria, including but not limited to the following: 18 years of age or older; diagnosis of unilateral triple-negative invasive adenocarcinoma of the breast; mastectomy or lumpectomy, primary tumor pT1-3; ipsilateral lymph nodes pN0 – pN3b; if pN0, the tumor must be > 3 cm.
Status   Open
Start Date   09/24/2015
Principal Name   Nina D’Abreo, MD
Contact Name   Johanna Lee, RN
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1237
Alternate Phone   516-663-8391