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Clinical Trial NU 15B01

Title
A Single Arm Phase II Study Evaluating the Efficacy and Safety of Durvalumab (MEDI4736) in Combination with Tremelimumab in Patients with Metastatic HER2 Negative Breast Cancer: TNBC Expansion Cohort
Principal Investigator
Massimo Cristofanilli
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.NU 15B01
Purpose
The main purpose of this study is to determine the effects, both good and/or bad, of MEDI4736 in combination with Tremelimumab in treating metastatic HER2 negative breast cancer.
Overview
Both MEDI4736 and Tremelimumab are “investigational” drugs, which means that the drugs are not approved by the Food and Drug Administration (FDA). Both drugs are type of antibody (protein used by the immune system) therapy that have different functions (jobs). MEDI4736 attaches to a protein in tumors. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor. Combining the jobs of these drugs may result in better treatment options for this type of breast cancer.
Eligibility
Some of the eligibility criteria include:
  • Participants must be females 18 years of age or older.
  • Participants must have Her2 negative metastatic (cancer has spread) breast cancer.
  • Participants may not have had treatment for their disease within 4 weeks of being considered for this study. Please contact the study team for additional information about prior treatment.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants will receive both drugs for 4 doses every 4 weeks (about 4 months). Both drugs are given intravenously (through a vein). Participants who remain on the study will then receive only MEDI4736 every 2 weeks for up to 18 doses (about 6 months). Participants will remain on study unless their disease worsens, they choose to stop, or the study doctor feels it is in their best interest to stop.
Contact
Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 19-Oct-17 07:47 AM

 

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