Spots Global Cancer Trial Database for Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
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Trial Identification
Brief Title: Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
Official Title: Phase I/II Study of Cisplatin Plus Romidepsin and Nivolumab in Metastatic Triple Negative Breast Cancer or BRCA Mutation-Associated Locally Recurrent or Metastatic Breast Cancer
Study ID: NCT02393794
Study Description
Brief Summary: Study combination use of cisplatin plus romidepsin and nivolumab in metastatic triple negative breast cancer (TNBC) or BRCA mutation-associated locally recurrent or metastatic breast cancer
Detailed Description: Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Despite recent improvement in the treatment of breast cancer, 40,000 women per year still die in the U.S.as a result of breast cancer. Once the disease has gotten worse (progressed) after standard chemotherapy treatments, there are limited treatment options and the likelihood for patients to recover is very small. The study will be done in two phases: Phase I will determine the highest dose of romidepsin that is safe and tolerable to take in combination with cisplatin. Phase II will determine if taking romidepsin (at the dose determined in Phase I) in combination with cisplatin and nivolumab is safe and effective in treating patients with breast cancer. Phase I will complete before Phase II begins.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Kansas Cancer Center - Clinical Research Center, Fairway, Kansas, United States
University of Kansas Cancer Center - West, Kansas City, Kansas, United States
University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States
University of Kansas Cancer Center - Westwood, Westwood, Kansas, United States
University of Kansas Cancer Center - South, Kansas City, Missouri, United States
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
Contact Details
Name: Priyanka Sharma, MD
Affiliation: University of Kansas Medical Center
Role: PRINCIPAL_INVESTIGATOR
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