Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

Breast Cancer Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer

• NCT number: NCT02393794
• Study type: Interventional
• Source: University of Kansas Medical Center
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 17, 2015
• Completion date: July 2025