Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02393794
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.
Study:
NCT02393794
Study Brief:
Protocol Section:
NCT02393794