Clinical trial to study the efficacy and safety of Eribulin Mesylate taken with Pembrolizumab in patients with Triple-Negative Breast Cancer that has spread
This clinical trial will study the use of eribulin mesylate plus pembrolizumab in patients with triple-negative breast cancer that has spread after being previously treated with 0 to 2 chemotherapy regimens.
The first part of the study will include between 6 - 12 patients who will receive eribulin mesylate on Days 1 and 8 of a 21-day cycle andpembrolizumab on Day 1 of a 21-day cycle. The side effects will be assessed in the first cycle. The safest dose of eribulin mesylate + pembrolizumab will be determined for use in the second part of the study.
About 83 patients may be enrolled in the second part of the study to receive the safest dose combination as idenfied in part 1. Patients will be grouped into two groups: The first group received no prior chemotherapy for metastatic disease and the second group was previously treated with 1 to 2 lines of chemotherapy for metastatic disease.
The researchers will monitor the response rate after data is available for at least 38 subjects. The study could be stopped early if researches do not see enough benefit to continue. Pharmacokinetic (PK) testing of eribulin mesylate will be performed in all subjects in part 1 of the study. Subjects in the part 2 part will have less frequent PK sampling where feasible.
To enroll or if you have questions about participation