Cell Therapeutics announced interim results from a Phase 2 clinical trial of brostallicin in combination with cisplatin for the treatment of women with metastatic triple-negative breast cancer. Brostallicin is a novel synthetic second-generation DNA minor groove binder.
The study enrolled women with confirmed measurable metastatic disease and triple negative subtype breast cancer. At the time of data analysis, 48 women had been enrolled in the study and 47 were evaluable for efficacy. Approximately half of the patients had received between two and four prior chemotherapy regimens in the metastatic setting. The primary endpoint of the trial is 3-month progression-free survival (PFS). Secondary endpoints include overall response rate (ORR), duration of response, 6-month PFS, overall survival (OS) and safety. In this study, patients received cisplatin on Day 1, brostallicin on Day 2, and GCSF or pegylated-GCSF on Day 3, with the cycle repeated every 21 days. Key findings include:
- As of this analysis, 10 of 47 evaluable patients (21%) achieved a confirmed tumor response. Nine patients had a partial response (PR) and one confirmed response (CR).
- Despite the heavily pretreated population, 3-month PFS was at 51% and 6-month PFS is currently 26%.
- Median duration of response was 3.4 months; median time to progression was 3.2 months.
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