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Dec. 5, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported on interim results from a cooperative group sponsored Phase 2 clinical trial of brostallicin in combination with cisplatin for the treatment of women with metastatic triple-negative breast cancer that were presented at the San Antonio Breast Cancer Symposium (SABCS) held from
December 4-8, 2012.
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. The study is led by principal investigator Dr. Alvaro Moreno-Aspitia, Assistant Professor of Medicine, Mayo Clinic,
Jacksonville, FL. 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.
Adverse events were mostly hematologic (74.5%) and consistent with other treatments in this setting.
Triple-negative breast cancer lacks progesterone and estrogen receptors and the HER2 biomarker that is present in most breast cancers, which makes standard therapy with hormone or targeted therapy ineffective. The authors concluded that in this study the combination of brostallicin and cisplatin showed promising activity in heavily pretreated metastatic triple-negative breast cancer patients and achieved its primary endpoint comparing favorably to other Phase 2 clinical trials in this disease. Final results of this trial are expected to be presented at the American Society of Clinical Oncology 2013 Annual Meeting. A follow-up randomized Phase 2 trial is in development.