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Cell Therapeutics Inc Reports Final Results from Cooperative Group and NCI-Sponsored Trial of Brostallicin in Patients with Metastatic Triple-Negative Breast Cancer


Saturday, 1 Jun 2013 07:30am EDT 

Cell Therapeutics Inc reported on final results from a cooperative group and NCI-sponsored Phase 2 clinical trial of brostallicin in combination with cisplatin for the treatment of women with metastatic triple-negative breast cancer (mTNBC). 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 rationale for the present study in TNBC is based on data the demonstrating that silencing of the breast cancer susceptibility gene(s) (BRCA) is associated with substantially enhanced sensitivity to brostallicin. BRCA is silenced or mutated in most patients with TNBC. In this study of 48 patients with heavily pretreated mTNBC, the 3-month progression free survival (PFS) was 51% with 10 confirmed responses (one complete response and nine partial responses). Among the 25 patients who received a reduced brostallicin dose, the overall response rate (ORR) was 28%, with 3-month progression-free survival (PFS) of 61.5% and median overall survival (OS) of 11.8 months. The study enrolled women with confirmed measurable metastatic disease and triple-negative subtype breast cancer. A total of 48 women were 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. 

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2.79
0.28 +11.16%
4:00pm EDT