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Old 05-23-2012, 11:14 AM   #1
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Join Date: Feb 2008
Location: South East Wisconsin
Posts: 3,431
Tesetaxel (oral) advances


Women were eligible if they had not received chemotherapy for locally advanced or metastatic HER2-negative breast cancer. Prior adjuvant chemotherapy was allowed if the recurrence was at least 12 months from the last dose. Forty-six patients were accrued to the trial, and 44 are currently evaluable for response. Seventy percent of patients had received adjuvant chemotherapy; more than 80% of those regimens had included an injectable taxane. More than 50% of patients had received local radiotherapy, and approximately two-thirds had progressed on one or more hormonal therapies.
Major objective responses were observed in 20 of 44 patients (45%), including 1 complete response and 19 partial responses. Seven of the major responders cleared more than 75% of their measurable disease. The disease-control/clinical-benefit rate, which includes major responders and patients with stable disease, was 82%.
Exploratory analyses showed that 17 of 35 patients (49%) whose disease was estrogen receptor positive (ER+) had major responses. Median progression-free survival in the ER+ population was 7.3 months. In women with "triple-negative" disease, which is relatively insensitive to chemotherapy, 3 of 9 patients responded (33%).
"Genta is also exploring an alternate dosing schedule in this population using weekly treatment
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