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Posted On: 04/09/2019 5:55:31 PM
Post# of 154183
Quote:
Phase 1b/2 Trial for Triple-Negative Breast Cancer
We recently received clearance from the U.S. Food and Drug Administration (the “FDA”) for our IND submission to initiate a phase 1b/2 clinical trial for metastatic triple-negative breast cancer patients. We have identified five clinical trial sites and intend to dose its first several patients during the second quarter of calendar 2019. The change in circulating tumor cells (CTCs) number will be evaluated every 21 days during treatment and will be used as an initial prognostic marker for efficacy. Up to 48 patients are expected to be enrolled in this study.
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