Phase 2 Trial in Women with ER+,PR+, Her2- mBC after Progression on Aromatase Inhibitors and CDK4/6 Inhibitors
Initiation of this Phase 2 study targeted for second half of 2019.
Apristor (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that Apristor has anticancer activity by inhibiting the binding of progesterone receptor to chromatin, downregulating cancer stem cell mobilization, and blocking immune evasion.
Apristor has not been approved for marketing by any regulatory authority.
Advanced breast cancer.
Clinical Trial Description:
A prospective, Phase 2 randomized control, multicenter study assessing the effect of Faslodex (fulvestrant) alone or in combination with Apristor in women with ER+,PR+, Her2- metastatic breast cancer after progression on the combination of an aromatase inhibitor and a Cdk4/6 inhibitor.