Window of Opportunity Trial of Apristor for PR+ Early Breast Cancer

Trial Status:
Initiation of this study targeted for October 2019.

Trial Titles:
Onward 203, ONAWA

Program (Target):
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.

Disease Indication:
Early stage breast cancer.

Clinical Trial Description:
A prospective, window of opportunity, single-arm, multicenter study assessing the effect of Apristor on breast cancer biology in women with early breast cancer.

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Trial Sites:

City Country Institution
Barcelona Spain Catalan Institute of Oncology
Barcelona Spain University Hospital Clinic of Barcelona
Barcelona Spain Vall d'Hebron Institute of Oncology (VHIO)
Valencia Spain Instituto Valenciano de Oncologia