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|Therapy Name||Enzalutamide + Taselisib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Enzalutamide||Xtandi||MDV3100|ASP9785||Hormone - Anti-androgens 29||Xtandi (enzalutamide) is a second-generation small molecule androgen receptor (AR) inhibitor that inhibits AR signaling, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA approved for use in patients with castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer (FDA.gov).|
|Taselisib||RG7606|GDC-0032|RG-7604|RO5537381||PIK3CA inhibitor 16 PIK3CD inhibitor 24 PIK3CG inhibitor 8||Taselisib (GDC-0032) is a beta isoform-sparing PI3K inhibitor, with greater activity against oncogenic mutants of PIK3CA (PMID: 23662903, PMID: 31439579).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||triple-receptor negative breast cancer||not applicable||Enzalutamide + Taselisib||Phase Ib/II||Actionable||In a Phase Ib/II trial, the combination of Taselisib (GDC-0032) and Xtandi (enzalutamide) resulted in a clinical benefit rate of 35.7% (5/14) in patients with triple-negative breast cancer, with partial response in one patient and stable disease in 4 patients, compared to no clinical benefit with Xtandi (enzalutamide) alone, and PIK3CA mutations and AR expression did not correlate with response (PMID: 31822498; NCT02457910).||31822498|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02457910||Phase Ib/II||Enzalutamide Enzalutamide + Taselisib||Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer||Active, not recruiting||USA||0|