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| Therapy Name | Buparlisib + Fulvestrant |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Buparlisib | BKM-120|BKM120 | PI3K Inhibitor (Pan) 42 | Buparlisib (BKM120) specifically inhibits class I PI3K in the PI3K/AKT kinase (or protein kinase B) signaling pathway in an ATP-competitive manner, and may result in apoptotic activity and inhibition of cell proliferation (PMID: 22188813). | |
| Fulvestrant | Faslodex | ICI 182,780 | Hormone - Anti-estrogens 31 | Faslodex (fulvestrant) is a competitive inhibitor of estrogen that binds and deforms estrogen receptors, and causes inhibition of growth in cultured estrogen-sensitive breast cancer cells and is FDA approved for use in patients with hormone receptor-positive breast cancer (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01633060 | Phase III | Fulvestrant Buparlisib + Fulvestrant | A Phase III Study of BKM120 With Fulvestrant in Patients With HR+, HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi | Terminated | USA | SWE | POL | NOR | NLD | LBN | ITA | HUN | GRC | GBR | FRA | FIN | ESP | DEU | CAN | BGR | BEL | AUT | ARG | 3 |
| NCT01610284 | Phase III | Buparlisib + Fulvestrant Fulvestrant | Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor (BELLE-2)r | Completed | USA | SVK | POL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 9 |