Therapy Detail
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| Therapy Name | Fulvestrant + Gedatolisib + Palbociclib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| 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). |
| Gedatolisib | PKI-587|PF-05212384|PF 05212384 | mTOR Inhibitor 51 PI3K Inhibitor (Pan) 42 | Gedatolisib (PF-05212384) is an ATP-competitive inhibitor that targets phosphatidylinositol 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in the PI3K/mTOR signaling pathway, and may result in antitumor activity, including inhibition of tumor growth and tumor regression (PMID: 21325073, PMID: 31822716). | |
| Palbociclib | Ibrance | PD0332991|PD-0332991 | CDK4/6 Inhibitor 14 | Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05501886 | Phase III | Alpelisib + Fulvestrant Fulvestrant + Gedatolisib + Palbociclib Fulvestrant + Gedatolisib Fulvestrant | Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) (VIKTORIA-1) | Recruiting | USA | ROU | POL | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 5 |
| NCT06757634 | Phase III | Fulvestrant + Ribociclib Fulvestrant + Gedatolisib + Ribociclib Fulvestrant + Gedatolisib + Palbociclib Fulvestrant + Palbociclib | Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) | Recruiting | USA | TUR | ROU | POL | ITA | HUN | GRC | FRA | ESP | DEU | CZE | BRA | BGR | BEL | AUS | ARG | 6 |
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