Therapy Detail
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| Therapy Name | Alpelisib + Fulvestrant |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Alpelisib | Piqray | BYL719 | PIK3CA inhibitor 18 | Piqray (alpelisib) is a selective PIK3CA inhibitor that blocks activation of the PI3K signaling pathway and inhibits tumor growth (PMID: 23726034). Piqray (Alpelisib) is FDA approved in combination with fulvestrant for use in postmenopausal women, and men, with advanced or metastatic hormone receptor (HR)-positive, ERBB2 (HER2)-negative, PIK3CA-mutant breast cancer (FDA.gov). |
| Fulvestrant | Faslodex | ICI 182,780 | Hormone - Anti-estrogens 22 | 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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- Use quotes to match a longer phrase which contains spaces "mtor c1483f"
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04762979 | Phase II | Alpelisib + Fulvestrant | Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer | Recruiting | USA | 0 |
| NCT05090358 | Phase II | Alpelisib + Fulvestrant Alpelisib + Canagliflozin + Fulvestrant | Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer | Recruiting | USA | 0 |
| NCT01219699 | Phase I | Alpelisib Alpelisib + Fulvestrant | A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene | Completed | USA | ESP | DEU | 2 |
| NCT05038735 | Phase III | Alpelisib + Fulvestrant Fulvestrant | Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. (EPIK-B5) | Recruiting | ITA | FRA | ESP | DEU | BEL | 8 |
| NCT03056755 | Phase II | Alpelisib + Fulvestrant Alpelisib + Letrozole | Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 12 |
| NCT05154487 | Phase II | Alpelisib + Fulvestrant | A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer | Not yet recruiting | USA | 0 |
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