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 24 | 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 29 | 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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| 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 |
| NCT05646862 | Phase III | Alpelisib + Fulvestrant Fulvestrant + Inavolisib | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) | Recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 6 |
| NCT05625087 | Phase II | Fulvestrant + Ribociclib Alpelisib + Fulvestrant | Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib (SAFIR 03) | Recruiting | FRA | 0 |
| NCT05392608 | Phase II | Alpelisib + Fulvestrant | SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) (SEQUEL-Breast) | Recruiting | NLD | 0 |
| 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 | SVK | ROU | POL | ITA | IRL | HUN | GRC | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BGR | BEL | 1 |
| 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 | NLD | GBR | ESP | DEU | 0 |
| 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 |
| NCT05933395 | Phase II | Abemaciclib + Fulvestrant Fulvestrant + Neratinib Alpelisib + Fulvestrant Everolimus + Fulvestrant | Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor (GERTRUDE) | Recruiting | USA | 0 |
| 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 Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve) | Active, not recruiting | USA | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | BEL | ARG | 7 |
| NCT05154487 | Phase II | Alpelisib + Fulvestrant | A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer | Recruiting | USA | 0 |
| NCT05090358 | Phase II | Alpelisib + Fulvestrant Alpelisib + Canagliflozin + Fulvestrant | Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
| NCT05826964 | Phase II | Everolimus + Fulvestrant Exemestane + Ribociclib Everolimus + Tamoxifen Fulvestrant + Ribociclib Everolimus + Exemestane Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Alpelisib + Letrozole Abemaciclib + Exemestane Fulvestrant + Palbociclib Alpelisib + Fulvestrant Letrozole + Palbociclib Exemestane + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Fulvestrant | Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer | Recruiting | USA | 0 |
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