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 23 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 25 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
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 | ITA | GBR | ESP | CAN | BEL | AUS 9
NCT05392608 Phase II Alpelisib + Fulvestrant SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) (SEQUEL-Breast) Recruiting NLD 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
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
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
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
NCT05154487 Phase II Alpelisib + Fulvestrant A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer Recruiting USA 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 ITA | FRA | ESP | DEU | CAN | BEL 11
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 13
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 | GBR | FRA | ESP | DEU | CAN | BEL 10
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
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


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