Therapy Detail
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| Therapy Name | Capivasertib + Fulvestrant |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Capivasertib | Truqap | AZD5363|AZD 5363|AZD-5363 | Akt Inhibitor (Pan) 22 | Truqap (capivasertib) decreases PI3K/AKT/mTOR signaling by inhibition of AKT1, AKT2, and AKT3, potentially resulting in decreased cell proliferation (PMID: 22294718, PMID: 32532747, PMID: 32312891). Truqap (capivasertib) in combination with Faslodex (fulvestrant) is FDA-approved for use in patients with hormone receptor-positive, ERBB2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations (FDA.gov). |
| 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). |
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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 |
|---|---|---|---|---|---|---|
| NCT06607757 | Phase II | Fulvestrant Capivasertib + Fulvestrant | Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer | Recruiting | DEU | 0 |
| NCT06982521 | Phase III | Fulvestrant + RLY-2608 Capivasertib + Fulvestrant | Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (ReDiscover-2) | Recruiting | USA | 0 |
| NCT06764186 | Phase III | Capivasertib + Fulvestrant | A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain (CAPItana) | Recruiting | ESP | 0 |
| NCT03310541 | Phase I | Capivasertib Capivasertib + Enzalutamide Capivasertib + Fulvestrant | AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations | Completed | USA | 0 |
| NCT04305496 | Phase III | Capivasertib + Fulvestrant Fulvestrant | Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer (CAPItello-291) | Active, not recruiting | USA | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BEL | AUS | ARG | 6 |
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