Therapy Detail
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| Therapy Name | Capivasertib + Paclitaxel |
| 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) 21 | 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). |
| Paclitaxel | Taxol | 7-Epipaclitaxel | Antimicrotubule Agent 14 BCL2 Family Inhibitor 6 | Taxol (paclitaxel) binds to tubulin to inhibit microtubule disassembly, which results in decreased cell division, and also binds to the anti-apoptotic factor Bcl-2, promoting apoptosis (NCI Drug Dictionary). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PTEN loss | triple-receptor negative breast cancer | predicted - sensitive | Capivasertib + Paclitaxel | Phase II | Actionable | In a Phase II trial (PAKT), addition of Truqap (capivasertib) to Taxol (paclitaxel) as first-line therapy significantly improved median progression-free survival (9.3 vs 3.7 months, HR=0.30, p=0.01) and reduced risk (66%, HR=0.34, p=0.04) compared to Taxol (paclitaxel) alone in patients with metastatic triple-negative breast cancer harboring activating mutations in AKT1 (n=1) or PIK3CA (n=17), or inactivating mutations or gene loss in PTEN (n=13) (PMID: 31841354; NCT02423603). | 31841354 |
| PIK3CA mutant | Her2-receptor negative breast cancer | no benefit | Capivasertib + Paclitaxel | Phase II | Actionable | In a Phase II trial, the addition of Truqap (capivasertib) to Taxol (paclitaxel) therapy did not improve progression-free survival compared to placebo (10.9 vs 10.8 months) in patients with PIK3CA-mutant, Esr1-positive, Erbb2 (Her2)-negative breast cancer (PMID: 30860570; NCT01625286). | 30860570 |
| PTEN inact mut | triple-receptor negative breast cancer | predicted - sensitive | Capivasertib + Paclitaxel | Phase II | Actionable | In a Phase II trial (PAKT), addition of Truqap (capivasertib) to Taxol (paclitaxel) as first-line therapy significantly improved median progression-free survival (9.3 vs 3.7 months, HR=0.30, p=0.01) and reduced risk (66%, HR=0.34, p=0.04) compared to Taxol (paclitaxel) alone in patients with metastatic triple-negative breast cancer harboring activating mutations in AKT1 (n=1) or PIK3CA (n=17), or inactivating mutations or gene loss in PTEN (n=13) (PMID: 31841354; NCT02423603). | 31841354 |
| PIK3CA act mut | triple-receptor negative breast cancer | predicted - sensitive | Capivasertib + Paclitaxel | Phase II | Actionable | In a Phase II trial (PAKT), addition of Truqap (capivasertib) to Taxol (paclitaxel) as first-line therapy significantly improved median progression-free survival (9.3 vs 3.7 months, HR=0.30, p=0.01) and reduced risk (66%, HR=0.34, p=0.04) compared to Taxol (paclitaxel) alone in patients with metastatic triple-negative breast cancer harboring activating mutations in AKT1 (E17K, n=1) or PIK3CA (n=17), or inactivating mutations or gene loss in PTEN (n=13) (PMID: 31841354; NCT02423603). | 31841354 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01625286 | Phase Ib/II | Capivasertib + Paclitaxel | Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients | Completed | GBR | FRA | ESP | CAN | 7 |
| NCT03997123 | Phase III | Paclitaxel Capivasertib + Paclitaxel | Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC (CapItello290) | Active, not recruiting | USA | GBR | FRA | ESP | CAN | 25 |
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