# Capivasertib

Source: https://onco.cc/drugs/capivasertib/  
OnCo record `capivasertib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Capivasertib (Truqap) is the first AKT inhibitor, for breast cancer with PI3K-pathway mutations and, since 2026, for prostate cancer with PTEN loss.

## Summary

Capivasertib is an ATP-competitive pan-AKT inhibitor given intermittently at 400 mg twice daily for 4 days on and 3 days off, a schedule chosen to limit hyperglycaemia and rash. It was approved in 2023 with fulvestrant for HR-positive, HER2-negative advanced breast cancer carrying PIK3CA, AKT1 or PTEN alterations after CAPItello-291, and in Q2 2026 with abiraterone for PTEN-deficient metastatic hormone-sensitive prostate cancer after CAPItello-281, the first AKT inhibitor in either disease. AstraZeneca markets it. Diarrhoea (77%, 12% grade 3 or higher) and cutaneous reactions (56%, 15%) are the main toxicities. The breast label is limited to tumours with a pathway alteration, and sequencing against PI3K-alpha inhibitors such as inavolisib is unresolved. For a newcomer: a pill that blocks the AKT node of the PI3K pathway in tumours that have switched it on.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Truqap
- Modality: Small-molecule AKT inhibitor
- Mechanism: ATP-competitive pan-AKT inhibitor, intermittent 4-days-on/3-off dosing.
- Approvals: US 2023: HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alteration, with fulvestrant; US 2026: PTEN-deficient metastatic prostate cancer with abiraterone; EU 2024: ER+/HER2- mBC with PIK3CA/AKT1/PTEN alteration; 17 Jun 2024
- Dosing: Oral; 400 mg twice daily for 4 days on, 3 days off, with fulvestrant (breast) or abiraterone plus prednisone (prostate)
- Toxicity (grade 3+): Diarrhoea 12%; Cutaneous adverse reactions 15%; Fatigue 1.9%; Nausea 1.3%; Stomatitis 1.9%; Vomiting 1.9%

## Notes

- Triple-negative breast cancer: CAPItello-290 (812 patients, first-line paclitaxel with or without capivasertib) missed both overall survival endpoints (17.7 versus 18.0 months overall, hazard ratio 0.92; 20.4 months in both arms in PIK3CA, AKT1 or PTEN-altered tumours, hazard ratio 1.05) despite a progression-free survival signal (5.6 versus 5.1 months, hazard ratio 0.72), so the AKT inhibitor has no triple-negative indication and the NICE appraisal for untreated metastatic triple-negative disease (GID-TA11411) was discontinued. With IPATunity130 (ipatasertib) this closes the first-line AKT-inhibitor programme in triple-negative disease that the phase 2 PAKT and LOTUS trials had opened.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Capivasertib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Capivasertib
- CAPItello-290 (Annals of Oncology 2026): https://doi.org/10.1016/j.annonc.2025.12.012

## Connected records

- biomarkers: [AKT1 E17K mutation](https://onco.cc/biomarkers/akt1-e17k/), [ER status (oestrogen receptor by IHC)](https://onco.cc/biomarkers/er-status/), [PIK3CA mutation](https://onco.cc/biomarkers/pik3ca-hotspot-mutation/), [PTEN alteration (sequencing) and PTEN loss (IHC)](https://onco.cc/biomarkers/pten-alteration/)
- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/), [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Prostate cancer](https://onco.cc/cancers/prostate/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [PI3K, AKT and mTOR inhibitors](https://onco.cc/technologies/pi3k-akt-mtor-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [AKT](https://onco.cc/targets/akt/), [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/), [PTEN](https://onco.cc/targets/pten/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- trials: [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](https://onco.cc/trials/nct06764186/), [A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer](https://onco.cc/trials/nct03742102/), [CAPItello-281](https://onco.cc/trials/capitello-281/), [CAPItello-291](https://onco.cc/trials/capitello-291/), [Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)](https://onco.cc/trials/nct04862663/), [Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients](https://onco.cc/trials/nct06635447/), [Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC](https://onco.cc/trials/nct03997123/), [National Lung Matrix Trial](https://onco.cc/trials/national-lung-matrix-trial/), [NCI-MATCH (EAY131)](https://onco.cc/trials/nci-match/), [Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer](https://onco.cc/trials/nct05563220/), [PAKT](https://onco.cc/trials/pakt/), [plasmaMATCH](https://onco.cc/trials/plasmamatch/), [Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors](https://onco.cc/trials/nct07287917/), [Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)](https://onco.cc/trials/nct05348577/)
- key papers: [CAPItello-291: capivasertib plus fulvestrant in hormone receptor-positive advanced breast cancer](https://onco.cc/key-papers/paper-capitello-291-nejm-2023/), [Capivasertib plus paclitaxel as first-line treatment for metastatic triple-negative breast cancer: results from the randomised, global phase III CAPItello-290 trial](https://onco.cc/key-papers/paper-capitello-290-capivasertib-paclitaxel-ann-oncol-2026/), [Capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer: the PAKT trial](https://onco.cc/key-papers/paper-schmid-pakt-capivasertib-tnbc-jco-2020/)
- pairings: [PI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6)](https://onco.cc/pairings/pi3k-pathway-plus-endocrine/)
- ideas: [Molecular-progression switching beyond ESR1](https://onco.cc/ideas/idea-ctdna-switch-generalised/), [Start low and step up: individualised titration of oral cancer drugs, randomised](https://onco.cc/ideas/idea-tr1-start-low-titrate-up-oral-agents/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/)
- institutions: [The Institute of Cancer Research](https://onco.cc/institutions/icr-london/)
- pathways: [Androgen receptor signalling](https://onco.cc/pathways/ar-signaling/), [Breast cancer (KEGG map)](https://onco.cc/pathways/breast-cancer-signalling/), [Chemical carcinogenesis - receptor activation](https://onco.cc/pathways/chemical-carcinogenesis-receptor-activation/), [Choline metabolism in cancer](https://onco.cc/pathways/choline-metabolism-in-cancer/), [MicroRNAs in cancer](https://onco.cc/pathways/micrornas-in-cancer/), [PI3K / AKT / mTOR](https://onco.cc/pathways/pi3k-akt-mtor/), [Prostate cancer (KEGG map)](https://onco.cc/pathways/prostate-cancer-signalling/), [The blood-brain barrier & brain metastasis](https://onco.cc/pathways/blood-brain-barrier-metastasis/)
- people: [Nicholas Turner](https://onco.cc/people/nicholas-turner/), [Paul Workman](https://onco.cc/people/paul-workman/)
- terms: [Hyperglycaemia (PI3K/AKT inhibitor class effect)](https://onco.cc/terms/hyperglycaemia/), [PTEN loss](https://onco.cc/terms/pten-loss/)

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JSON: https://onco.cc/api/v1/entities/capivasertib.json