# PAKT

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

## TL;DR

PAKT, a UK-led trial run from Barts, found that adding the AKT-blocking tablet capivasertib to paclitaxel lengthened life in metastatic triple-negative breast cancer (19 versus 13 months), most clearly in tumours with PI3K-pathway mutations. The much larger CAPItello-290 trial then found no survival gain.

## Summary

PAKT (NCT02423603) was a double-blind, placebo-controlled randomised phase 2 trial sponsored by Queen Mary University of London with AstraZeneca and Cancer Research UK, which randomised 140 women with untreated metastatic triple-negative breast cancer 1 to 1 to paclitaxel 90 mg/m2 on days 1, 8 and 15 with capivasertib 400 mg or placebo twice daily on days 2 to 5, 9 to 12 and 16 to 19 of 28. Median progression-free survival was 5.9 versus 4.2 months (hazard ratio 0.74, 95 percent confidence interval 0.50 to 1.08, one-sided p 0.06 against a predefined level of 0.10) and median overall survival 19.1 versus 12.6 months (hazard ratio 0.61, 0.37 to 0.99, p 0.04). In the 28 patients with PIK3CA, AKT1 or PTEN-altered tumours median progression-free survival was 9.3 versus 3.7 months (hazard ratio 0.30, 0.11 to 0.79). Grade 3 or higher diarrhoea was 13 versus 1 percent. The trial recruited at 30 UK hospitals from Bangor and Belfast to the Royal Marsden and set up CAPItello-290, the 812-patient phase 3 with the same regimen, which in 2026 reported no overall survival difference in either the overall or the pathway-altered population.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Registry id: NCT02423603
- Phase: 2
- Setting: Untreated metastatic triple-negative breast cancer: first-line paclitaxel with capivasertib or placebo, UK-led academic phase 2 at 30 UK hospitals and sites in France, Georgia, Hungary, Romania and South Korea
- Sponsor: Queen Mary University of London, with AstraZeneca and Cancer Research UK
- Enrolled: 140
- Result: PFS 5.9 vs 4.2 months (HR 0.74); OS 19.1 vs 12.6 months (HR 0.61, p 0.04); PIK3CA/AKT1/PTEN-altered PFS 9.3 vs 3.7 months (HR 0.30). Not confirmed by CAPItello-290.
- Outcomes: Progression-free survival: Capivasertib + paclitaxel 5.9 months vs Placebo + paclitaxel 4.2 months, HR 0.74; Overall survival: Capivasertib + paclitaxel 19.1 months vs Placebo + paclitaxel 12.6 months, HR 0.61; Progression-free survival, PIK3CA/AKT1/PTEN-altered tumours: Capivasertib + paclitaxel 9.3 months vs Placebo + paclitaxel 3.7 months, HR 0.3
- Replication: Not replicated: CAPItello-290 (812 patients) found overall survival 17.7 vs 18.0 months overall and 20.4 vs 20.4 months in pathway-altered tumours.

## Notes

- UK sites (registry, 30): Bangor, Belfast, Bodelwyddan, Brighton, Cambridge, Canterbury, Cardiff (Velindre), Coventry, Edinburgh, Gillingham, Glasgow (Beatson), Leeds, London (Barts, University College London Hospitals, Barking Havering and Redbridge, Guy's and St Thomas', Lewisham and Greenwich, Royal Marsden) and others.

## Sources

- ClinicalTrials.gov NCT02423603: https://clinicaltrials.gov/study/NCT02423603
- Schmid et al., JCO 2020: capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic TNBC, the PAKT trial: https://doi.org/10.1200/JCO.19.00368

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [PI3K, AKT and mTOR inhibitors](https://onco.cc/technologies/pi3k-akt-mtor-inhibitors/)
- targets: [AKT](https://onco.cc/targets/akt/), [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/), [PTEN](https://onco.cc/targets/pten/)
- drugs: [Capivasertib](https://onco.cc/drugs/capivasertib/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- institutions: [Cancer Research UK](https://onco.cc/institutions/cruk/)
- pathways: [PI3K / AKT / mTOR](https://onco.cc/pathways/pi3k-akt-mtor/)
- trials: [Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC](https://onco.cc/trials/nct03997123/), [IPATunity130](https://onco.cc/trials/ipatunity130/), [LOTUS](https://onco.cc/trials/lotus/)

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