# Capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer: the PAKT trial

Source: https://onco.cc/key-papers/paper-schmid-pakt-capivasertib-tnbc-jco-2020/  
OnCo record `paper-schmid-pakt-capivasertib-tnbc-jco-2020` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding capivasertib to first-line paclitaxel improved survival in metastatic triple-negative cancer from 12.6 to 19.1 months, with the largest gain in the fifth of patients whose tumours carried a PIK3CA, AKT1 or PTEN alteration.

## Summary

140 women with untreated metastatic TNBC were randomised to paclitaxel 90 mg/m2 with capivasertib 400 mg twice daily (days 2 to 5, 9 to 12, 16 to 19) or placebo. Median PFS was 5.9 versus 4.2 months (HR 0.74; one-sided P 0.06 against a 0.10 threshold) and median overall survival 19.1 versus 12.6 months (HR 0.61). In 28 patients with PIK3CA/AKT1/PTEN-altered tumours PFS was 9.3 versus 3.7 months (HR 0.30). Grade 3 or worse diarrhoea 13% versus 1%.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: Journal of Clinical Oncology
- Year: 2020
- DOI: 10.1200/JCO.19.00368
- Authors: Schmid P, Abraham J, Chan S, et al.
- Findings: PFS 5.9 versus 4.2 months (HR 0.74); overall survival 19.1 versus 12.6 months (HR 0.61).; PIK3CA/AKT1/PTEN-altered (28 of 140, 20%): PFS 9.3 versus 3.7 months (HR 0.30).
- What it means: PAKT gives the trial-based prevalence of PI3K-pathway alteration in first-line metastatic TNBC (one in five) and the strongest signal for AKT inhibition in that subgroup; the phase 3 CAPItello-290 did not confirm it.
- Caveats: Phase 2 with a lenient one-sided significance level.; Subgroup of 28 patients; CAPItello-290 was negative.

## Sources

- Schmid et al., J Clin Oncol 2020: PAKT, capivasertib plus paclitaxel in 140 metastatic TNBC patients: https://doi.org/10.1200/JCO.19.00368
- PubMed: https://pubmed.ncbi.nlm.nih.gov/31841354/

## Connected records

- biomarkers: [AKT1 E17K mutation](https://onco.cc/biomarkers/akt1-e17k/), [PIK3CA mutation](https://onco.cc/biomarkers/pik3ca-hotspot-mutation/), [PTEN alteration (sequencing) and PTEN loss (IHC)](https://onco.cc/biomarkers/pten-alteration/)
- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- 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/)
- pathways: [PI3K / AKT / mTOR](https://onco.cc/pathways/pi3k-akt-mtor/)
- people: [Peter Schmid](https://onco.cc/people/peter-schmid/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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