# Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

Source: https://onco.cc/trials/nct03997123/  
OnCo record `nct03997123` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Capivasertib in triple-negative breast cancer, run by AstraZeneca, active and no longer recruiting.

## Summary

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC is a phase 3 interventional study registered as NCT03997123 by AstraZeneca, with 923 participants enrolled, started 2019-06-25 and due to reach its primary completion in 2026-03-16. Interventions recorded: Capivasertib, Paclitaxel and Placebo.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Also known as: CAPItello-290
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03997123
- Phase: 3
- Setting: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.
- Sponsor: AstraZeneca
- Enrolled: 923
- Result: Overall survival 17.7 vs 18.0 months (HR 0.92, p 0.32) overall and 20.4 vs 20.4 months (HR 1.05) in PIK3CA/AKT1/PTEN-altered tumours; PFS 5.6 vs 5.1 months (HR 0.72).
- Outcomes: Overall survival, all patients: Capivasertib + paclitaxel 17.7 months vs Placebo + paclitaxel 18 months, HR 0.92; Overall survival, PIK3CA/AKT1/PTEN-altered tumours: Capivasertib + paclitaxel 20.4 months vs Placebo + paclitaxel 20.4 months, HR 1.05; Progression-free survival (investigator), all patients: Capivasertib + paclitaxel 5.6 months vs Placebo + paclitaxel 5.1 months, HR 0.72

## Notes

- Primary paper (Annals of Oncology 2026): 812 untreated metastatic patients randomised July 2019 to February 2022 to paclitaxel 80 mg/m2 with capivasertib 400 mg or placebo twice daily on days 2 to 5 of weeks 1 to 3; 30.7 percent had PIK3CA, AKT1 or PTEN alterations. Neither overall survival endpoint met its boundary; grade 3 or higher diarrhoea 12.7 versus 0.7 percent; adverse events led to death in 4.2 percent. UK sites (registry, 7): Edinburgh, London (3), Sheffield, Surrey, York. NICE appraisal GID-TA11411 discontinued.

## Sources

- ClinicalTrials.gov NCT03997123: https://clinicaltrials.gov/study/NCT03997123
- CAPItello-290 (Annals of Oncology 2026): https://doi.org/10.1016/j.annonc.2025.12.012

## 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: [PI3K, AKT and mTOR inhibitors](https://onco.cc/technologies/pi3k-akt-mtor-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Capivasertib](https://onco.cc/drugs/capivasertib/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- targets: [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/), [PTEN](https://onco.cc/targets/pten/)
- key papers: [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/)
- roadmaps: [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/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)
- trials: [BARBICAN](https://onco.cc/trials/barbican/), [IPATunity130](https://onco.cc/trials/ipatunity130/), [LOTUS](https://onco.cc/trials/lotus/), [PAKT](https://onco.cc/trials/pakt/)

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