# CAPItello-291: capivasertib plus fulvestrant in hormone receptor-positive advanced breast cancer

Source: https://onco.cc/key-papers/paper-capitello-291-nejm-2023/  
OnCo record `paper-capitello-291-nejm-2023` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the AKT inhibitor capivasertib to fulvestrant doubled the time to progression in advanced hormone receptor-positive breast cancer after aromatase inhibitor failure, with the largest gain in tumours with PIK3CA, AKT1 or PTEN alterations.

## Summary

Phase 3 placebo-controlled trial of 708 patients with hormone receptor-positive, HER2-negative advanced breast cancer that had relapsed or progressed on an aromatase inhibitor, about 70 percent after a CDK4/6 inhibitor, randomised to capivasertib or placebo with fulvestrant.

Median progression-free survival was 7.2 versus 3.6 months overall (hazard ratio 0.60) and 7.3 versus 3.1 months in the AKT pathway-altered population (hazard ratio 0.50). Diarrhoea, rash and hyperglycaemia were the main toxicities.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2023
- DOI: 10.1056/NEJMoa2214131
- Authors: Turner NC, Oliveira M, Howell SJ, et al.
- Findings: Median progression-free survival 7.2 vs 3.6 months overall; hazard ratio 0.60.; AKT pathway-altered: 7.3 vs 3.1 months; hazard ratio 0.50.
- What it means: Capivasertib-fulvestrant is a standard option for tumours with PIK3CA, AKT1 or PTEN alterations after a CDK4/6 inhibitor, adding a second targeted pathway to endocrine therapy.
- Caveats: Approval was limited to pathway-altered tumours because benefit in non-altered disease was uncertain.; Overall survival data were immature.

## Sources

- N Engl J Med 2023: https://doi.org/10.1056/NEJMoa2214131
- PubMed: https://pubmed.ncbi.nlm.nih.gov/37256976/

## Connected records

- cancers: [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- drugs: [Capivasertib](https://onco.cc/drugs/capivasertib/)
- trials: [CAPItello-291](https://onco.cc/trials/capitello-291/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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