# evERA

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

## TL;DR

In evERA, pairing an oral SERD with everolimus after CDK4/6 failure delayed progression by more than three months, and by four and a half months in ESR1-mutant tumours.

## Summary

evERA, trial NCT05306340 sponsored by Roche and Genentech and reported at ESMO 2025, showed that pairing the oral SERD giredestrant with everolimus after CDK4/6 inhibitor failure in ER-positive, HER2-negative advanced breast cancer delayed progression by more than three months, and by about four and a half months in ESR1-mutant tumours. It randomised 320 women to giredestrant or standard endocrine therapy, each with everolimus, and met its primary progression-free survival endpoints in both the intention-to-treat and ESR1-mutant populations, after which the FDA accepted a new drug application for the ESR1-mutant indication in February 2026. OnCo links it to the oestrogen receptor, giredestrant, everolimus and exemestane, and the result is consistent with BOLERO-2 for the everolimus backbone. Whether the combination beats an oral SERD alone is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT05306340
- Phase: 3
- Setting: ER+/HER2- advanced breast cancer after CDK4/6 inhibitor: giredestrant + everolimus vs standard endocrine therapy + everolimus
- Sponsor: Roche / Genentech
- Enrolled: 320
- Result: PFS HR 0.56 (ITT); HR 0.38 (ESR1-mutant).
- Outcomes: Progression-free survival (ITT): Giredestrant + everolimus 8.77 months vs Standard ET + everolimus 5.49 months, HR 0.56; Progression-free survival (ESR1-mutant): Giredestrant + everolimus 9.99 months vs Standard ET + everolimus 5.45 months, HR 0.38
- Replication: Consistent with BOLERO-2 (everolimus + exemestane) as the backbone and with other oral SERDs in ESR1-mutant disease.

## Sources

- ClinicalTrials.gov NCT05306340: https://clinicaltrials.gov/study/NCT05306340

## Connected records

- 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/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/)
- targets: [Estrogen receptor (ERα)](https://onco.cc/targets/estrogen-receptor/)
- drugs: [Everolimus](https://onco.cc/drugs/everolimus/), [Exemestane](https://onco.cc/drugs/exemestane/), [Giredestrant](https://onco.cc/drugs/giredestrant/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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