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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
320 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (ITT)primary | Giredestrant + everolimus | - | 8.77 months | 0.56 (0.44 to 0.71) | <0.0001 | link |
| Standard ET + everolimus | - | 5.49 months | ||||
| Progression-free survival (ESR1-mutant)primary | Giredestrant + everolimus | - | 9.99 months | 0.38 (0.27 to 0.54) | <0.0001 | - |
| Standard ET + everolimus | - | 5.45 months |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Giredestrant, Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs).
Shares Giredestrant, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs), Roche / Genentech.
Shares Giredestrant, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
Shares Exemestane, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs).
Shares Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
Shares Exemestane, Everolimus, Endocrine therapy (SERMs, AIs, SERDs).
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/