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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 |
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).