evERA
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.
ITT PFS 8.8 vs 5.5 months (HR 0.56, P<0.0001); ESR1-mutant 10.0 vs 5.5 months (HR 0.38). Presented ESMO 2025 (Berlin). FDA accepted the NDA for the ESR1-mutant indication (February 2026).
Setting
ER+/HER2- advanced breast cancer after CDK4/6 inhibitor: giredestrant + everolimus vs standard endocrine therapy + everolimus
Phase
Phase 3
Sponsor
Roche / Genentech
Registry
Headline result
PFS HR 0.56 (ITT); HR 0.38 (ESR1-mutant).
Reported
2025
Enrolled
320
Replication
Consistent with BOLERO-2 (everolimus + exemestane) as the backbone and with other oral SERDs in ESR1-mutant disease.
In plain words
What these results mean for people, not percentages
Progression-free survival (ITT)primarysurrogate endpoint
- Median 8.8 vs 5.5 months with Giredestrant + everolimus compared with Standard ET + everolimus; about 3.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 44 percent lower chance of the event at any given time (hazard ratio 0.56, likely range 0.44 to 0.71).
Progression-free survival (ESR1-mutant)primarysurrogate endpoint
- Median 10 vs 5.5 months with Giredestrant + everolimus compared with Standard ET + everolimus; about 4.5 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 62 percent lower chance of the event at any given time (hazard ratio 0.38, likely range 0.27 to 0.54).
Be careful
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: ER+/HER2- advanced breast cancer after CDK4/6 inhibitor: giredestrant + everolimus vs standard endocrine therapy + everolimus. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
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 participants enrolled.
Progression-free survival (ITT)primary
HR 0.56 (0.44–0.71) · p <0.0001
Giredestrant + everolimus
8.77 mo
Standard ET + everolimus
5.49 mo
Progression-free survival (ESR1-mutant)primary
HR 0.38 (0.27–0.54) · p <0.0001
Giredestrant + everolimus
9.99 mo
Standard ET + everolimus
5.45 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (ITT)primary | Giredestrant + everolimus | — | 8.77 months | 0.56 (0.44–0.71) | <0.0001 | link |
| Standard ET + everolimus | — | 5.49 months | ||||
| Progression-free survival (ESR1-mutant)primary | Giredestrant + everolimus | — | 9.99 months | 0.38 (0.27–0.54) | <0.0001 | — |
| Standard ET + everolimus | — | 5.45 months |
Replication
Consistent with BOLERO-2 (everolimus + exemestane) as the backbone and with other oral SERDs in ESR1-mutant disease.