CAPItello-291
Adding the AKT inhibitor capivasertib to fulvestrant doubled progression-free time, especially in tumours with PI3K-pathway mutations.
Overall PFS 7.2 vs 3.6 months (HR 0.60); in the AKT-pathway-altered population (PIK3CA/AKT1/PTEN, n=289) 7.3 vs 3.1 months (HR 0.50). About 70% had prior CDK4/6 inhibitors. FDA label restricted to the altered population (2023). Diarrhoea, rash, and hyperglycaemia are the main toxicities.
- Median 7.2 vs 3.6 months with Capivasertib + fulvestrant compared with Placebo + fulvestrant; about 3.6 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 40 percent lower chance of the event at any given time (hazard ratio 0.6, likely range 0.51 to 0.71).
- Median 7.3 vs 3.1 months with Capivasertib + fulvestrant compared with Placebo + fulvestrant; about 4.2 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 50 percent lower chance of the event at any given time (hazard ratio 0.5, likely range 0.38 to 0.65).
- 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: HR+/HER2- advanced breast cancer after aromatase inhibitor (± CDK4/6): capivasertib + fulvestrant vs placebo + fulvestrant. 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.
708 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (overall)primary | Capivasertib + fulvestrant | 355 | 7.2 months | 0.6 (0.51–0.71) | <0.001 | link |
| Placebo + fulvestrant | 353 | 3.6 months | ||||
| Progression-free survival (AKT-pathway-altered)primary | Capivasertib + fulvestrant | 155 | 7.3 months | 0.5 (0.38–0.65) | <0.001 | — |
| Placebo + fulvestrant | 134 | 3.1 months |
Pages like this
not linked directly; found by shared links- PairingPI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6)
Shares Fulvestrant, Capivasertib, AKT, PIK3CA / PI3K-alpha.
- TrialSOLAR-1
Shares Fulvestrant, PIK3CA / PI3K-alpha, HR-positive / HER2-negative breast cancer.
- TrialINAVO120
Shares Fulvestrant, PIK3CA / PI3K-alpha, HR-positive / HER2-negative breast cancer.
- PersonRamon E. Parsons
Shares AKT, PIK3CA / PI3K-alpha, HR-positive / HER2-negative breast cancer.
- TrialCAPItello-281
Shares Capivasertib, AKT.
- ProductGedatolisib
Shares AKT, PIK3CA / PI3K-alpha, HR-positive / HER2-negative breast cancer.
- TrialpostMONARCH
Shares Fulvestrant, HR-positive / HER2-negative breast cancer.
- TrialVERITAC-2
Shares Fulvestrant, HR-positive / HER2-negative breast cancer.