MONARCH 3
Abemaciclib roughly doubled the time to progression when added to an aromatase inhibitor; the survival gain of about 13 months narrowly missed statistical significance.
PFS 28.2 vs 14.8 months (HR 0.54). Final OS 66.8 vs 53.7 months (HR 0.80, P=0.066), not statistically significant at the prespecified threshold despite a 13-month numerical difference.
- Median 28.2 vs 14.8 months with Abemaciclib + NSAI compared with Placebo + NSAI; about 13.4 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 46 percent lower chance of the event at any given time (hazard ratio 0.54, likely range 0.42 to 0.7).
- 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.
- Median 66.8 vs 53.7 months with Abemaciclib + NSAI compared with Placebo + NSAI; about 13.1 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 20 percent lower chance of the event at any given time (hazard ratio 0.8, likely range 0.62 to 1.03).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: First-line postmenopausal HR+/HER2- advanced breast cancer: abemaciclib + NSAI vs placebo + NSAI. 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.
493 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Abemaciclib + NSAI | 328 | 28.2 months | 0.54 (0.42–0.7) | — | link |
| Placebo + NSAI | 165 | 14.8 months | ||||
| Overall survival | Abemaciclib + NSAI | — | 66.8 months | 0.8 (0.62–1.03) | 0.066 | — |
| Placebo + NSAI | — | 53.7 months |
Pages like this
not linked directly; found by shared links- TrialPALOMA-2
Shares Letrozole (and other aromatase inhibitors), CDK4/6, HR-positive / HER2-negative breast cancer.
- TrialpostMONARCH
Shares Abemaciclib, CDK4/6, HR-positive / HER2-negative breast cancer.
- TrialMONALEESA-2
Shares Letrozole (and other aromatase inhibitors), CDK4/6, HR-positive / HER2-negative breast cancer.
- PersonWendy Parulekar
Shares Letrozole (and other aromatase inhibitors), HR-positive / HER2-negative breast cancer.
- IdeaCDK4-selective inhibitors as the new first-line backbone
Shares Abemaciclib, CDK4/6, HR-positive / HER2-negative breast cancer.
- IdeaRandomised lower-dose trials for approved drugs with quality of life as the primary endpoint
Shares Abemaciclib, Wrong doses.
- TrialEMBER-3
Shares Abemaciclib, CDK4/6, HR-positive / HER2-negative breast cancer.
- IdeaStart low and step up: individualised titration of oral cancer drugs, randomised
Shares Abemaciclib, Wrong doses.