NATALEE
Extended CDK4/6 inhibitors to a broad group of early hormone-positive breast cancer patients, including node-negative.
iDFS HR 0.75 (4-year iDFS 88.5% vs 83.6%). Approved September 2024.
- 90.4 vs 87.1 out of 100 alive without the cancer coming back at 3 years with Ribociclib + NSAI compared with NSAI alone; 3.3 more per 100.
- Roughly one extra person helped for every 30 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 25 percent lower chance of the event at any given time (hazard ratio 0.75, likely range 0.62 to 0.91).
- 88.5 vs 83.6 out of 100 alive without the cancer coming back at 4 years with Ribociclib + NSAI compared with NSAI alone; 4.9 more per 100.
- Roughly one extra person helped for every 20 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 29 percent lower chance of the event at any given time (hazard ratio 0.715, likely range 0.609 to 0.84).
- 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: Adjuvant ribociclib 3 years + endocrine therapy in stage II-III HR+/HER2- breast cancer. 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.
5,101 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Invasive disease-free survival at 3 yearsprimary | Ribociclib + NSAI | 2,549 | 90.4% | 0.75 (0.62–0.91) | 0.003 | link |
| NSAI alone | 2,552 | 87.1% | ||||
| Invasive disease-free survival at 4 years | Ribociclib + NSAI | — | 88.5% | 0.715 (0.609–0.84) | — | link |
| NSAI alone | — | 83.6% |
Ribociclib is a second adjuvant CDK4/6 option, and the only one with data in node-negative stage II disease. Roughly 3 in 100 patients avoid a relapse or death at three years, so the decision depends heavily on individual risk, tolerance of a three-year oral drug, and cost. Whether the benefit persists after treatment ends, as it did with abemaciclib, needs longer follow-up.
Women with hormone-receptor-positive, HER2-negative breast cancer that has spread to lymph nodes and has other high-risk features can now be offered two years of abemaciclib alongside their hormone therapy, with a durable reduction in relapse. It does not apply to node-negative or low-risk disease, and the diarrhoea and cost are real trade-offs to discuss.