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Extended CDK4/6 inhibitors to a broad group of early hormone-positive breast cancer patients, including node-negative.
NATALEE, trial NCT03701334 sponsored by Novartis and published in the New England Journal of Medicine in 2023, extended adjuvant CDK4/6 inhibitors to a broad group of stage II to III HR-positive, HER2-negative early breast cancer patients, including those with node-negative disease. It randomised 5,101 patients to three years of ribociclib plus a non-steroidal aromatase inhibitor or the aromatase inhibitor alone, met its primary invasive disease-free survival endpoint at three years with the benefit growing at four years, and led to approval in September 2024. OnCo links it to HR-positive breast cancer, ribociclib, Gabriel N. Hortobagyi, Dennis J. Slamon, the bottleneck of dormant cells and the monarchE and NATALEE papers. Whether three years of a costly drug is justified in lower-risk patients 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.
5,101 enrolled.
Step lines join published landmark estimates; the true curve between them is not shown.
Curves show the trial population; they are not a prediction for any one person.
| 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 to 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 to 0.84) | - | link |
| NSAI alone | - | 83.6% |
A second publication from the NATALEE trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
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.
Shares monarchE: two years of abemaciclib after surgery in high-risk, hormone-receptor-positive early breast cancer, NATALEE: three years of ribociclib after surgery in a broad population of hormone-receptor-positive early breast cancer, Surrogate endpoint validation: which stand-ins have earned trust, High-risk early HR-positive breast cancer.
Shares Gabriel N. Hortobagyi, Ribociclib, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors.
Shares High-risk early HR-positive breast cancer, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Dormant cells and minimal residual disease, HR-positive / HER2-negative breast cancer.
Shares Ribociclib, CDK4/6 inhibitors, Novartis, HR-positive / HER2-negative breast cancer.
Shares Ribociclib, CDK4/6 inhibitors, Novartis.
Shares High-risk early HR-positive breast cancer, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares Ribociclib, CDK4/6 inhibitors, Novartis.
Shares High-risk early HR-positive breast cancer, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, HR-positive / HER2-negative breast cancer.