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The first CDK4/6 inhibitor to reduce recurrence after surgery in high-risk hormone-positive breast cancer.
monarchE, trial NCT03155997 sponsored by Eli Lilly and reported in 2020, produced the first CDK4/6 inhibitor to reduce recurrence after surgery in high-risk, node-positive HR-positive, HER2-negative early breast cancer. It randomised 5,637 patients to two years of abemaciclib plus endocrine therapy or endocrine therapy alone, met its primary invasive disease-free survival endpoint at two years with the benefit widening at five years in a carry-over effect, and improved distant relapse-free survival, with overall survival trending favourably but not yet significant. OnCo links it to HR-positive breast cancer, abemaciclib, Stephen Johnston, Nadia Harbeck, Miguel Martín, the lymph node status term, the idea of using residual disease tests to decide who needs ten years of hormone therapy and the monarchE and NATALEE papers. Whether the benefit becomes a survival benefit 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.
5,637 enrolled.
Step lines join published landmark estimates; the true curve between them is not shown.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Invasive disease-free survival at 2 yearsprimary | Abemaciclib + endocrine therapy | 2,808 | 92.2% | 0.75 (0.6 to 0.93) | 0.01 | link |
| Endocrine therapy alone | 2,829 | 88.7% | ||||
| Invasive disease-free survival at 5 years | Abemaciclib + endocrine therapy | - | 83.6% | 0.68 (0.6 to 0.77) | - | link |
| Endocrine therapy alone | - | 76% | ||||
| Distant relapse-free survival at 5 years | Abemaciclib + endocrine therapy | - | 86% | 0.675 | - | link |
| Endocrine therapy alone | - | 79.2% |
A second publication from the monarchE 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.
This is the paper Europe PMC returns for registry id NCT03155997 with the most citations, so it is the natural first reading for anyone following the monarchE trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
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 Miguel Martín, High-risk early HR-positive breast cancer, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors.
Shares Abemaciclib, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.
Shares Abemaciclib, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.