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A phase 3 trial of Abemaciclib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Eli Lilly and Company, active and no longer recruiting.
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer is a phase 3 interventional study registered as NCT02107703 by Eli Lilly and Company, with 669 participants enrolled, started 2014-07-22 and due to reach its primary completion in 2017-02-14. Interventions recorded: Abemaciclib, Fulvestrant and Placebo. Results have been posted on the registry.
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.
669 enrolled.
95% CI 14.4 to 19.3; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication · 95% CI 7.4 to 11.4
Source95% CI 38.96 to 52.64; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication · 95% CI 34.36 to 43.20
Source95% CI 30.8 to 39.6; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication · 95% CI 11.3 to 21.0
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-Free Survival (PFS)primary | Abemaciclib + Fulvestrant | 446 | 16.4 months | 0.553 (0.449 to 0.681) | <0.0000001 | link |
| Placebo + Fulvestrant | 223 | 9.3 months | ||||
| Overall Survival (OS) | Abemaciclib + Fulvestrant | 446 | 45.8 months | - | - | link |
| Placebo + Fulvestrant | 223 | 37.25 months | ||||
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | Abemaciclib + Fulvestrant | 446 | 35.2% | - | - | link |
| Placebo + Fulvestrant | 223 | 16.1% |
A second publication from the MONARCH 2 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.
This is the paper Europe PMC returns for registry id NCT02107703 with the most citations, so it is the natural first reading for anyone following the MONARCH 2 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.
Shares Abemaciclib, Fulvestrant, Eli Lilly (incl. Loxo), CDK4/6 inhibitors and the tag pipeline.
Shares Abemaciclib, Fulvestrant, CDK4/6 inhibitors, Endocrine therapy (SERMs, AIs, SERDs) and the tag pipeline.
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors, Endocrine therapy (SERMs, AIs, SERDs) and the tag pipeline.
Shares Abemaciclib, CDK4/6 inhibitors, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer and the tag pipeline.
Shares Abemaciclib, Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer and the tag pipeline.
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors and the tag pipeline.
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors and the tag pipeline.
Shares Abemaciclib, Fulvestrant, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer and the tag pipeline.