A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Study acronym: Next MONARCH 1
StatusCompleted
PhasePhase 2
Started

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Record History

The 50 most recent of 66 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Dec 2026 to Sep 9, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 6 of 9 entries
    • Site details revised at 2 of 59 sites
    • Publications: details revised at 1 of 1 entry
  2. Study completion date: Dec 2025 to Dec 2026v65
  3. 3 versions Re-verified since Jan 23, 2025, no change to tracked fieldsv62-v64
  4. Study completion date: Dec 30, 2024 to Dec 2025v61
  5. Re-verified, no change to tracked fieldsv60
Show 43 earlier versionsHide 43 earlier versions
  1. Study sites: 60 to 59v59
  2. Study sites revised (60)v58
  3. Study completion date: Sep 20, 2023 to Dec 30, 2024v57
  4. Study completion date: Aug 2, 2023 to Sep 20, 2023v56
  5. Study completion date: Aug 2, 2022 to Aug 2, 2023v55
  6. Study completion date: Aug 2, 2021 to Aug 2, 2022v54
  7. Re-verified, no change to tracked fieldsv53
  8. Secondary endpoints: details revised at 2 of 9 entriesv52
  9. Results first posted: Jul 12, 2019v51 Show 5 more changesShow less
    • Enrollment target: estimated 225 to confirmed 234
    • Study completion date: Dec 20, 2019 to Aug 2, 2021
    • Eligibility criteria shortened, about 57 words
    • Secondary endpoints: 7 to 9
    • Site details revised at 2 of 60 sites
  10. Study completion date: May 15, 2019 to Dec 20, 2019v50
  11. 8 versions Re-verified since Sep 11, 2018, no change to tracked fieldsv42-v49
  12. Study completion date: May 2019 to May 15, 2019
    • Start date: Sep 2016 to Sep 14, 2016
    v41
  13. Primary completion date changed from estimate of Jun 2018 to Jun 15, 2018v40
  14. Re-verified, no change to tracked fieldsv39
  15. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 60 of 60 sites
    v38
  16. Primary completion date: Feb 2018 to Jun 2018v37
  17. Study sites: 61 to 60v36
  18. Study sites: 62 to 61v35
  19. Study sites: 63 to 62v34
  20. Site details revised at 23 of 63 sitesv33
  21. Study sites: 64 to 63v32
  22. Study sites: 66 to 64v31
  23. Study sites: 68 to 66v30
  24. Study sites revised (68)v29
  25. Site details revised at 1 of 68 sitesv28
  26. Study sites: 69 to 68v27
  27. Study sites: 70 to 69v26
  28. Study completion date: Aug 2019 to May 2019
    • Site contacts updated at 1 of 70 sites
    v25
  29. Re-verified, no change to tracked fieldsv24
  30. Study sites revised (70)v23
  31. Site details revised at 1 of 70 sitesv22
  32. Site details revised at 1 of 70 sitesv21
  33. Start date: Oct 2016 to Sep 2016v20
  34. Site details revised at 1 of 70 sitesv19
  35. Site details revised at 4 of 70 sitesv18
  36. Site details revised at 8 of 70 sitesv17
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
363 trials monitored
See 16 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
Trial Details
NCT Number NCT02747004
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov