deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01958021

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer (MONALEESA-2)

A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Sponsor: Novartis Pharmaceuticals

Conditions Advanced, Metastatic Breast Cancer
Interventions Letrozole Placebo Ribociclib
Updated 43 times since 2017 Last updated: Feb 25, 2025 Started: Dec 17, 2013 Primary completion: Jan 29, 2016 Completion: Mar 16, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01958021, this PHASE3 trial focuses on Advanced, Metastatic Breast Cancer and remains completed. Sponsored by Novartis Pharmaceuticals, it has been updated 43 times since 2013, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~May 2019 · 5 months · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Jun 2022 · 5 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Jan 2023 · 2 months · monthly snapshot~Jan 2023 – ~Apr 2023 · 3 months · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jul 2024 · 14 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

43 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Apr 2025 — Sep 2025 [monthly]

    Completed PHASE3

  4. Sep 2024 — Apr 2025 [monthly]

    Completed PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

▶ Show 38 earlier versions

  1. May 2023 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Apr 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE3

  3. Jan 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

  6. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  7. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  8. Jan 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  9. Dec 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  10. Nov 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE3

  11. Oct 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE3

  12. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

  13. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  14. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  15. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  16. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  17. Sep 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  18. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE3

  19. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

  20. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

  21. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

  22. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE3

  23. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE3

  24. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE3

  25. Dec 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

  26. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  27. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  28. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  29. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  30. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  31. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE3

  32. Dec 2018 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  33. Sep 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  34. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  35. Jun 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE3

  36. Jul 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  37. Feb 2017 — Jul 2017 [monthly]

    Active Not Recruiting PHASE3

  38. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Dec 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarhus, Denmark , Alkmaar, Netherlands , Allentown, United States , Angers, France , Ankara, Turkey (Türkiye) , Arkhangelsk, Russia , Aschaffenburg, Germany , Aurora, United States , Aviano, Italy , Avignon, France and 190 more locations