deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02422615

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. (MONALEESA-3)

A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

Sponsor: Novartis Pharmaceuticals

Conditions Advanced Breast Cancer
Interventions Fulvestrant Placebo Ribociclib
Updated 32 times since 2017 Last updated: Nov 2, 2023 Started: Jun 9, 2015 Primary completion: Nov 3, 2017 Completion: Jan 11, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Advanced Breast Cancer, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 32 data snapshots since 2015. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Oct 2017 · 5 months · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~May 2019 · 3 months · monthly snapshot~May 2019 – ~Jul 2020 · 14 months · monthly snapshot~Jul 2020 – ~Nov 2020 · 4 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 – ~Dec 2021 · 3 months · 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 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Jun 2023 · 3 months · monthly snapshot~Jun 2023 – ~Dec 2023 · 6 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

32 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Dec 2023 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 27 earlier versions

  1. Jun 2023 — Dec 2023 [monthly]

    Completed PHASE3

  2. Mar 2023 — Jun 2023 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

  6. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

  7. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  8. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  9. Jan 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  10. Dec 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  11. Sep 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE3

  12. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  13. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  14. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  15. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  16. Jul 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  17. May 2019 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

  18. Feb 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  19. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  20. Dec 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  21. Nov 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  22. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE3

  23. Jun 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE3

  24. Oct 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  25. May 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE3

  26. Feb 2017 — May 2017 [monthly]

    Active Not Recruiting PHASE3

  27. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Jun 2015

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

A Coruña, Spain , Aalborg, Denmark , Aalst, Belgium , Aarau, Switzerland , Aarhus, Denmark , Albuquerque, United States , Alcorcón, Spain , Amman, Jordan , Amsterdam, Netherlands , Arkhangelsk, Russia and 147 more locations