deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT03701334

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE)

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Sponsor: Novartis Pharmaceuticals

Conditions Early Breast Cancer
Interventions Endocrine Therapy (ET) Ribociclib
Updated 42 times since 2018 Last updated: Feb 27, 2026 Started: Dec 7, 2018 Primary completion: May 29, 2030 Completion: May 29, 2030
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Early Breast Cancer and is currently ongoing. Novartis Pharmaceuticals leads this study, which shows 42 recorded versions since 2018 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Nov 2018 – ~Feb 2019 · 3 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · 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 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · 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 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 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 – ~Feb 2022 · 3 months · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Feb 2023 · 11 months · monthly snapshot~Feb 2023 – ~Jul 2023 · 5 months · monthly snapshot~Jul 2023 – ~Nov 2023 · 4 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Mar 2026 · 3 months · monthly snapshot~Mar 2026 – present · 6 months · monthly snapshot

Change History

42 versions recorded

  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Dec 2025 — Mar 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Nov 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Sep 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2024 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

▶ Show 37 earlier versions

  1. Nov 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Jul 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE3

  6. Feb 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE3

  7. Mar 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  8. Feb 2022 — Mar 2022 [monthly]

    Active Not Recruiting PHASE3

  9. Nov 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  10. Oct 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE3

  11. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  12. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

    Status: Active Not Recruiting → Recruiting

  13. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  14. Mar 2021 — May 2021 [monthly]

    Recruiting PHASE3

  15. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  16. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  17. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

  18. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  19. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  20. Jun 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  21. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  22. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  23. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  24. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  25. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  26. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  27. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  28. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  29. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  30. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  31. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  32. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  33. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  34. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  35. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  36. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  37. Nov 2018 — Feb 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
  • Translational Research in Oncology
Data source: Novartis

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

Study Locations

A Coruña, Spain , Alicante, Spain , Amiens, France , Ancona, Italy , Angers, France , Ann Arbor, United States , Argenteuil, France , Asheboro, United States , Atlanta, United States , Auchenflower, Australia and 322 more locations