deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT01698918

Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer (BOLERO-4)

An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer

Sponsor: Novartis Pharmaceuticals

Updated 31 times since 2017 Last updated: Apr 28, 2023 Started: Mar 7, 2013 Primary completion: Dec 17, 2015 Completion: Jan 13, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Hormone Receptor Positive Breast Cancer and is currently completed. Novartis Pharmaceuticals leads this study, which shows 31 recorded versions since 2013 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Jun 2017 · 3 months · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Dec 2017 · 4 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Jan 2019 · 3 months · monthly snapshot~Jan 2019 – ~Jun 2019 · 5 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Mar 2020 · 2 months · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Mar 2022 · 10 months · monthly snapshot~Mar 2022 – ~Jun 2023 · 15 months · monthly snapshot~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

31 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jun 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Mar 2022 — Jun 2023 [monthly]

    Completed PHASE2

Show 26 earlier versions
  1. May 2021 — Mar 2022 [monthly]

    Completed PHASE2

  2. Apr 2021 — May 2021 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  3. Feb 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE2

  5. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  6. Sep 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

  7. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE2

  8. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE2

  9. May 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE2

  10. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE2

  11. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE2

  12. Jan 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE2

  13. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE2

  14. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE2

  15. Aug 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE2

  16. Jun 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE2

  17. Jan 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE2

  18. Oct 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE2

  19. Jun 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE2

  20. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  21. Aug 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  22. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE2

  23. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE2

    Status: Active Not RecruitingRecruiting

  24. Mar 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE2

  25. Feb 2017 — Mar 2017 [monthly]

    Active Not Recruiting PHASE2

  26. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Mar 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 .