deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03337724

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130)

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

Sponsor: Hoffmann-La Roche

Conditions Breast Cancer
Interventions Ipatasertib Paclitaxel Placebo
Updated 44 times since 2017 Last updated: Feb 15, 2024 Started: Jan 6, 2018 Primary completion: Jan 4, 2023 Completion: Jan 4, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03337724, this PHASE3 trial focuses on Breast Cancer and remains completed. Sponsored by Hoffmann-La Roche, it has been updated 44 times since 2018, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

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

Change History

44 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE3

  5. Mar 2023 — Apr 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

▶ Show 39 earlier versions

  1. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  2. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

  4. Jun 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  5. Feb 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  6. Jan 2022 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  7. Oct 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  8. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Apr 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

    Phase: PHASE2_PHASE3 → PHASE3

  10. Jan 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Recruiting → Active Not Recruiting

  11. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2_PHASE3

  12. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE2_PHASE3

  13. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2_PHASE3

  14. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE2_PHASE3

  15. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE2_PHASE3

  16. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE2_PHASE3

  17. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE2_PHASE3

  18. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE2_PHASE3

  19. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE2_PHASE3

  20. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE2_PHASE3

  21. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE2_PHASE3

  22. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE2_PHASE3

  23. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE2_PHASE3

  24. Oct 2019 — Dec 2019 [monthly]

    Recruiting PHASE2_PHASE3

  25. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE2_PHASE3

  26. Jul 2019 — Sep 2019 [monthly]

    Recruiting PHASE2_PHASE3

  27. May 2019 — Jul 2019 [monthly]

    Recruiting PHASE2_PHASE3

  28. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE2_PHASE3

  29. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE2_PHASE3

  30. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE2_PHASE3

  31. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE2_PHASE3

  32. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE2_PHASE3

    Phase: PHASE3 → PHASE2_PHASE3

  33. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  34. Sep 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

    Phase: PHASE2_PHASE3 → PHASE3

  35. Jul 2018 — Sep 2018 [monthly]

    Recruiting PHASE2_PHASE3

    Phase: PHASE3 → PHASE2_PHASE3

  36. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

    Phase: PHASE2_PHASE3 → PHASE3

  37. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE2_PHASE3

  38. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet Recruiting → Recruiting

  39. Dec 2017 — Mar 2018 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hoffmann-La Roche
Data source: Hoffmann-La Roche

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

Study Locations

?ód?, Poland , Aichi, Japan , Ankara, Turkey (Türkiye) , Arequipa, Peru , Arkhangelsk, Russia , Athens, Greece , Aviano, Italy , Bagno a Ripoli, Italy , Baltimore, United States , Barcelona, Spain and 135 more locations