deltatrials
Completed PHASE2 INTERVENTIONAL 4-arm NCT01494662

HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

A Phase II Trial of HKI-272 (Neratinib), Neratinib and Capecitabine, and Ado-Trastuzumab Emtansine for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases

Sponsor: Dana-Farber Cancer Institute

Conditions Breast Cancer
Interventions Ado-Trastuzumab Emtansine Capecitabine HKI-272 Surgical Resection
Updated 31 times since 2017 Last updated: Jan 21, 2026 Started: Feb 29, 2012 Primary completion: Feb 1, 2023 Completion: Apr 19, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01494662, this PHASE2 trial focuses on Breast Cancer and remains completed. Sponsored by Dana-Farber Cancer Institute, it has been updated 31 times since 2012, 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 – ~Feb 2018 · 7 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Dec 2019 · 3 months · monthly snapshot~Dec 2019 – ~Jun 2020 · 6 months · monthly snapshot~Jun 2020 – ~Dec 2020 · 6 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Oct 2021 · 4 months · monthly snapshot~Oct 2021 – ~Jan 2022 · 3 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Mar 2023 · 9 months · monthly snapshot~Mar 2023 – ~Aug 2023 · 5 months · monthly snapshot~Aug 2023 – ~Nov 2023 · 3 months · monthly snapshot~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · 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

31 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Sep 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE2

  3. Apr 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2024 — Apr 2025 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

▶ Show 26 earlier versions

  1. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Nov 2023 — Jun 2024 [monthly]

    Active Not Recruiting PHASE2

  3. Aug 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE2

  4. Mar 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

  5. Jun 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2

  6. Apr 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  7. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE2

  8. Jan 2022 — Mar 2022 [monthly]

    Recruiting PHASE2

  9. Oct 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  10. Jun 2021 — Oct 2021 [monthly]

    Recruiting PHASE2

  11. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  12. Jan 2021 — May 2021 [monthly]

    Recruiting PHASE2

  13. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  14. Jun 2020 — Dec 2020 [monthly]

    Recruiting PHASE2

  15. Dec 2019 — Jun 2020 [monthly]

    Recruiting PHASE2

  16. Sep 2019 — Dec 2019 [monthly]

    Recruiting PHASE2

  17. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE2

  18. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE2

  19. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

  20. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE2

  21. Dec 2018 — Mar 2019 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

  22. Jun 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE2

  23. Feb 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  24. Jul 2017 — Feb 2018 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  25. Feb 2017 — Jul 2017 [monthly]

    Recruiting PHASE2

  26. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Feb 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Dana-Farber Cancer Institute
  • Puma Biotechnology, Inc.
  • Translational Breast Cancer Research Consortium
Data source: Dana-Farber Cancer Institute

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

Study Locations

Ann Arbor, United States , Baltimore, United States , Boston, United States , Chapel Hill, United States , Cranberry Township, United States , Durham, United States , Greensburg, United States , Harrisburg, United States , Houston, United States , Mechanicsburg, United States and 4 more locations