deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT03101748

Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer

A Phase 1b Study of Neratinib, Pertuzumab, and Trastuzumab With Taxol (3HT) in Metastatic and Locally Advanced Breast Cancer, and Phase II Study of 3HT Followed by AC in HER2 + Primary IBC, and Neratinib With Taxol (NT) Followed by AC in HR+ /HER2- Primary IBC

Sponsor: M.D. Anderson Cancer Center

Conditions Breast Inflammatory Carcinoma Locally Advanced Breast Carcinoma Metastatic Breast Carcinoma Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7
Interventions Cyclophosphamide Doxorubicin Laboratory Biomarker Analysis Neratinib Paclitaxel Pertuzumab Trastuzumab
Updated 27 times since 2017 Last updated: Feb 10, 2026 Started: Feb 19, 2018 Primary completion: May 13, 2025 Completion: May 13, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

\<75% accrued

Other terminated trials from M.D. Anderson Cancer Center

See all terminations from M.D. Anderson Cancer Center

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This PHASE1/PHASE2 trial investigates Breast Inflammatory Carcinoma and Locally Advanced Breast Carcinoma and is currently terminated or withdrawn. M.D. Anderson Cancer Center leads this study, which shows 27 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

~May 2017 – ~Feb 2018 · 9 months · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Jan 2019 · 4 months · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Dec 2019 · 4 months · monthly snapshot~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2022 · 13 months · monthly snapshot~May 2022 – ~Sep 2022 · 4 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Jul 2023 · 6 months · monthly snapshot~Jul 2023 – ~Jan 2024 · 6 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Jun 2025 · 5 months · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Feb 2026 · 7 months · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

27 versions recorded

  1. Feb 2026 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Jul 2025 — Feb 2026 [monthly]

    Terminated PHASE1/PHASE2

  3. Jun 2025 — Jul 2025 [monthly]

    Terminated PHASE1/PHASE2

    Status: Active Not Recruiting → Terminated

  4. Jan 2025 — Jun 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

▶ Show 22 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  2. Jan 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Jul 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  4. Jan 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Sep 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  6. May 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  7. Apr 2021 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

  8. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1_PHASE2

  9. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  10. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1_PHASE2

  11. Dec 2019 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  12. Aug 2019 — Dec 2019 [monthly]

    Recruiting PHASE1_PHASE2

  13. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE1_PHASE2

  14. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  15. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  16. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE1_PHASE2

  17. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE1_PHASE2

  18. Sep 2018 — Jan 2019 [monthly]

    Recruiting PHASE1_PHASE2

  19. Jun 2018 — Sep 2018 [monthly]

    Recruiting PHASE1_PHASE2

  20. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  21. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  22. May 2017 — Feb 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

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

Study Locations