deltatrials
Unknown PHASE2 INTERVENTIONAL 1-arm NCT03812393

Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast (FACT-2)

Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

Sponsor: Celcuity Inc

Interventions Neratinib
Updated 10 times since 2019 Last updated: Dec 15, 2023 Started: Jun 21, 2019 Primary completion: Dec 15, 2024 Completion: Dec 15, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03812393, this PHASE2 trial focuses on Early-stage Breast Cancer and HER2-positive Breast Cancer and remains ongoing. Sponsored by Celcuity Inc, it has been updated 10 times since 2019, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Feb 2019 – ~Nov 2019 · 9 months · monthly snapshotNot Yet Recruiting~Nov 2019 – ~Nov 2020 · 12 months · monthly snapshotRecruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotRecruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotRecruiting~Oct 2021 – ~May 2023 · 19 months · monthly snapshotRecruiting~May 2023 – ~Jan 2024 · 8 months · monthly snapshotUnknown Status~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Jan 2026 · 16 months · monthly snapshotActive Not Recruiting~Jan 2026 – present · 8 months · monthly snapshotUnknown

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE2

    Status: Active Not RecruitingUnknown

  2. Sep 2024 — Jan 2026 [monthly]

    Active Not Recruiting PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

  4. Jan 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

    Status: Unknown StatusActive Not Recruiting

  5. May 2023 — Jan 2024 [monthly]

    Unknown Status PHASE2

    Status: RecruitingUnknown Status

Show 5 earlier versions
  1. Oct 2021 — May 2023 [monthly]

    Recruiting PHASE2

  2. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE2

  3. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  4. Nov 2019 — Nov 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  5. Feb 2019 — Nov 2019 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Celcuity Inc
  • Puma Biotechnology, Inc.
  • West Cancer Center
Data source: West Cancer Center

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

Study Locations