deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03425656

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer

A Phase III, Randomized, Two-armed, Triple Blinded, Parallel, Active Controlled Non-Inferiority Clinical Trial of AryoTrust (AryoGen Trastuzumab) Efficacy and Safety in Comparison to Herceptin (Genentech) in HER2-Positive Breast Cancer

Sponsor: AryoGen Pharmed Co.

Conditions Malignant Neoplasm of Breast
Interventions Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Updated 8 times since 2018 Last updated: Jan 16, 2024 Started: Jul 9, 2016 Primary completion: Mar 6, 2018 Completion: Aug 5, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Malignant Neoplasm of Breast, this trial is completed. The trial is conducted by AryoGen Pharmed Co. and has accumulated 8 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotRecruiting~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotRecruiting~Mar 2019 – ~Aug 2020 · 17 months · monthly snapshotRecruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 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. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

▶ Show 3 earlier versions

  1. Mar 2019 — Aug 2020 [monthly]

    Recruiting PHASE3

  2. Jun 2018 — Mar 2019 [monthly]

    Recruiting PHASE3

  3. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

    First recorded

Jul 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AryoGen Pharmed Co.
Data source: AryoGen Pharmed Co.

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

Study Locations