deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00615602

Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer

A Multicenter Randomized Phase III Study Comparing 6 Versus 12 Months of Trastuzumab in Combination With Dose Dense Docetaxel Following FE75C as Adjuvant Treatment of Women With Axillary Lymph Node Positive Breast Cancer Over-expressing HER2

Sponsor: Hellenic Oncology Research Group

Conditions Breast Cancer
Interventions 5-fluoruracil Cyclophosphamide Docetaxel Epirubicin Granulocyte-colony stimulating growth factor Trastuzumab
Updated 6 times since 2017 Last updated: Mar 3, 2015 Started: Oct 31, 2004 Primary completion: May 31, 2012 Completion: May 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00615602, this PHASE3 trial focuses on Breast Cancer and remains completed. Sponsored by Hellenic Oncology Research Group, it has been updated 6 times since 2004, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 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 · 11 months · monthly snapshotCompleted

Change History

6 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. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 1 earlier version

  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Oct 2004

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hellenic Oncology Research Group
  • University Hospital of Crete
Data source: Hellenic Oncology Research Group

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

Study Locations