deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00129389

FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients

Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients

Sponsor: Bristol-Myers Squibb

Conditions Breast Cancer
Updated 8 times since 2017 Last updated: Mar 3, 2023 Started: Sep 19, 2003 Primary completion: Oct 1, 2013 Completion: Oct 1, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00129389, this PHASE3 trial focuses on Breast Cancer and remains completed. Sponsored by Bristol-Myers Squibb, it has been updated 8 times since 2003, 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 snapshotUnknown Status~Jun 2018 – ~Aug 2019 · 14 months · monthly snapshotUnknown Status~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2023 · 27 months · monthly snapshotCompleted~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 9 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. Apr 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Apr 2023 [monthly]

    Completed PHASE3

Show 3 earlier versions
  1. Aug 2019 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Unknown StatusCompleted

  2. Jun 2018 — Aug 2019 [monthly]

    Unknown Status PHASE3

  3. Jan 2017 — Jun 2018 [monthly]

    Unknown Status PHASE3

    First recorded

Sep 2003

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bristol-Myers Squibb
  • Spanish Breast Cancer Research Group
Data source: Spanish Breast Cancer Research Group

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