deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01307891

Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer

An Open Label, Randomized, Phase II Trial of Abraxane (Paclitaxel Albumin-Bound Particles for Injectable Suspension), With or Without Tigatuzumab (a Humanized Monoclonal Antibody Targeting Death Receptor 5) in Patients With Metastatic, Triple Negative (ER, PR, and HER-2 Negative) Breast Cancer

Sponsor: Daiichi Sankyo UK Ltd.

Conditions Breast Cancer Metastatic Breast Cancer Stage IV Breast Cancer Triple Negative Breast Cancer
Interventions Abraxane + Tigatuzumab Abraxane alone
Updated 8 times since 2017 Last updated: Oct 24, 2017 Started: Mar 31, 2011 Primary completion: Jun 30, 2016 Completion: Jun 30, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01307891, this PHASE2 trial focuses on Breast Cancer and Metastatic Breast Cancer and remains completed. Sponsored by Daiichi Sankyo UK Ltd., it has been updated 8 times since 2011, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Oct 2017 · 8 months · monthly snapshotActive Not Recruiting~Oct 2017 – ~Jun 2018 · 8 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

8 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 3 earlier versions

  1. Oct 2017 — Jun 2018 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Feb 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Mar 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Daiichi Sankyo UK Ltd.
  • Susan G. Komen Breast Cancer Foundation
  • Triple Negative Breast Cancer Foundation
  • University of Alabama at Birmingham
Data source: University of Alabama at Birmingham

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

Study Locations