deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01735175

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® (PROTECT-1)

A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

Sponsor: Sandoz

Updated 7 times since 2017 Last updated: Jun 29, 2017 Started: Jun 30, 2012 Primary completion: May 31, 2013 Completion: Feb 28, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01735175, this PHASE3 trial focuses on Breast Neoplasms and Chemotherapeutic Toxicity and remains completed. Sponsored by Sandoz, it has been updated 7 times since 2012, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Jul 2017 · 6 months · monthly snapshotCompleted~Jul 2017 – ~Jun 2018 · 11 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 · 12 months · monthly snapshotCompleted

Change History

7 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 2 earlier versions
  1. Jul 2017 — Jun 2018 [monthly]

    Completed PHASE3

  2. Jan 2017 — Jul 2017 [monthly]

    Completed PHASE3

    First recorded

Jun 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sandoz
  • Sandoz GmbH
Data source: Sandoz

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