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PhII ICb With/Without Erbitux in MBC Pts

Study acronym: CA225200
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 29, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 2024 to Dec 2025 Completion date: Dec 2025 to Dec 2026v18 Show all 2 changesShow less
    • Completion date: Dec 2025 to Dec 2026
  2. Completion date: Dec 2024 to Dec 2025v17
  3. Primary and study completion dates: Dec 2022 to Dec 2024v16
  4. Primary completion date: May 31, 2014 to Dec 2022 Completion date: Dec 31, 2020 to Dec 2022v15 Show all 2 changesShow less
    • Completion date: Dec 31, 2020 to Dec 2022
  5. Completion date: Dec 31, 2019 to Dec 31, 2020v14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary completion date: May 2014 to May 31, 2014 Completion date: Dec 2016 to Dec 31, 2019 · Start date: Jul 2005 to Jul 28, 2005v13 Show all 3 changesShow less
    • Completion date: Dec 2016 to Dec 31, 2019
    • Start date: Jul 2005 to Jul 28, 2005
  2. Results first posted: Nov 3, 2016 Primary endpoint revised · Primary completion date changed from estimate of Jun 2014 to May 2014 · Completion date: Dec 2014 to Dec 2016 · 1 morev12 Show all 5 changesShow less
    • Primary endpoint revised
    • Primary completion date changed from estimate of Jun 2014 to May 2014
    • Completion date: Dec 2014 to Dec 2016
    • Secondary endpoints expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jun 2013 to Jun 2014 Completion date: Dec 2014v11 Show all 2 changesShow less
    • Completion date: Dec 2014
  4. Primary completion date: Jun 2013 Interventions: Carboplatin (Drug), Erbitux (Drug), Irinotecan (Drug) to Irinotecan + Carboplatin (Drug), irinotecan + Carboplatin + erbitux (Drug) · Study arms: 0 to 2v10 Show all 3 changesShow less
    • Interventions: Carboplatin (Drug), Erbitux (Drug), Irinotecan (Drug) to Irinotecan + Carboplatin (Drug), irinotecan + Carboplatin + erbitux (Drug)
    • Study arms: 0 to 2
  5. Trial status: Recruiting to Active, Not Recruiting Site details revised at 59 of 59 sites · Eligibility criteria expanded, about 1 wordv9 Show all 3 changesShow less
    • Site details revised at 59 of 59 sites
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites revised (59) Eligibility criteria shortened, about 1 wordv8 Show all 2 changesShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  7. Enrollment target: 120 to 154 Study sites: 64 to 59 · Eligibility criteria expanded, about 156 wordsv7 Show all 3 changesShow less
    • Study sites: 64 to 59
    • Eligibility criteria expanded, about 156 words

    See this version in full on ClinicalTrials.gov ↗

  8. Site contacts updated at 64 of 64 sitesv6
  9. Site contacts updated at 1 of 64 sitesv5
  10. Study sites: 63 to 64v4
  11. Re-verified, no change to tracked fieldsv3
  12. Study sites revised (63)v2 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.
Trial Details
NCT Number NCT00248287
Lead Sponsor US Oncology Research
Collaborators: Bristol-Myers Squibb, Pfizer
Conditions Metastatic Breast Cancer
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov