PhII ICb With/Without Erbitux in MBC Pts

Study acronym: CA225200
StatusActive, Not Recruiting
PhasePhase 2
Started

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.

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Record History

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  1. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Dec 2025 to Dec 2026
    v18
  2. Study completion date: Dec 2024 to Dec 2025v17
  3. Primary and study completion dates: Dec 2022 to Dec 2024v16
  4. Primary and study completion dates pushed to Dec 2022v15
  5. Study 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
    • Study completion date: Dec 2016 to Dec 31, 2019
    • Start date: Jul 2005 to Jul 28, 2005
    v13
  2. Results first posted: Nov 3, 2016v12 Show 4 more changesShow less
    • Primary endpoint revised
    • Primary completion date changed from estimate of Jun 2014 to May 2014
    • Study completion date: Dec 2014 to Dec 2016
    • Secondary endpoints expanded, about 13 words
  3. Primary completion date: Jun 2013 to Jun 2014
    • Study completion date: Dec 2014
    v11
  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 2
    v10
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 59 of 59 sites
    • Eligibility criteria expanded, about 1 word
    v9
  6. Study sites revised (59)
    • Eligibility criteria shortened, about 1 word
    v8
  7. Enrollment target: 120 to 154
    • Study sites: 64 to 59
    • Eligibility criteria expanded, about 156 words
    v7
  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
  1. Study First Submitted
  • 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
(from sponsor)		 Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov