Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

StatusCompleted
PhasePhase 1/2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv42
  2. Start date: Feb 25, 2003 to Nov 3, 2003v41
  3. Re-verified, no change to tracked fieldsv40
  4. Primary completion date: Jan 2014 to Jan 6, 2010
    • Study completion date: Jan 2014 to Jan 16, 2014
    • Start date: Feb 2003 to Feb 25, 2003
    • Publications: details revised at 1 of 4 entries
    v39
  5. Publications: details revised at 1 of 4 entriesv38
Show 36 earlier versionsHide 36 earlier versions
  1. Re-verified, no change to tracked fieldsv37
  2. Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Jun 2014 to Jan 2014
    • Study completion date changed from estimate of Dec 2014 to Jan 2014
    v36
  3. Study completion date: Jun 2014 to Dec 2014v35
  4. Re-verified, no change to tracked fieldsv34
  5. Study arms: 0 to 1v33
  6. Study sites revised (5)
    • Eligibility criteria expanded, about 3 words
    • Study description shortened, about 2 words
    v32
  7. Re-verified, no change to tracked fieldsv31
  8. Primary completion date: Dec 2009 to Jun 2014v30 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 93
    • Study completion date: Jun 2014
    • Site details revised at 5 of 5 sites
  9. Lead sponsor: Canadian Cancer Trials Group to NCIC Clinical Trials Group
    • Publications: details revised at 1 of 4 entries
    v29
  10. Study sites: 6 to 5v28
  11. Interventions: docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim (Drug) to docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim (Biological)v27
  12. Re-verified, no change to tracked fieldsv26
  13. Interventions: chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim… to docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim (Drug)v25
  14. Study sites: 4 to 6v24
  15. Primary completion date: Dec 2009v23
  16. Re-verified, no change to tracked fieldsv22
  17. Interventions: biological therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy (Procedure)… to chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim…v21
  18. Start date: Feb 2003
    • Study description expanded, about 23 words
    • Eligibility criteria expanded, about 2 words
    v20
  19. Study sites revised (4)v19
  20. Re-verified, no change to tracked fieldsv18
  21. Primary endpoints: 5 to 2v17
  22. Study Status, Eligibilityv16
  23. Site contacts updated at 1 of 4 sitesv15
  24. Re-verified, no change to tracked fieldsv14
  25. Study Status, Outcome Measuresv13
  26. Study Status, Outcome Measuresv12
  27. Enrollment target: 50
    • Study description expanded, about 26 words
    v11
  28. Study sites revised (4)v10
  29. Re-verified, no change to tracked fieldsv9
  30. Site contacts updated at 1 of 4 sitesv8
  31. Study sites revised (4)v7
  32. Study description expanded, about 54 words
    • Eligibility criteria expanded, about 3 words
    v6
  33. Interventions: biological response modifier therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy… to biological therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy (Procedure)…v5
  34. Interventions: biological response modifier therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy… to biological response modifier therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy…v4
  35. Study sites revised (4)v3
  36. Study sites: 2 to 4v2
  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.
RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.
Trial Details
NCT Number NCT00066443
Lead Sponsor NCIC Clinical Trials Group
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Inflammatory Breast Neoplasms
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov