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Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 26 words Secondary endpoints: details revised at 2 of 3 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Site contact updatedv11
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2025 to Feb 14, 2025 · Site details revisedv10 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2025 to Feb 14, 2025
    • Site details revised
  4. Start date: Dec 2024 to Feb 2025 Primary and study completion dates: Apr 2028 to Jun 2028v9 Show 1 more changeShow less
    • Primary and study completion dates: Apr 2028 to Jun 2028
  5. Start date: Oct 2024 to Dec 2024 Primary and study completion dates: Feb 2028 to Apr 2028 · Site contact updatedv8 Show 2 more changesShow less
    • Primary and study completion dates: Feb 2028 to Apr 2028
    • Site contact updated
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Sep 2024 to Oct 2024v7
  2. Primary and study completion dates: Jan 2028 to Feb 2028 Start date: Aug 2024 to Sep 2024v6 Show 1 more changeShow less
    • Start date: Aug 2024 to Sep 2024
  3. Start date: Jun 2024 to Aug 2024 Primary and study completion dates: Dec 2028 to Jan 2028v5 Show 1 more changeShow less
    • Primary and study completion dates: Dec 2028 to Jan 2028
  4. Start date: May 2024 to Jun 2024v4
  5. Start date: Apr 2024 to May 2024v3
  6. Primary endpoint revised Secondary endpoints revised (3)v2 Show 1 more changeShow less
    • Secondary endpoints revised (3)

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.
Trial Details
NCT Number NCT06105684
Lead Sponsor University of Alabama at Birmingham
Conditions Metastatic Breast Cancer
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov