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

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 ID
NCT06105684
Phase
PHASE2
Sponsor
University of Alabama at Birmingham
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Capecitabine Pill
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249

Key Eligibility Criteria

  • Histologically or cytologically confirmed breast cancer with HER2 negative status. A copy of the pathology report is required at the time of enroll…
  • HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+.
  • Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment.
  • Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).

For full eligibility, visit ClinicalTrials.gov.

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