Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer
- Determine the response rate in patients with metastatic breast cancer treated with a
fixed-dose of capecitabine.
- Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity
profile of this regimen in these patients.
- Determine the pharmacokinetics (PK) and pharmacogenetics in these patients.
- Correlate pharmacodynamic effects of this drug with toxicity and response in these
- Determine compliance and adherence to this regimen and correlate with PK parameters in
OUTLINE: This is an open-label study.
Patients receive a fixed-dose of oral capecitabine twice daily on days 1-14. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Participants were followed to progression, evaluated every 12 weeks
Antonio C. Wolff, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|DeCesaris Cancer Institute at Anne Arundel Medical Center||Annapolis, Maryland 21401|