Capecitabine in Treating Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00274768|
Recruitment Status : Completed
First Posted : January 11, 2006
Results First Posted : December 21, 2012
Last Update Posted : October 14, 2015
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: capecitabine||Phase 2|
- 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 patients.
- Determine compliance and adherence to this regimen and correlate with PK parameters in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||November 2012|
- Response Rate [ Time Frame: Participants were followed to progression, evaluated every 12 weeks ]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.
- Clinical Benefit, Time to Treatment Failure, Safety and Toxicity [ Time Frame: Time to progression ]
- Pharmacokinetic and Pharmacodynamic Effects [ Time Frame: Time to progression ]
- Adherence and Compliance to Oral Medication Using Electronic Monitoring [ Time Frame: Every 3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274768
|United States, Maryland|
|DeCesaris Cancer Institute at Anne Arundel Medical Center|
|Annapolis, Maryland, United States, 21401|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Antonio C. Wolff, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|