Conditions: Breast Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

Brief summary:
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.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.

Secondary

* 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.

Arms:
arm 1: 26 patients received the pre-defined starting dose of capecitabine of 3,000 mg orally daily given in two divided doses. Two thirds of the patients received either the same dose or a 500 mg lower dose compared to what would have been administered with a commonly used body surface area (BSA)-dosing schedule (2,000 mg/m2 with rounding down to nearest 500 mg multiple).

Interventions: intervention 1: capecitabine
Intervention descriptions: intervention 1: A total of 115 cycles of therapy were administered and five patients did not complete cycle 1. The median number of cycles initiated was four (range 1-16).

Protocol document: