Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC

Sponsor
National Cancer Center, Korea
Study ID
NCT00532714
Phase
PHASE2
Status
Completed

Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan plus capecitabine — DRUG
    Irinotecan 80 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period).

Study Details

To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer

Key Dates

Start date
Aug 31, 2006
Status verified
Dec 2011
Primary completion
Apr 30, 2008
Completion
Dec 31, 2011

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: Irinotecan plus capecitabine
    Irinotecan 80 mg/m2 (intravenously once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period) Capecitabine (orally at a dose of 1,000 mg/m2 twice daily 3-week cycles (2 weeks of treatment followed by a 1-week rest period))

Primary Outcome Measure

To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer [ Time Frame: 2009 ]

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