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

NCT00532714 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-12-30

No results posted yet for this study

Summary

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

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Irinotecan plus capecitabine

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).

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Jungsil Ro, M.D. · National Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-04-30
Completion
2011-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00532714 on ClinicalTrials.gov