Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer

Sponsor
National Cancer Center, Korea
Study ID
NCT01501669
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan, Capecitabine — DRUG
    Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks \+ capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks

Study Details

This study is a multicenter, randomized study, open-label, phase III study.The efficacy of irinotecan and capecitabine combination will be superior to capecitabine alone in term of progression free survival in metastatic breast cancer patients previously treated with anthracycline and taxane.

Key Dates

Start date
Jun 30, 2011
Status verified
Jul 2012
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Capecitabine alone arm
    X arm
  • Experimental: Irinotecan plus capecitabine arm

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months ]

Central Contacts

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