Phase III Multicenter Randomized Open-label Study of Irinotecan Plus Capecitabine Versus Capecitabine in Patients Previously Treated With Anthracycline and Taxane for HER2 Negative Metastatic Breast Cancer[PROCEED]
Prior to enrollment, patients will be confirmed for hormone and HER2 receptor status.
Patients may have either measurable and/or evaluable metastatic lesions which are able to be
assessed by chest, abdomen CT and bone scan performed within 28 days prior to start of
- Capecitabine alone arm: 1250 mg/m2, BID, day 1-14, every 3 weeks
- Irinotecan plus capecitabine arm : Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks +
capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks.
Randomization will be done using a random block size permutation method and stratified based
on : hormone receptor status (negative vs. positive), first line vs. more than second lines,
visceral metastasis (negative vs. positive).
Treatment will continue until disease progression, death, or discontinuation due to side
effects of drugs or refusal by patients.
The primary objective of this study is to estimate the PFS of capecitabine and irinotecan in
patients with anthracycline and taxane- pretreated metastatic breast cancer, which will be
estimated by the Kaplan-Meier method and compared by log-rank test. Overall survival will be
also estimated by same method. The secondary statistical analysis consisting of an
estimation of the complete and partial response rates and response rates of the treatment
will be calculated as the ratio of the number of complete and partial responders to the
total number of evaluable patients and toxicity profile, which will be estimated as the
ratio of the number of occurrence to the total number of evaluable patients. A 95%
confidence interval for the response rate is computed based on the binomial distribution
function. The analysis for reporting the final treatment results will be undertaken when
each patient has been potentially followed for a minimum of 12 months. The overall survival
and progression free survival, and their respective medians will be estimated with 95%
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival (PFS)
Day between the date of enrollment to the date of disease progression or death
The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months
National Cencer Center, Korea
South Korea: Institutional Review Board