At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 142 enrolled
Drug / intervention
Capecitabine +1 moredrug
Likely dose
Capecitabine 1600 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Capecitabine and S-1 for Breast Neoplasms. Completed, enrolled 142 participants across 8 sites.
Detailed Summary
To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2007
Enrollment StartApr 2008
Primary CompletionJul 2012
Study CompletionMay 2013
TodayJul 2026
First PostedFeb 21, 2007
Enrollment StartApr 1, 2008
Primary CompletionJul 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.4 years ago
Interventions
Capecitabinedrug
1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
S-1drug
80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.