At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 62 enrolled
Drug / intervention
gemcitabine +1 moredrug
Likely dose
gemcitabine 1000 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.
Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline
In Brief
A Phase 2 clinical trial evaluating gemcitabine and paclitaxel for Metastatic Breast Cancer. Completed, enrolled 62 participants across 15 sites.
Detailed Summary
To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedJun 2006
Primary CompletionFeb 2008
Study CompletionMar 2010
TodayJul 2026
First PostedJun 8, 2006
Enrollment StartJun 1, 2006
Primary CompletionFeb 1, 2008
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.1 years ago
Interventions
gemcitabinedrug
Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation) Phase 2: dose determined by phase 1
paclitaxeldrug
Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles