At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 41 enrolled
Drug / intervention
Trastuzumab +1 moredrug
Likely dose
Gemcitabine weekly plus trastuzumab (specific dose not stated)AI-extracted
Key inclusion· 7
- ✓HER2-positive metastatic breast cancer confirmed by biopsy
- ✓Measurable disease present
- ✓Able to perform activities of daily living without considerable limitation
- ✓No prior gemcitabine therapy
Key exclusion· 3
- ✕Prior gemcitabine treatment
- ✕History of brain metastases
- ✕Serious underlying medical conditions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Trastuzumab and Gemcitabine for Breast Cancer. Completed, enrolled 41 participants.
Detailed Summary
Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
Countries--
CollaboratorsEli Lilly and Company, Genentech, Inc.
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2001
First PostedSep 2005
Primary CompletionMay 2009
Study CompletionAug 2009
TodayJul 2026
First PostedSep 19, 2005
Enrollment StartJul 1, 2001
Primary CompletionMay 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 20.8 years ago
Interventions
Trastuzumabdrug
Trastuzumab
Gemcitabinedrug
Gemcitabine