CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Gemcitabine 1500 mg/m² IV + Carboplatin AUC 2.5 IV on Day 1 of each 14-day cycle (Cycles 1-9); HER2+ patients also receive Trastuzumab 8 mg/kg IV Cycle 1, then 4 mg/kg IV Cycles 2-9, then 6 mg/kg IV Cycles 10+AI-extracted
Key inclusion· 4
  • ✓Histologically or cytologically confirmed metastatic breast cancer
  • ✓Able to attend office visits at least every 14 days during active treatment
  • ✓Able to perform self-care (ECOG ≤2 equivalent)
  • ✓Adequate hematologic and biochemical parameters for therapy
Key exclusion· 5
  • ✕Prior treatment with gemcitabine, carboplatin, or trastuzumab for breast cancer
  • ✕Pregnant or breastfeeding
  • ✕Untreated brain metastases
  • ✕Other active malignancy besides breast cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00191451
NCT00191451Phase 2Completed
CompareCT.gov

Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Nov 20, 2009

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Carboplatin, and 1 other intervention for Breast Cancer. Completed, enrolled 150 participants across 1 site.

Detailed Summary

The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartApr 1, 2004
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)

Carboplatindrug

Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).

Herceptindrug

Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).