CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Gemcitabine 2000 mg/m² IV day 1 every 14 days × 6 cycles; Epirubicin 50 mg/m² day 1 every 14 days × 6 cycles; ABI-007 (nab-paclitaxel) 175 mg/m² day 1 every 14 days × 6 cyclesAI-extracted
Key inclusion· 8
  • ✓Locally advanced or inflammatory adenocarcinoma of the breast
  • ✓Age 18 years or older
  • ✓Normal heart function
  • ✓Able to perform activities of daily living with minimal assistance
Key exclusion· 5
  • ✕Pregnant or breast feeding
  • ✕History of congestive heart failure
  • ✕Myocardial infarction within the previous 6 months
  • ✕Prior chemotherapy or hormone therapy for breast cancer

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

Search/NCT00193206
NCT00193206Phase 2Completed
CompareCT.gov

Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Nov 23, 2021

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Epirubicin, and 1 other intervention for Breast Cancer. Completed, enrolled 123 participants across 13 sites.

Detailed Summary

In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsEli Lilly and Company, Celgene Corporation

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartSep 1, 2005
Primary CompletionOct 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles

Epirubicindrug

Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles

Albumin-bound Paclitaxeldrug

ABI-007 175 mg/m2 D1 q 14 days x 6 cycles