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Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

NCT00193206 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2021-11-23

Study results available
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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.

Conditions

Interventions

DRUG

Gemcitabine

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

DRUG

Epirubicin

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

DRUG

Albumin-bound Paclitaxel

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

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Denise A. Yardley, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-10-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193206 on ClinicalTrials.gov