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ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer

NCT00110084 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-06-02

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.

Conditions

Interventions

DRUG

Gemcitabine

1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

DRUG

Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Vivek Roy, MD, FACP · Mayo Clinic

  • Philip J. Stella, MD · CCOP - Michigan Cancer Research Consortium

  • Tom R. Fitch, M.D. · Mayo Clinic

  • Timothy J. Hobday, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2010-05-31
Completion
2010-08-31

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 NCT00110084 on ClinicalTrials.gov