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A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.

NCT ID: NCT00063102

Last Updated: 2007-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-08-31

Brief Summary

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The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ABT-751

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage IIIB or IV breast cancer.
* Recurrent tumor after or while on taxane therapy (taxol or taxotere).
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney and liver function.

Exclusion Criteria

* Pregnant or breast feeding.
* No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Helen Eliopoulos, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Oncology-Hematology Group of South Florida

Miami, Florida, United States

Site Status

Clinical Research Network, Inc.

Plantation, Florida, United States

Site Status

Georgia Cancer Specialists

Atlanta, Georgia, United States

Site Status

Northwestern University Medical School Division of Hematology/Oncology

Chicago, Illinois, United States

Site Status

Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer Pavilion

Indianapolis, Indiana, United States

Site Status

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Site Status

Oncology & Hemotology Associates of Kansas City, PA

Kansas City, Missouri, United States

Site Status

Texas Oncology

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M02-447

Identifier Type: -

Identifier Source: org_study_id