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A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate in subjects with Breast cancer

Outcome Time Frame:

1 year

Principal Investigator

Helen Eliopoulos, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M02-447

NCT ID:

NCT00063102

Start Date:

November 2002

Completion Date:

August 2004

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Oncology-Hematology Group of South FloridaMiami, Florida  33176
Georgia Cancer SpecialistsDecatur, Georgia  30033
Texas OncologyDallas, Texas  
Clinical Research Network, Inc.Plantation, Florida  33324
Northwestern University Medical School Division of Hematology/OncologyChicago, Illinois  60611
Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer PavilionIndianapolis, Indiana  46202
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Oncology & Hemotology Associates of Kansas City, PAKansas City, Missouri  64111