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OpenTrials
Completed

NCT Number: NCT00063102

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Oncology-Hematology Group of South Florida, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-751

Drug

Primary outcomes

  1. Objective Response Rate in subjects with Breast cancer

    Time frame: 1 year

Secondary outcomes

  1. Time to Tumor Progression (TTP)

    Time frame: 1 year

  2. Survival

    Time frame: 2 years

  3. Toxicities associated with treatment administration

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Jun 23, 2003
Registry last updated
Nov 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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