Chemotherapy in Treating Women With Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00004046
• Lead Sponsor: Daiichi Sankyo

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have metastatic breast cancer that has not responded to previous therapy.

Detailed Description

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in women with metastatic adenocarcinoma of the breast who have failed prior therapy with an anthracycline and a taxane. II. Evaluate the quantitative and qualitative toxicities of this drug in these patients. III. Evaluate the pharmacokinetics of this drug in these patients.

OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-06
• Study First Submitted: 2000-05-02
• Primary Completion: 2002-04
• Study Completion: 2002-04
• Study First Submitted QC: 2004-04-14
• Study First Posted: 2004-04-15
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States