Tipifarnib Plus Trastuzumab in Treating Patients With Metastatic Breast Cancer

Phase 2

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT00054470
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining tipifarnib with trastuzumab may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with trastuzumab in treating patients who have metastatic breast cancer.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of tipifarnib and trastuzumab (Herceptin) in patients with metastatic breast cancer.

* Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral tipifarnib twice daily on days 1-21 and trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 18-40 patients will be accrued for this study within 9-20 months.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-01
• Study Completion: 2003-01
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP