Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title: A Phase 2 Study of Trastuzumab in Combination With BMS-247550 in Women With Metastatic Breast Cancer

Status Terminated

Clinical Trial Summary

This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone may kill more tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Examine the response rate of HER2-positive metastatic breast cancer to combination therapy with trastuzumab and BMS-247550 in two cohorts of women: a. women who have received no prior chemotherapy or trastuzumab for their metastatic breast cancer; b. women who have received prior trastuzumab therapy (either for metastatic disease or prior adjuvant trastuzumab if < 1 year since completion of adjuvant trastuzumab therapy) and up to 2 prior chemotherapeutic regimens in the metastatic setting.

SECONDARY OBJECTIVES:

I. To characterize the safety and toxicity profile of trastuzumab in combination with BMS-247550.

II. To determine the time-to-disease-progression (TTP) and time-to-treatment-failure (TTF) for patients receiving trastuzumab in combination with BMS-247550 in each cohort.

III. Analyze various tissue biomarkers (e.g. HER2/phospho-HER2, EGFR/phospho-EGFR, IGRF-I, phospho-MAPK, phospho-P13K, bcl-2, bcl-xL, MDR-1, MRP and β-tubulin) and blood biomarkers (HER2-extracellular domain [ECD], circulating tumor cells) to correlate them with response to treatment.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior trastuzumab (Herceptin®) therapy (with or without chemotherapy) for metastatic breast cancer (yes vs no).

Patients receive trastuzumab IV over 30-90 minutes and ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

• NCT number: NCT00079326
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Terminated
• Phase: Phase 2
• Start date: January 2004
• Completion date: October 2010