A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease

Phase 2

Completed

• Conditions: Breast Neoplasms; Cancer of the Breast; Breast Cancer

• Registration Number: NCT00191373
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion administered on subsequent cycles.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2007-07
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-11
• Last Update Posted: 2007-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease
• Tumors tested by IHC must be 3+ positive for HER2 overexpression. Tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER2. Tumors that are 3+ by IHC but negative by FISH assay are ineligible
• Patients must have measurable disease
• Patients may NOT have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer.
• Patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer, including taxane-based chemotherapy regimens. Patients may NOT have received trastuzumab in the adjuvant setting unless disease free interval from completion of trastuzumab to time of relapse is greater than 12 months.

Exclusion Criteria

• Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval
• Patients with known leptomeningeal carcinomatosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
- Overall response rates

Secondary Outcome Measures

Name	Time	Method
Time to disease progression,Time to treatment failure, Overall survival, Toxicity of the combination

Trial Locations

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Ogden, Utah, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Morgantown, West Virginia, United States