Status:
COMPLETED
A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Neoplasms
Cancer of the Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval
- Patients with known leptomeningeal carcinomatosis
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00191373
Start Date
March 1 2002
End Date
July 1 2007
Last Update
September 12 2007
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
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.
Hot Springs, Arkansas, United States, 71913
2
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.
Pine Bluff, Arkansas, United States, 71603
3
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.
Redding, California, United States, 96001
4
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.
Hollywood, Florida, United States