Status:
COMPLETED
Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
20-74 years
Phase:
PHASE2
Brief Summary
To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen
Eligibility Criteria
Inclusion
- Histologically and/or cytologically confirmed breast cancer
- Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
- To have at least one measurable region
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- To have adequate organ function (bone marrow, liver and renal function)
Exclusion
- To have interstitial pneumonia or pulmonary fibrosis
- To have inflammatory breast cancer
- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
- To have brain metastases with symptoms
- To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00334802
Start Date
June 1 2006
End Date
March 1 2010
Last Update
March 16 2010
Active Locations (15)
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, Japan, 464-8681
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, Japan, 296-8602
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ehime, Japan, 790-0007
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, Japan, 814-0180