Status:
COMPLETED
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen
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 GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer
Eligibility Criteria
Inclusion
- Histologically and/or cytologically confirmed breast cancer
- Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
- To have at least one measurable region
- PS: 0-1
- To have adequate organ function (bone marrow, liver and renal function)
Exclusion
- To have Interstitial pneumonia or pulmonary fibrosis
- To have inflammatory carcinoma
- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
- To have brain metastasis with symptom
- To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00191269
Start Date
June 1 2005
End Date
March 1 2010
Last Update
March 17 2010
Active Locations (13)
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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
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
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
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