Status:
COMPLETED
Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast ...
Eligibility Criteria
Inclusion
- Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
- Unresectable, locally recurrent breast cancer or stage IV disease.
- Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
- Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.
Exclusion
- Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Active infection or other serious condition.
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00316199
Start Date
April 1 2006
End Date
April 1 2008
Last Update
June 17 2009
Active Locations (3)
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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.
Beijing, China, 100071
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.
Guangzhou, China, 510060
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.
Shanghai, China, 200032