Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
18 Years
N/A
Female
Metastatic Breast Cancer
Trial Information
Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best Overall Tumor Response
Outcome Time Frame:
baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
China: Food and Drug Administration
Study ID:
9803
NCT ID:
NCT00316199
Start Date:
April 2006
Completion Date:
April 2008
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms
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