Status:
COMPLETED
A Phase III Trial For Patients With Metastatic Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 m...
Eligibility Criteria
Inclusion
- Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
- Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
- Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
- Patients must have either measurable or non-measurable (evaluable) disease
- Prior radiation therapy allowed of less than 25% of the bone marrow
Exclusion
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Parenchymal or leptomeningeal brain metastases
- Peripheral neuropathy greater than or equal to grade 2
- Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
- Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
- Concomitant Herceptin is not allowed
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT00191152
Start Date
February 1 2002
End Date
November 1 2008
Last Update
December 24 2009
Active Locations (65)
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.
Glendale, Arizona, United States
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.
Fort Smith, Arkansas, United States
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.
Hot Springs, Arkansas, United States
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Little Rock, Arkansas, United States