Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents
- Conditions
- Breast Neoplasms
- Registration Number
- NCT00191438
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- Locally advanced and/or metastatic breast cancer.
- Measurable disease
- Previously treated with anthracycline
- Patients with inflammatory breast disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Progression free survival. The final analysis will occur when 250 patients have progressed or died.
- Secondary Outcome Measures
Name Time Method Time to Treatment Failure Overall toxicity Quality of Life Overall Survival Overall Response Rate
Related Research Topics
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Trial Locations
- Locations (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 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧Nottingham City, Nottinghamshire, United Kingdom