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Home > "A" Clinical Trials Conditions > An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer  An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer
An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer
For Condition: Metastatic breast cancer
Status: Recruiting
Sponsor(s): Aventis Pharmaceuticals ,
Synopsis: The purpose of this clinical trial is to determine if the investigational drug is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel
Details: All patients in this trial will receive either the investigational drug or capecitabine, a chemotherapy drug that is already approved to treat your disease. These drugs prevent tumor cells from dividing, so they may stop growing or die. The investigational drug in this clinical trial is a chemotherapy drug given through the vein once every three weeks. Patients who receive capecitabine will receive this drug by mouth for 14 days, every 21 days.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Eligibility Criteria In order to be eligible for this trial you must: - have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery. - have received previous treatment with anthracyclines (e.g., adriamycin, Doxorubicin) and taxanes (e.g., paclitaxel, docetaxel, Taxol®, Taxotere®) for your breast cancer and your doctor has determined that these treatment are no longer of benefit to you. - be at least 18 years of age. - not be taking other treatments for your cancer at the time you enter this trial. - not be pregnant. Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (e.g., lab tests, CT scans).
Total Enrollment: 800
Location and Contact Information:
Aventis Pharmaceutical Inc (Trial Sponsor for multinational study) *Recruiting*
Bridgewater, New Jersey, 08807
United States
Recruiting
Additional Information:
Study ID Numbers: XRP9881B/3001;
Study Start Date: April 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081796
Other Metastatic Breast Cancer Studies:
1. Capecitabine (Xeloda) With Or Without GW572016 For Women With Refractory Advanced Or Metastatic Breast Cancer
2. Novel Epothilone (BMS-247550) in Patients with Metastatic Breast Cancer (MBC)
3. An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer
4. Paclitaxel With Or Without GW572016 As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
5. Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer
Related Studies:
Other Metastatic breast cancer Clinical Trials
Other New Jersey Clinical Trials
Other Bridgewater Clinical Trials
An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer
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