Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00081796|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : August 21, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastases||Drug: larotaxel (RPR109881, XRP9881) Drug: capecitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||438 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
- Time to tumor progression.
- Overall survival.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081796
|Study Director:||ICD CSD||Sanofi|
|Responsible Party:||ICD Study Director, sanofi-aventis|
|Other Study ID Numbers:||
|First Posted:||April 22, 2004 Key Record Dates|
|Last Update Posted:||August 21, 2008|
|Last Verified:||August 2008|
Metastatic Breast Cancer
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action