Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
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Purpose
The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastases |
Drug: larotaxel (RPR109881, XRP9881) Drug: capecitabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Time to tumor progression.
- Overall survival.
| Enrollment: | 438 |
| Study Start Date: | April 2004 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Show 187 Study Locations| Study Director: | ICD CSD | Sanofi |
More Information
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00081796 History of Changes |
| Obsolete Identifiers: | NCT00107406 |
| Other Study ID Numbers: | EFC6089, XRP9881B-3001 |
| Study First Received: | April 20, 2004 |
| Last Updated: | August 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Metastatic Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Capecitabine Fluorouracil |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013