`
`Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer Full Text View ClinicalTrials.gov
`
`A service of the U.S. National Institutes of Health
`
`Trial record 7 of 8 for: larotaxel
`Previous Study | Return to List
` | Next Study
`
`Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast
`Cancer
`
`This study has been completed.
`
`Sponsor:
`Sanofi
`
`Information provided by:
`Sanofi
`
`ClinicalTrials.gov Identifier:
`NCT00081796
`
`First received: April 20, 2004
`Last updated: August 20, 2008
`Last verified: August 2008
`History of Changes
`
`Full Text View
`
`Tabular View
`
`No Study Results Posted
`
`Disclaimer
`
`How to Read a Study Record
`
` 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
`
`Breast Cancer
`Metastases
`
`Intervention
`
`Drug: larotaxel (RPR109881, XRP9881)
`Drug: capecitabine
`
`Phase
`
`Phase 3
`
`Interventional
`Study Type:
`Study Design: Allocation: Randomized
`Endpoint Classification: Safety/Efficacy Study
`Intervention Model: Parallel Assignment
`Masking: Open Label
`Primary Purpose: Treatment
`
`Official Title:
`
`A Randomized, OpenLabel, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily
`for 2 Weeks in 3Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: breast cancer
`
`MedlinePlus related topics: Breast Cancer Cancer
`
`Drug Information available for: Capecitabine
`
`U.S. FDA Resources
`
`Further study details as provided by Sanofi:
`
`Primary Outcome Measures:
`Time to tumor progression.
`
`Secondary Outcome Measures:
`Overall survival.
`
`Enrollment:
`Study Start Date:
`
`438
`April 2004
`
`https://clinicaltrials.gov/ct2/show/NCT00081796?term=larotaxel&rank=7
`
`1/3
`
`002004
`
`AVENTIS EXHIBIT 2022
`Mylan v. Aventis, IPR2016-00712
`
`
`
`Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer Full Text View ClinicalTrials.gov
`6/20/2016
`Study Completion Date:
`September 2006
`Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
`
`Detailed Description:
`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
`
`18 Years and older
`Ages Eligible for Study:
`Both
`Genders Eligible for Study:
`Accepts Healthy Volunteers: No
`
`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).
`
` Contacts and Locations
`
`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, see Learn About Clinical Studies.
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT00081796
`
` Show 187 Study Locations
`
`Sponsors and Collaborators
`Sanofi
`
`Investigators
`Study Director:
`
`ICD CSD Sanofi
`
` More Information
`
`ICD Study Director, sanofiaventis
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT00081796 History of Changes
`Obsolete Identifiers:
`NCT00107406
`EFC6089 XRP9881B3001
`Other Study ID Numbers:
`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
`Breast Diseases
`Neoplasms
`Neoplasms by Site
`Skin Diseases
`
`Capecitabine
`Antimetabolites
`Antimetabolites, Antineoplastic
`Antineoplastic Agents
`Molecular Mechanisms of Pharmacological Action
`
`https://clinicaltrials.gov/ct2/show/NCT00081796?term=larotaxel&rank=7
`
`2/3
`
`
`
`6/20/2016
`
`Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer Full Text View ClinicalTrials.gov
`
`ClinicalTrials.gov processed this record on June 19, 2016
`
`https://clinicaltrials.gov/ct2/show/NCT00081796?term=larotaxel&rank=7
`
`3/3