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Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00387907
First received: October 12, 2006
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.


Condition Intervention Phase
Advanced Breast Cancer
Breast Cancer
Metastatic Breast Cancer
Drug: larotaxel (XRP9881)
Drug: trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Tumor response measured [ Time Frame: every 2 cycles during treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival and Overall Survival [ Time Frame: measured every 3 weeks during study treatment, then every 6 weeks after a patient has stopped the study treatment until the patient's cancer worsens, then every 3 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: larotaxel (XRP9881)
    IV infusion
    Drug: trastuzumab
    IV infusion
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of breast cancer
  • Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery
  • No more than one prior treatment for advanced disease
  • Her2 positive status
  • Adequate liver and kidney function
  • No remaining severe harmful effects to prior treatments

Exclusion Criteria:

  • Certain heart condition
  • Pregnant Women
  • History of another cancer except some skin cancers and cervical cancer
  • Taking other treatments for your cancer at the time you enter the trial
  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: NCT00387907

Locations
United States, Pennsylvania
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States, 19355
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Eric Winer, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00387907     History of Changes
Other Study ID Numbers: TCD10037, XRP9881
Study First Received: October 12, 2006
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Herceptin
Taxane
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014