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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00387907
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : May 5, 2016
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Breast Cancer Breast Cancer Metastatic Breast Cancer Drug: larotaxel (XRP9881) Drug: trastuzumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : October 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Larotaxel + Trastuzumab Drug: larotaxel (XRP9881)
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)

Drug: trastuzumab
administered as a 90-minute IV infusion on Day 1 of every week (qw)

Primary Outcome Measures :
  1. Tumor response measured [ Time Frame: every 2 cycles during treatment phase ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00387907

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

Additional Information:
Responsible Party: Sanofi Identifier: NCT00387907     History of Changes
Other Study ID Numbers: TCD10037
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents