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OpenTrials
Completed

NCT Number: NCT00387907

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

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.

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Key information

Conditions

Advanced Breast Cancer Breast Cancer Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office

Malvern, Pennsylvania, 19355, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Larotaxel (XRP9881)

Drug

administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)

Trastuzumab

Drug

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

Primary outcomes

  1. Tumor response measured

    Time frame: every 2 cycles during treatment phase

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 13, 2006
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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