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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387907
• Other study ID #: TCD10037
• Secondary ID: XRP9881
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2006
• Last updated: August 9, 2011
• Start date: October 2006
• Est. completion date: March 2008

Study information

• Verified date: August 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• larotaxel (XRP9881)
IV infusion
• trastuzumab
IV infusion

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Malvern	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response measured		every 2 cycles during treatment phase	No
Secondary	Progression Free Survival and Overall Survival		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	No

External Links

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