Trials / Completed
CompletedNCT00387907
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2006-10-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2006-10-13
- Last updated
- 2016-05-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00387907. Inclusion in this directory is not an endorsement.