Trials / Completed
CompletedNCT01423695
Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- WiSP Wissenschaftlicher Service Pharma GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | paclitaxel plus trastuzumab | Weekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression) |
Timeline
- Start date
- 2001-02-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2011-08-26
- Last updated
- 2011-08-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01423695. Inclusion in this directory is not an endorsement.