Trials / Unknown
UnknownNCT00842998
Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer
A Phase II, Randomized Trial With Single Agent Trastuzumab or Lapatinib in Patients With Metastatic HER2-Overexpressing Breast Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Azienda Ospedaliera Ordine Mauriziano di Torino · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the activity of single agent trastuzumab or lapatinib in patients not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A companion biological study will assess factors correlated with sensitivity or resistance to either one of the compounds
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trastuzumab or Lapatinib | Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2009-02-12
- Last updated
- 2009-06-26
Locations
4 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00842998. Inclusion in this directory is not an endorsement.