Trials / Completed
CompletedNCT00524303
Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.
Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With ErbB2- (HER2/Neu-) Overexpressing Invasive Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trastuzumab | 4mg/kg IV loading dose followed by 2mg/kg IV weekly |
| DRUG | Paclitaxel | 80mg/m2 IV weekly for 4 (21 day) cycles |
| DRUG | FEC75 | 5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles |
| DRUG | Lapatinib | 1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3 |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2010-10-01
- Completion
- 2015-08-01
- First posted
- 2007-09-03
- Last updated
- 2016-11-11
- Results posted
- 2011-08-11
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00524303. Inclusion in this directory is not an endorsement.