Trials / Completed
CompletedNCT00422903
Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer
Letrozole Versus Letrozole Plus Lapatinib (GW572016) in Hormone-sensitive, HER-2 Negative Operable Breast Cancer. A Double Blind Randomized Phase II Study With Biomarker Evaluation.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lapatinib | 1500 mg administered orally daily |
| DRUG | letrozole | 2.5 mg administered orally daily |
| OTHER | placebo | 1500 mg administered orally daily |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2007-01-17
- Last updated
- 2016-05-12
- Results posted
- 2012-08-29
Locations
14 sites across 2 countries: Italy, Spain
Source: ClinicalTrials.gov record NCT00422903. Inclusion in this directory is not an endorsement.