At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 92 enrolled
Drug / intervention
lapatinib +2 moredrug
Likely dose
lapatinib 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating lapatinib, letrozole, and 1 other intervention for Neoplasms, Breast. Completed, enrolled 92 participants across 14 sites in 2 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesItaly, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartApr 2007
Primary CompletionApr 2011
TodayJul 2026
First PostedJan 17, 2007
Enrollment StartApr 1, 2007
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 19.5 years ago
Interventions
lapatinibdrug
1500 mg administered orally daily
letrozoledrug
2.5 mg administered orally daily
placeboother
1500 mg administered orally daily