Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT00422903
- Phase
- PHASE2
- Status
- Completed
Conditions
- Neoplasms, Breast
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- lapatinib — DRUG1500 mg administered orally daily
- letrozole — DRUG2.5 mg administered orally daily
- placebo — OTHER1500 mg administered orally daily
Study Details
Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole
Key Dates
- Start date
- Apr 30, 2007
- Status verified
- Mar 2016
- Primary completion
- Apr 30, 2011
- Completion
- Apr 30, 2011
Study Design
- Enrollment
- 92 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Letrozole plus placeboLetrozole 2.5 mg administered orally fro 6 mos. plus placebo 1500 mg administered orally throughout the study until definitive surgery
- Experimental: Letrozole plus lapatininbLetrozole 2.5 mg administered orally fro 6 mos. plus lapatinib 1500 mg administered orally throughout the study until definitive surgery
Primary Outcome Measure
Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee [ Time Frame: From Baseline (Day 1) up to 6 months, evaluated every 12 weeks ]