Conditions: Neoplasms, Breast
Keywords: neo-adjuvant letrozole lapatinib primary breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 92
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Letrozole 2.5 mg administered orally fro 6 mos. plus placebo 1500 mg administered orally throughout the study until definitive surgery arm 2: Letrozole 2.5 mg administered orally fro 6 mos. plus lapatinib 1500 mg administered orally throughout the study until definitive surgery

Interventions: intervention 1: lapatinib intervention 2: letrozole intervention 3: placebo
Intervention descriptions: intervention 1: 1500 mg administered orally daily intervention 2: 2.5 mg administered orally daily intervention 3: 1500 mg administered orally daily

Protocol document: