Conditions: Breast Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 29
Healthy volunteers: no

Brief summary:
An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.

Detailed description:

Arms:
arm 1: BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE) arm 2: Lapatinib tablets 1500 mg daily. arm 3: Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.

Interventions: intervention 1: lapatinib intervention 2: BIBW 2992 intervention 3: trastuzumab
Intervention descriptions: intervention 1: lapatinib tablets 1500 mg daily intervention 2: BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE) intervention 3: trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly

Protocol document: