The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Novartis Investigative Site
Mobile, Alabama, United States
Novartis Investigative Site
Woodville, South Australia, Australia
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Liège, Belgium
Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel.
Time frame: At least 21 day cycle for both arms
Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.
Time frame: 4 weeks after end of treatment
To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.
Time frame: throughout the study and 4 weeks after end of treatment
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Novartis Investigative Site
Macerata, MC, Italy
Novartis Investigative Site
Aviano, PN, Italy
Novartis Investigative Site
Amsterdam, Netherlands