A phase Ib/IIa, trial of LBH589 in combination with trastuzumab in adult female patients with HER2 positive metastatic breast cancer whose disease has progressed during or following therapy with trastuzumab

Woman Man

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Extract

• During dose escalation, to determine the MTD of LBH589 that can be combined with trastuzumab, in patients with HER2-positive MBC whose disease has progressed on or after trastuzumab: Arm 1 - Determine the MTD of LBH589 i.v. given on D1, D8 as part of a 21 day cycle, combined with standard doses of trastuzumab in patients with HER2-positive MBC Arm 2 - Determine the MTD of oral LBH589 given twice weekly (e.g. Monday/Thursday) for two consecutive weeks as part of a 21 day cycle, combined with standard doses of trastuzumab in patients with HER2-positive MBC • During expansion of the MTD, to preliminarily explore the anti-tumor activity of i.v. and oral LBH at their respective MTDs when combined with trastuzumab using RECIST criteria

Inclusion criteria

HER positive metastatic breast cancer

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A phase Ib/IIa, trial of LBH589 in combination with trastuzumab in adult female patients with HER2 positive metastatic breast cancer whose disease has progressed during or following therapy with trast...