A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab

Inclusion Criteria

Inclusion criteria:

- Age > 18 year old

- Confirmed HER2+ ve metastatic breast cancer

- Prior treatment and progression on trastuzumab

- Patients must have adequate laboratory values

- Eastern Cooperative Oncology Group (ECOG) performance status of <2

Exclusion criteria:

- Patients with active central nervous system (CNS) disease or brain metastases except
those who have been previously treated and have been stable for at least 3 months.

- Impaired heart function or clinically significant heart disease

- Impairment of gastrointestinal (GI) function, or GI disease that may significantly
alter the absorption of LBH589

- Ongoing diarrhea

- Liver or renal disease with impaired hepatic or renal functions

- Concomitant use of any anti-cancer therapy or certain drugs

- Female patients who are pregnant or breast feeding

- Patients not willing to use an effective method of birth control

- Other protocol-defined inclusion/exclusion criteria may apply