A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
Full description
This phase Ib/IIa study was prematurely terminated due to lack of efficacy noted in 55 patients with HER2-positive MBC who had progressed on or following a trastuzumab-based therapy.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key 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
Key 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
56 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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