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

Phase 1

Terminated

Brief Summary: 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

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Panobinostat with trastuzumab	Panobinostat	Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.
Panobinostat with trastuzumab	Trastuzumab	Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicities (DLTs)	day 21	Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Best Overall Response	day 21	Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): \> 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): \> 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.

Locations (8): University of California at Los Angeles
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Los Angeles, California, United States
University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital
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Pittsburgh, Pennsylvania, United States
VA Maryland Health Care Dept.of GreenbaumCancerCent(3)
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Baltimore, Maryland, United States
The Center for Cancer Care and Research
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St. Louis, Missouri, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital SC
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Columbus, Ohio, United States
Norwalk Hospital Dept of Norwalk Hospital (2)
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Norwalk, Connecticut, United States
Novartis Investigative Site
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Manchester, United Kingdom
University of Colorado Dept. of Univ. of Colorado
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Aurora, Colorado, United States