A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
NCT ID: NCT00788931
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IV LBH589 + trastuzumab + paclitaxel
i.v. panobinostat
IV LBH589
trastuzumab
paclitaxel
Oral LBH589 + trastuzumab + paclitaxel
oral panobinostat
IV LBH589
Oral LBH589
trastuzumab
paclitaxel
Interventions
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IV LBH589
Oral LBH589
trastuzumab
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Confirmed HER2+ metastatic breast cancer
* Prior treatment and progression on trastuzumab
* Patients must have adequate organ functions
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Exclusion Criteria
* Patients who receive concurrent therapy for brain metastases
* Impaired heart function or clinically significant heart disease
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Mobile, Alabama, United States
Novartis Investigative Site
Woodville, South Australia, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Macerata, MC, Italy
Novartis Investigative Site
Aviano, PN, Italy
Novartis Investigative Site
Amsterdam, , Netherlands
Countries
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Related Links
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Results for LBH589C2114 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2007-004788-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589C2114
Identifier Type: -
Identifier Source: org_study_id