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8 studies found for:    lbh-589 breast

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1 Completed A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
Conditions: HER-2 Positive Breast Cancer;   Metastatic Breast Cancer
Interventions: Drug: IV LBH589;   Drug: Oral LBH589;   Drug: trastuzumab;   Drug: paclitaxel
Study Type: Interventional
Phase: Phase 1
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel.;   Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.;   To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.
Study Start: December 2008
Study Completion:
2 Active, not recruiting LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients
Condition: Breast Cancer
Interventions: Drug: LBH589;   Drug: Capecitabine;   Drug: Lapatinib
Study Type: Interventional
Phase: Phase 1
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: To determine the maximum tolerated doses (MTD) and dose-limiting toxicities (DLT) of LBH589 in combination with capecitabine when administered to patients with refractory and advanced tumor types that are sensitive to 5-fluorouracil;   To evaluate the antitumor activity of LBH589 in combination with capecitabine in patients with refractory and advanced tumors;   To evaluate the tolerability and preliminary efficacy of established doses of LBH589 and capecitabine with lapatinib in a limited number of patients with HER2+ breast cancer
Study Start: May 2008
Study Completion: June 2013
3 Recruiting Re-expression of ER in Triple Negative Breast Cancers
Conditions: Breast Cancer;   Breast Tumors;   Breast Neoplasms
Intervention: Drug: Decitabine, LHB589, Tamoxifen
Study Type: Interventional
Phases: Phase 1 / Phase 2
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: To determine the maximum tolerated dose of decitabine and LBH589 given in combination in patients with metastatic or locally advanced metastatic breast cancers;   To determine the safety of tamoxifen in combination with decitabine and LBH589
Study Start: July 2010
Study Completion: July 2016
4 Completed A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed on or After Trastuzumab
Condition: Breast Cancer
Intervention: Drug: panobinostat, trastuzumab
Study Type: Interventional
Phase: Phase 1
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Determine the dose of oral panobinostat plus trastuzumab combination;   Determine the dose of iv LBH plus trastuzumab combination;   Explore preliminary anti-tumor activity of the combination;   Efficacy;   Safety and tolerability;   Explore potential biomarkers
Study Start: April 2008
Study Completion: May 2011
5 Recruiting Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
Interventions: Drug: letrozole;   Drug: panobinostat;   Genetic: RNA analysis;   Genetic: microarray analysis;   Genetic: reverse transcriptase-polymerase chain reaction;   Other: enzyme-linked immunosorbent assay;   Other: immunohistochemistry staining method;   Other: laboratory biomarker analysis
Study Type: Interventional
Phases: Phase 1 / Phase 2
Study Design: Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Maximum-tolerated dose (phase I);   Adverse events;   Response rate (phase II);   Survival time (phase II);   Time-to-disease progression (phase II);   Progression-free survival (phase II);   Duration of response (phase II)
Study Start: September 2010
Study Completion:
6 Terminated
Has Results 		Study of Panobinostat Monotherapy in Women With v-ERB-B2 Avian Erythroblastic Leukemia Viral Oncogene Homolog 2 (HER2) Positive Locally Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
Intervention: Drug: Panobinostat - LBH589
Study Type: Interventional
Phase: Phase 2
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Overall Response (OR) Rate (as Determined by the Investigator): the Number of Patients Assigned to a Treatment Arm With a Confirmed Best Response of Complete Response(CR) or Partial Response (PR).;   Corrected QT Interval Fridericia's Formula (QTcF)
Study Start: February 2009
Study Completion: March 2010
7 Active, not recruiting Study of Panobinostat Monotherapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
Intervention: Drug: Panobinostat - LBH589
Study Type: Interventional
Phase: Phase 2
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measure: Objective Response Rate (as determined by investigator): the percentage of patients assigned to a treatment arm with a confirmed best response of CR or PR.
Study Start: February 2009
Study Completion: November 2012
8 Terminated ERB-B4 After Treatment With HDAC Inhibitor in ER+ Tamoxifen Refractory Breast Cancer
Condition: Breast Cancer
Intervention: Drug: Panobinostat (LBH589)
Study Type: Interventional
Phase: Phase 0
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Outcome Measure: The primary objective of the study is to compare the expression level of ERBB4 pre- and post- treatment with HDACi, Panobinostat (LBH589).
Study Start: September 2009
Study Completion: December 2010
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† Indicates status has not been verified in more than two years