A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer


Tracking Information

Start Date  ICMJEDecember 2008
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: November 10, 2008)		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. [ Time Frame: At least 21 day cycle for both arms ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00788931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: November 10, 2008)
  • Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials. [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy in the expansion phase of the trial when the MTD is defined. [ Time Frame: throughout the study and 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
Official Title  ICMJEA Phase Ib, Open-label, Two Arm Study of i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel as Treatment for Adult Female Patients With HER2 Overexpressing Metastatic Breast Cancer (MBC)
Brief Summary

The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer

Detailed Description 
Study PhasePhase I, Phase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment
Condition  ICMJE
  • HER2 Positive
  • Metastatic Breast Cancer
Intervention  ICMJEDrug: panobinostat in combination with trastuzumab and paclitaxel
Study Arms / Comparison Groups
  • IV LBH589 + trastuzumab + paclitaxel: Experimental
    i.v. panobinostat
    Intervention: Drug: panobinostat in combination with trastuzumab and paclitaxel
  • Oral LBH589 + trastuzumab + paclitaxel: Experimental
    oral panobinostat
    Intervention: Drug: panobinostat in combination with trastuzumab and paclitaxel

Recruitment Information

Estimated Enrollment  ICMJE52
Completion Date 
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 year old
  • Confirmed HER2+ ve 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 have had surgery within last 2 weeeks prior to starting the treatment
  • Patients who receive concurent 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
  • Patients not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharmaceuticals+1 800 330 6843
Location Countries  ICMJEAustralia,   Belgium,   Netherlands,   Russian Federation,   Sweden

Administrative Information

NCT ID  ICMJENCT00788931
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECLBH589C2114, EudraCT 2007-004788-23
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsNovartis Pharmaceuticals
Information Provided ByNovartis