A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
Phase 1
Completed
- Conditions
- HER-2 Positive Breast CancerMetastatic Breast Cancer
- Interventions
- Registration Number
- NCT00788931
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
- Age > 18 year old
- 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 have had surgery within last 2 weeks prior to starting the treatment
- 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
- Patients not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IV LBH589 + trastuzumab + paclitaxel IV LBH589 i.v. panobinostat Oral LBH589 + trastuzumab + paclitaxel IV LBH589 oral panobinostat Oral LBH589 + trastuzumab + paclitaxel Oral LBH589 oral panobinostat IV LBH589 + trastuzumab + paclitaxel trastuzumab i.v. panobinostat IV LBH589 + trastuzumab + paclitaxel paclitaxel i.v. panobinostat Oral LBH589 + trastuzumab + paclitaxel trastuzumab oral panobinostat Oral LBH589 + trastuzumab + paclitaxel paclitaxel oral panobinostat
- Primary Outcome Measures
Name Time Method 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. At least 21 day cycle for both arms
- Secondary Outcome Measures
Name Time Method Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials. 4 weeks after end of treatment To evaluate the efficacy in the expansion phase of the trial when the MTD is defined. throughout the study and 4 weeks after end of treatment
Trial Locations
- Locations (1)
Novartis Investigative Site
🇳🇱Amsterdam, Netherlands