Clinical trial NCT00567879: 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
Official title: A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
HER2 positive
adult-female
LBH589
HDAC inhibitor
panobinostat
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion criteria:

* Age \> 18 year old
* Confirmed HER2+ ve metastatic breast cancer
* Prior treatment and progression on trastuzumab
* Patients must have adequate laboratory values
* Eastern Cooperative Oncology Group (ECOG) performance status of \<2

Key Exclusion criteria:

* Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
* Impaired heart function or clinically significant heart disease
* Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
* 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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: day 21
Secondary outcomes:
measure: Number of Participants With Best Overall Response
timeFrame: day 21
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Aurora
country: United States
facility: University of Colorado Dept. of Univ. of Colorado
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital Dept of Norwalk Hospital (2)
state: Connecticut
city: Baltimore
country: United States
facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(3)
state: Maryland
city: St. Louis
country: United States
facility: The Center for Cancer Care and Research
state: Missouri
city: Columbus
country: United States
facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital
state: Pennsylvania
city: Kelowna
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Dijon Cedex
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Saint-Herblain Cédex
country: France
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Meldola
country: Italy
facility: Novartis Investigative Site
state: FC
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: