A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed on or After Trastuzumab

This study is currently recruiting participants.

Verified by Novartis, June 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00567879

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Drug: LBH589/panobinostat	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary 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

Secondary Outcome Measures:

Efficacy throughout the study Safety and tolerability throughout the study Explore potential biomarkers

Estimated Enrollment:	118
Study Start Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

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
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567879

Contacts

Contact: Novartis	862 778 8300
Contact: Novartis Basel	41 61 324 1111

Locations

United States, California
UCLA	Recruiting
Los Angeles, California, United States, 90095
United States, Illinois
	Not yet recruiting
Chicago, Illinois, United States, 60611
United States, New Jersey
	Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Canada
	Not yet recruiting
Toronto, Canada
	Recruiting
Montreal, Canada
France
	Not yet recruiting
Saint Herblain Cedex, France
	Not yet recruiting
Paris, France
	Not yet recruiting
Dijon, France
	Not yet recruiting
Bordeaux, France
Germany
	Not yet recruiting
Heidelberg, Germany
Italy
	Not yet recruiting
Meldola, Italy
	Recruiting
Genova, Italy
	Not yet recruiting
Modena, Italy

Sponsors and Collaborators

Novartis

More Information

Breast Cancer This link exits the ClinicalTrials.gov site

Study ID Numbers:	CLBH589C2204
Study First Received:	December 4, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00567879
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Canada: Health Canada; France: Agence du Medicament; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Breast Cancer
HER2 positive
adult-female

LBH589
HDAC inhibitor
panobinostat

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009