Study of Panobinostat Monotherapy in Women With HER2-negative Locally Recurrent or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00777049

Recruitment Status : Completed

First Posted : October 22, 2008

Results First Posted : July 15, 2016

Last Update Posted : July 15, 2016

Sponsor:

Information provided by (Responsible Party):

Translational Research in Oncology

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Breast Cancer
Intervention	Drug: Panobinostat
Enrollment	54

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	ER+ and/or PgR+ (Arm I)	ER- and PgR- (Arm II)
Arm/Group Description	Panobinostat - LBH589: hard gelatin...	Panobinostat - LBH589: hard gelatin...
Arm/Group Description	Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
Period Title: Overall Study
Started	33	21
Completed	32	20
Not Completed	1	1
Reason Not Completed
Withdrawal by Subject	1	0
No treatment (elevated liver enzymes)	0	1

Baseline Characteristics

Arm/Group Title		ER+ and/or PgR+ (Arm I)	ER- and PgR- (Arm II)	Total
Arm/Group Description		Panobinostat - LBH589: hard gelatin...	Panobinostat - LBH589: hard gelatin...	Total of all reporting groups
Arm/Group Description		Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	Total of all reporting groups
Overall Number of Baseline Participants		33	21	54
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	33 participants	21 participants	54 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	22 66.7%	18 85.7%	40 74.1%
	>=65 years	11 33.3%	3 14.3%	14 25.9%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	33 participants	21 participants	54 participants
		60.3 (9.5)	52.8 (10.7)	57.4 (10.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	33 participants	21 participants	54 participants
	Female	33 100.0%	21 100.0%	54 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	33 participants	21 participants	54 participants
Race - White		31	20	51
Race - Black or African American		1	0	1
Race - Asian		1	1	2
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	33 participants	21 participants	54 participants
United States		11	10	21
Belgium		1	0	1
Canada		4	6	10
France		5	1	6
Ireland		10	1	11
United Kingdom		2	3	5
Ethnicity Measure Type: Number Unit of measure: Participants	Number Analyzed	33 participants	21 participants	54 participants
Hispanic or Latino		2	3	5
Not Hispanic or Latino		31	18	49
Menopausal Status Measure Type: Number Unit of measure: Participants	Number Analyzed	33 participants	21 participants	54 participants
Premenopausal		0	5	5
Postmenopausal		33	16	49

Outcome Measures

1.Primary Outcome


Title	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.
Description	The assessment of overall response (OR) is based on the response of ta...
Description	The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).
Time Frame	6 years and 2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	ER+ and/or PgR+ (Arm I)	ER- and PgR- (Arm II)
Arm/Group Description:	Panobinostat - LBH589: hard gelatin...	Panobinostat - LBH589: hard gelatin...
Arm/Group Description:	Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
Overall Number of Participants Analyzed	33	21
Measure Type: Number Unit of Measure: participants
Complete Response	0	1
Partial Response	1	0
Stable Disease / Incompete Response	13	4
Progressive Disease	14	14
Missing	5	2

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Patients were regularly evaluated for AEs at each study visit, and carefully monitored during the entire treatment phase. Safety evaluations consisted of medical interviews, recording of AEs as reported by the patient, physical examinations, blood pressure, and laboratory measurements.

Arm/Group Title	ER+ and/or PgR+ (Arm I)	ER- and PgR- (Arm II)
Arm/Group Description	Panobinostat - LBH589: hard gelatin...	Panobinostat - LBH589: hard gelatin...
Arm/Group Description	Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
All-Cause Mortality
	ER+ and/or PgR+ (Arm I)	ER- and PgR- (Arm II)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	ER+ and/or PgR+ (Arm I)	ER- and PgR- (Arm II)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	12/32 (37.50%)	8/20 (40.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/32 (0.00%)	1/20 (5.00%)
Neutropenia ^† 1	1/32 (3.13%)	0/20 (0.00%)
Thrombocytopenia ^† 1	4/32 (12.50%)	1/20 (5.00%)
Cardiac disorders
Atrial fibrillation ^† 1	1/32 (3.13%)	0/20 (0.00%)
Cardiac failure congestive ^† 1	1/32 (3.13%)	0/20 (0.00%)
Myocardial ischaemia ^† 1	1/32 (3.13%)	0/20 (0.00%)
Gastrointestinal disorders
Abdominal discomfort ^† 1	0/32 (0.00%)	1/20 (5.00%)
Ascites ^† 1	1/32 (3.13%)	0/20 (0.00%)
Constipation ^† 1	0/32 (0.00%)	2/20 (10.00%)
Rectal haemorrhage ^† 1	1/32 (3.13%)	0/20 (0.00%)
Vomiting ^† 1	1/32 (3.13%)	0/20 (0.00%)
General disorders
Fatigue ^† 1	1/32 (3.13%)	0/20 (0.00%)
General physical health deterioration ^† 1	1/32 (3.13%)	0/20 (0.00%)
Hepatobiliary disorders
Portal vein thrombosis ^† 1	1/32 (3.13%)	0/20 (0.00%)
Investigations
Ejection fraction decreased ^† 1	1/32 (3.13%)	0/20 (0.00%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/32 (3.13%)	0/20 (0.00%)
Dehydration ^† 1	1/32 (3.13%)	0/20 (0.00%)
Musculoskeletal and connective tissue disorders
Neck pain ^† 1	0/32 (0.00%)	1/20 (5.00%)
Reproductive system and breast disorders
Breast pain ^† 1	0/32 (0.00%)	1/20 (5.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	1/32 (3.13%)	0/20 (0.00%)
Pleural effusion ^† 1	0/32 (0.00%)	1/20 (5.00%)
Pulmonary embolism ^† 1	1/32 (3.13%)	0/20 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 18.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	ER+ and/or PgR+ (Arm I)	ER- and PgR- (Arm II)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	32/32 (100.00%)	20/20 (100.00%)
Blood and lymphatic system disorders
Neutropenia ^† 1	2/32 (6.25%)	1/20 (5.00%)
Thrombocytopenia ^† 1	7/32 (21.88%)	4/20 (20.00%)
Cardiac disorders
Palpitations ^† 1	0/32 (0.00%)	3/20 (15.00%)
Endocrine disorders
Hyperthyroidism ^† 1	3/32 (9.38%)	1/20 (5.00%)
Eye disorders
Lacrimation increased ^† 1	1/32 (3.13%)	2/20 (10.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	3/32 (9.38%)	2/20 (10.00%)
Abdominal pain upper ^† 1	4/32 (12.50%)	2/20 (10.00%)
Constipation ^† 1	12/32 (37.50%)	5/20 (25.00%)
Diarrhoea ^† 1	25/32 (78.13%)	15/20 (75.00%)
Dry mounth ^† 1	4/32 (12.50%)	4/20 (20.00%)
Dyspepsia ^† 1	3/32 (9.38%)	4/20 (20.00%)
Haemorrhoids ^† 1	2/32 (6.25%)	1/20 (5.00%)
Nausea ^† 1	28/32 (87.50%)	16/20 (80.00%)
Stomatitis ^† 1	6/32 (18.75%)	1/20 (5.00%)
Vomiting ^† 1	24/32 (75.00%)	11/20 (55.00%)
General disorders
Asthenia ^† 1	1/32 (3.13%)	2/20 (10.00%)
Chest pain ^† 1	1/32 (3.13%)	3/20 (15.00%)
Fatigue ^† 1	26/32 (81.25%)	15/20 (75.00%)
Mucosal inflammation ^† 1	1/32 (3.13%)	2/20 (10.00%)
Non-cardiac chest pain ^† 1	1/32 (3.13%)	3/20 (15.00%)
Oedema ^† 1	2/32 (6.25%)	0/20 (0.00%)
Oedema peripheral ^† 1	5/32 (15.63%)	7/20 (35.00%)
Pain ^† 1	1/32 (3.13%)	5/20 (25.00%)
Pyrexia ^† 1	2/32 (6.25%)	2/20 (10.00%)
Infections and infestations
Infection ^† 1	2/32 (6.25%)	0/20 (0.00%)
Lower respiratory tract infection ^† 1	1/32 (3.13%)	2/20 (10.00%)
Oral herpes ^† 1	0/32 (0.00%)	2/20 (10.00%)
Respiratory tract infection ^† 1	2/32 (6.25%)	0/20 (0.00%)
Sinusitis ^† 1	2/32 (6.25%)	0/20 (0.00%)
Upper respiratory infection ^† 1	2/32 (6.25%)	2/20 (10.00%)
Urinary tract infection ^† 1	2/32 (6.25%)	2/20 (10.00%)
Injury, poisoning and procedural complications
Contusion ^† 1	0/32 (0.00%)	2/20 (10.00%)
Investigations
Electrocardiogram abnormal ^† 1	2/32 (6.25%)	0/20 (0.00%)
Weight decreased ^† 1	8/32 (25.00%)	2/20 (10.00%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	14/32 (43.75%)	10/20 (50.00%)
Dehydration ^† 1	4/32 (12.50%)	1/20 (5.00%)
Hypocalcaemia ^† 1	3/32 (9.38%)	2/20 (10.00%)
Hypophosphataemia ^† 1	0/32 (0.00%)	2/20 (10.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	2/32 (6.25%)	1/20 (5.00%)
Back pain ^† 1	6/32 (18.75%)	5/20 (25.00%)
Bone pain ^† 1	2/32 (6.25%)	1/20 (5.00%)
Muscle spasms ^† 1	4/32 (12.50%)	3/20 (15.00%)
Musculoskeletal chest pain ^† 1	0/32 (0.00%)	3/20 (15.00%)
Myalgia ^† 1	2/32 (6.25%)	1/20 (5.00%)
Neck pain ^† 1	2/32 (6.25%)	2/20 (10.00%)
Pain in extremity ^† 1	4/32 (12.50%)	5/20 (25.00%)
Nervous system disorders
Dizziness ^† 1	5/32 (15.63%)	3/20 (15.00%)
Dysgeusia ^† 1	8/32 (25.00%)	4/20 (20.00%)
Headache ^† 1	5/32 (15.63%)	5/20 (25.00%)
Lethargy ^† 1	0/32 (0.00%)	3/20 (15.00%)
Neuralgia ^† 1	2/32 (6.25%)	1/20 (5.00%)
Syncope ^† 1	2/32 (6.25%)	0/20 (0.00%)
Tremor ^† 1	2/32 (6.25%)	0/20 (0.00%)
Psychiatric disorders
Anxiety ^† 1	5/32 (15.63%)	3/20 (15.00%)
Depression ^† 1	2/32 (6.25%)	1/20 (5.00%)
Insomnia ^† 1	5/32 (15.63%)	3/20 (15.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	4/32 (12.50%)	4/20 (20.00%)
Dyspnoea ^† 1	6/32 (18.75%)	8/20 (40.00%)
Epistaxis ^† 1	1/32 (3.13%)	4/20 (20.00%)
Nasal congestion ^† 1	3/32 (9.38%)	0/20 (0.00%)
Wheezing ^† 1	2/32 (6.25%)	0/20 (0.00%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	5/32 (15.63%)	3/20 (15.00%)
Dry skin ^† 1	3/32 (9.38%)	1/20 (5.00%)
Nail disorder ^† 1	3/32 (9.38%)	1/20 (5.00%)
Rash ^† 1	3/32 (9.38%)	2/20 (10.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 18.0

Limitations and Caveats

In Arm II, low recruitment resulted in insufficient data (and enrollment was stopped). In Arm I, the required number of tumor responses was not reached. Unable to determine efficacy (small sample); secondary objectives also removed from the protocol.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Valérie Bee-Muntenau, Director of Project Management
Organization:	Translational Research in Oncology (TRIO)
Phone:	+33 1 58 10 09 09
EMail:	Valerie.Bee@trioncology.org

Layout table for additonal information

Responsible Party:	Translational Research in Oncology
ClinicalTrials.gov Identifier:	NCT00777049
Other Study ID Numbers:	TRIO 017
First Submitted:	October 21, 2008
First Posted:	October 22, 2008
Results First Submitted:	May 26, 2016
Results First Posted:	July 15, 2016
Last Update Posted:	July 15, 2016

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