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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ER+ and/or PgR+ (Arm I) ER- and PgR- (Arm II)
Hide 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
Arm/Group Title ER+ and/or PgR+ (Arm I) ER- and PgR- (Arm II) Total
Hide 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
Hide 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
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ER+ and/or PgR+ (Arm I) ER- and PgR- (Arm II)
Hide 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
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)
Hide 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   --/--   --/-- 
Hide 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
Hide 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
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.
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