Trial Outcomes & Findings for Study of Panobinostat Monotherapy in Women With HER2-negative Locally Recurrent or Metastatic Breast Cancer (NCT NCT00777049)

Last Updated: 2016-07-15

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

6 years and 2 months

Results posted on

2016-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	ER+ and/or PgR+ (Arm I) Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	ER- and PgR- (Arm II) Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
Overall Study STARTED	33	21
Overall Study COMPLETED	32	20
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ER+ and/or PgR+ (Arm I) Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	ER- and PgR- (Arm II) Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
Overall Study Withdrawal by Subject	1	0
Overall Study No treatment (elevated liver enzymes)	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ER+ and/or PgR+ (Arm I) n=33 Participants Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	ER- and PgR- (Arm II) n=21 Participants Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 9.5 • n=5 Participants	52.8 years STANDARD_DEVIATION 10.7 • n=7 Participants	57.4 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	21 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race - White	31 participants n=5 Participants	20 participants n=7 Participants	51 participants n=5 Participants
Race/Ethnicity, Customized Race - Black or African American	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Race - Asian	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment Belgium	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment France	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Ireland	10 participants n=5 Participants	1 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Ethnicity Hispanic or Latino	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Ethnicity Not Hispanic or Latino	31 participants n=5 Participants	18 participants n=7 Participants	49 participants n=5 Participants
Menopausal Status Premenopausal	0 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants
Menopausal Status Postmenopausal	33 participants n=5 Participants	16 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 years and 2 months

Outcome measures

Outcome measures
Measure	ER+ and/or PgR+ (Arm I) n=33 Participants Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	ER- and PgR- (Arm II) n=21 Participants Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
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. Complete Response	0 participants	1 participants
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. Partial Response	1 participants	0 participants
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. Stable Disease / Incompete Response	13 participants	4 participants
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. Progressive Disease	14 participants	14 participants
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. Missing	5 participants	2 participants

Adverse Events

ER+ and/or PgR+ (Arm I)

Serious events: 12 serious events

Other events: 32 other events

Deaths: 0 deaths

ER- and PgR- (Arm II)

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Valérie Bee-Muntenau, Director of Project Management

Translational Research in Oncology (TRIO)

Phone: +33 1 58 10 09 09

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ER+ and/or PgR+ (Arm I) n=32 participants at risk Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg	ER- and PgR- (Arm II) n=20 participants at risk Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
Blood and lymphatic system disorders Anaemia	0.00% 0/32 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.	5.0% 1/20 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.
Blood and lymphatic system disorders Neutropenia	3.1% 1/32 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.	0.00% 0/20 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.
Blood and lymphatic system disorders Thrombocytopenia	12.5% 4/32 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.	5.0% 1/20 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.
Cardiac disorders Atrial fibrillation	3.1% 1/32 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.	0.00% 0/20 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.
Cardiac disorders Cardiac failure congestive	3.1% 1/32 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.	0.00% 0/20 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.
Cardiac disorders Myocardial ischaemia	3.1% 1/32 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.	0.00% 0/20 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.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/32 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.	5.0% 1/20 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.
Gastrointestinal disorders Ascites	3.1% 1/32 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.	0.00% 0/20 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.
Gastrointestinal disorders Constipation	0.00% 0/32 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.	10.0% 2/20 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.
Gastrointestinal disorders Rectal haemorrhage	3.1% 1/32 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.	0.00% 0/20 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.
Gastrointestinal disorders Vomiting	3.1% 1/32 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.	0.00% 0/20 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.
General disorders Fatigue	3.1% 1/32 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.	0.00% 0/20 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.
General disorders General physical health deterioration	3.1% 1/32 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.	0.00% 0/20 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.
Hepatobiliary disorders Portal vein thrombosis	3.1% 1/32 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.	0.00% 0/20 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.
Investigations Ejection fraction decreased	3.1% 1/32 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.	0.00% 0/20 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.
Metabolism and nutrition disorders Decreased appetite	3.1% 1/32 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.	0.00% 0/20 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.
Metabolism and nutrition disorders Dehydration	3.1% 1/32 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.	0.00% 0/20 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.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/32 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.	5.0% 1/20 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.
Reproductive system and breast disorders Breast pain	0.00% 0/32 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.	5.0% 1/20 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.1% 1/32 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.	0.00% 0/20 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/32 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.	5.0% 1/20 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.1% 1/32 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.	0.00% 0/20 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.