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Trial record 1 of 1 for:    NCT01958021
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Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) (MONALEESA-2)

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: NCT01958021
Recruitment Status : Active, not recruiting
First Posted : October 8, 2013
Results First Posted : May 12, 2017
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Advanced, Metastatic Breast Cancer
Interventions Drug: LEE011
Drug: Letrozole
Drug: LEE011 Placebo
Enrollment 668
Recruitment Details  
Pre-assignment Details Six-hundred and sixty-eight patients were randomized; 334 patients each to the ribociclib plus letrozole arm and the placebo plus letrozole arm. Four patients who were randomized to the placebo plus letrozole arm did not receive study treatment; three due to physician's decision and one due to subject/guardian decision.
Arm/Group Title LEE011 + Letrozole Placebo + Letrozole
Hide Arm/Group Description LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
Period Title: Overall Study
Started 334 334
Patients Untreated 0 4
Patients Treated 334 330
Completed 195 [1] 154 [1]
Not Completed 139 180
Reason Not Completed
Progressive disease             87             146
Adverse Event             25             7
Subject/guardian decision             12             13
Physician Decision             10             13
Protocol Violation             3             1
Death             2             0
[1]
Completed = Treatment ongoing
Arm/Group Title LEE011 + Letrozole Placebo + Letrozole Total
Hide Arm/Group Description LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole Total of all reporting groups
Overall Number of Baseline Participants 334 334 668
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS-population) consisted of all randomized patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 334 participants 334 participants 668 participants
61.4  (10.98) 61.9  (10.52) 61.6  (10.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 334 participants 334 participants 668 participants
Female
334
 100.0%
334
 100.0%
668
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression Free Survival (PFS) Per Investigator Assessment
Hide Description PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1
Time Frame Up to approximately 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS- population) consisted of all randomized patients.
Arm/Group Title LEE011 + Letrozole Placebo + Letrozole
Hide Arm/Group Description:
LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
Overall Number of Participants Analyzed 334 334
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(19.3 to NA)
14.7
(13.0 to 16.5)
[1]
N/A = not estimable as median PFS was not reached in the ribociclib arm
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEE011 + Letrozole, Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000329
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.556
Confidence Interval (2-Sided) 95%
0.429 to 0.720
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate (ORR) as Per Investigator Assessment
Hide Description Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time Frame Up to approximately 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS- population) consisted of all randomized patients.
Arm/Group Title LEE011 + Letrozole Placebo + Letrozole
Hide Arm/Group Description:
LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
Overall Number of Participants Analyzed 334 334
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.7
(35.4 to 46.0)
27.5
(22.8 to 32.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEE011 + Letrozole, Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000155
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time from date of randomization to the date of death from any cause.
Time Frame Up to approximately 65 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description Clinical Benefit Rate (CBR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1.
Time Frame Up to approximately 20 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score
Hide Description Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.
Time Frame Up to approximately 20.5 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Safety and Tolerability of LEE011
Hide Description Safety will be determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03.
Time Frame Up to approximately 21 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30
Hide Description The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.
Time Frame Up to approximately 20 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title QTc Interval
Hide Description Time between the start of the Q wave and the end of the T wave corrected for heart rate
Time Frame Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1
Outcome Measure Data Not Reported
Time Frame Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ribociclib 600mg + Letrozole 2.5mg Placebo + Letrozole 2.5mg
Hide Arm/Group Description LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
All-Cause Mortality
Ribociclib 600mg + Letrozole 2.5mg Placebo + Letrozole 2.5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ribociclib 600mg + Letrozole 2.5mg Placebo + Letrozole 2.5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   71/334 (21.26%)   39/330 (11.82%) 
Blood and lymphatic system disorders     
ANAEMIA  1  4/334 (1.20%)  1/330 (0.30%) 
FEBRILE NEUTROPENIA  1  4/334 (1.20%)  0/330 (0.00%) 
LEUKOCYTOSIS  1  1/334 (0.30%)  0/330 (0.00%) 
LEUKOPENIA  1  1/334 (0.30%)  0/330 (0.00%) 
NEUTROPENIA  1  2/334 (0.60%)  0/330 (0.00%) 
PANCYTOPENIA  1  1/334 (0.30%)  0/330 (0.00%) 
THROMBOCYTOPENIA  1  1/334 (0.30%)  0/330 (0.00%) 
Cardiac disorders     
ARRHYTHMIA  1  1/334 (0.30%)  0/330 (0.00%) 
ATRIAL FIBRILLATION  1  1/334 (0.30%)  0/330 (0.00%) 
CARDIAC FAILURE CONGESTIVE  1  1/334 (0.30%)  0/330 (0.00%) 
CARDIOMYOPATHY  1  1/334 (0.30%)  0/330 (0.00%) 
CORONARY ARTERY DISEASE  1  0/334 (0.00%)  1/330 (0.30%) 
Eye disorders     
GLAUCOMA  1  0/334 (0.00%)  1/330 (0.30%) 
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  1/334 (0.30%)  0/330 (0.00%) 
ABDOMINAL INCARCERATED HERNIA  1  1/334 (0.30%)  0/330 (0.00%) 
ABDOMINAL PAIN  1  5/334 (1.50%)  0/330 (0.00%) 
ABDOMINAL PAIN LOWER  1  0/334 (0.00%)  1/330 (0.30%) 
ABDOMINAL PAIN UPPER  1  0/334 (0.00%)  1/330 (0.30%) 
ASCITES  1  2/334 (0.60%)  0/330 (0.00%) 
CONSTIPATION  1  4/334 (1.20%)  0/330 (0.00%) 
DIARRHOEA  1  2/334 (0.60%)  0/330 (0.00%) 
DUODENAL OBSTRUCTION  1  0/334 (0.00%)  1/330 (0.30%) 
DUODENAL PERFORATION  1  1/334 (0.30%)  0/330 (0.00%) 
DYSPEPSIA  1  0/334 (0.00%)  1/330 (0.30%) 
FLATULENCE  1  1/334 (0.30%)  0/330 (0.00%) 
GASTRIC ANTRAL VASCULAR ECTASIA  1  1/334 (0.30%)  0/330 (0.00%) 
GASTROINTESTINAL WALL THICKENING  1  0/334 (0.00%)  1/330 (0.30%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/334 (0.00%)  1/330 (0.30%) 
HAEMATEMESIS  1  1/334 (0.30%)  0/330 (0.00%) 
INGUINAL HERNIA  1  1/334 (0.30%)  0/330 (0.00%) 
NAUSEA  1  4/334 (1.20%)  2/330 (0.61%) 
OBSTRUCTION GASTRIC  1  1/334 (0.30%)  0/330 (0.00%) 
VOMITING  1  5/334 (1.50%)  2/330 (0.61%) 
General disorders     
GENERAL PHYSICAL HEALTH DETERIORATION  1  3/334 (0.90%)  1/330 (0.30%) 
MALAISE  1  1/334 (0.30%)  0/330 (0.00%) 
NON-CARDIAC CHEST PAIN  1  2/334 (0.60%)  0/330 (0.00%) 
PYREXIA  1  2/334 (0.60%)  0/330 (0.00%) 
SUDDEN DEATH  1  1/334 (0.30%)  0/330 (0.00%) 
Hepatobiliary disorders     
AUTOIMMUNE HEPATITIS  1  1/334 (0.30%)  0/330 (0.00%) 
CHOLECYSTITIS  1  2/334 (0.60%)  0/330 (0.00%) 
CHOLECYSTITIS ACUTE  1  1/334 (0.30%)  0/330 (0.00%) 
HEPATIC FAILURE  1  2/334 (0.60%)  0/330 (0.00%) 
HEPATOCELLULAR INJURY  1  1/334 (0.30%)  0/330 (0.00%) 
HEPATOTOXICITY  1  3/334 (0.90%)  0/330 (0.00%) 
Infections and infestations     
BRONCHITIS  1  0/334 (0.00%)  1/330 (0.30%) 
CELLULITIS  1  1/334 (0.30%)  1/330 (0.30%) 
CLOSTRIDIUM DIFFICILE INFECTION  1  1/334 (0.30%)  0/330 (0.00%) 
ERYSIPELAS  1  1/334 (0.30%)  0/330 (0.00%) 
PNEUMONIA  1  3/334 (0.90%)  1/330 (0.30%) 
PYELONEPHRITIS  1  0/334 (0.00%)  1/330 (0.30%) 
PYELONEPHRITIS ACUTE  1  0/334 (0.00%)  1/330 (0.30%) 
RETROPERITONEAL ABSCESS  1  0/334 (0.00%)  1/330 (0.30%) 
SEPSIS  1  3/334 (0.90%)  0/330 (0.00%) 
SKIN INFECTION  1  0/334 (0.00%)  1/330 (0.30%) 
URINARY TRACT INFECTION  1  2/334 (0.60%)  0/330 (0.00%) 
UROSEPSIS  1  1/334 (0.30%)  0/330 (0.00%) 
Injury, poisoning and procedural complications     
FEMORAL NECK FRACTURE  1  0/334 (0.00%)  1/330 (0.30%) 
FEMUR FRACTURE  1  2/334 (0.60%)  0/330 (0.00%) 
HIP FRACTURE  1  0/334 (0.00%)  1/330 (0.30%) 
HUMERUS FRACTURE  1  1/334 (0.30%)  0/330 (0.00%) 
INFLAMMATION OF WOUND  1  0/334 (0.00%)  1/330 (0.30%) 
OVERDOSE  1  1/334 (0.30%)  0/330 (0.00%) 
RADIUS FRACTURE  1  1/334 (0.30%)  0/330 (0.00%) 
SPINAL COMPRESSION FRACTURE  1  0/334 (0.00%)  2/330 (0.61%) 
SPINAL FRACTURE  1  1/334 (0.30%)  0/330 (0.00%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  4/334 (1.20%)  0/330 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/334 (0.90%)  0/330 (0.00%) 
BLOOD BILIRUBIN INCREASED  1  1/334 (0.30%)  0/330 (0.00%) 
BLOOD CREATININE INCREASED  1  1/334 (0.30%)  0/330 (0.00%) 
BLOOD THYROID STIMULATING HORMONE DECREASED  1  0/334 (0.00%)  1/330 (0.30%) 
LYMPHOCYTE COUNT DECREASED  1  1/334 (0.30%)  0/330 (0.00%) 
NEUTROPHIL COUNT DECREASED  1  1/334 (0.30%)  0/330 (0.00%) 
TRANSAMINASES INCREASED  1  1/334 (0.30%)  0/330 (0.00%) 
WAIST CIRCUMFERENCE INCREASED  1  1/334 (0.30%)  0/330 (0.00%) 
WEIGHT DECREASED  1  1/334 (0.30%)  0/330 (0.00%) 
WHITE BLOOD CELL COUNT DECREASED  1  1/334 (0.30%)  0/330 (0.00%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  1/334 (0.30%)  0/330 (0.00%) 
DEHYDRATION  1  2/334 (0.60%)  1/330 (0.30%) 
ELECTROLYTE IMBALANCE  1  1/334 (0.30%)  0/330 (0.00%) 
HYPERCALCAEMIA  1  0/334 (0.00%)  1/330 (0.30%) 
HYPOGLYCAEMIA  1  1/334 (0.30%)  0/330 (0.00%) 
HYPOKALAEMIA  1  0/334 (0.00%)  1/330 (0.30%) 
HYPOPHOSPHATAEMIA  1  1/334 (0.30%)  0/330 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/334 (0.30%)  0/330 (0.00%) 
BACK PAIN  1  3/334 (0.90%)  1/330 (0.30%) 
BONE PAIN  1  1/334 (0.30%)  0/330 (0.00%) 
HAEMARTHROSIS  1  1/334 (0.30%)  0/330 (0.00%) 
PATHOLOGICAL FRACTURE  1  0/334 (0.00%)  1/330 (0.30%) 
SPINAL PAIN  1  1/334 (0.30%)  0/330 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BASAL CELL CARCINOMA  1  0/334 (0.00%)  1/330 (0.30%) 
BLADDER CANCER  1  1/334 (0.30%)  0/330 (0.00%) 
MALIGNANT MELANOMA IN SITU  1  1/334 (0.30%)  0/330 (0.00%) 
MENINGIOMA  1  0/334 (0.00%)  1/330 (0.30%) 
METASTASES TO CENTRAL NERVOUS SYSTEM  1  0/334 (0.00%)  1/330 (0.30%) 
METASTASES TO MENINGES  1  1/334 (0.30%)  0/330 (0.00%) 
ONCOCYTOMA  1  1/334 (0.30%)  0/330 (0.00%) 
SQUAMOUS CELL CARCINOMA  1  1/334 (0.30%)  0/330 (0.00%) 
TUMOUR PAIN  1  0/334 (0.00%)  1/330 (0.30%) 
UTERINE LEIOMYOMA  1  1/334 (0.30%)  0/330 (0.00%) 
Nervous system disorders     
DEPRESSED LEVEL OF CONSCIOUSNESS  1  1/334 (0.30%)  0/330 (0.00%) 
DIZZINESS  1  3/334 (0.90%)  0/330 (0.00%) 
EPILEPSY  1  0/334 (0.00%)  1/330 (0.30%) 
HAEMORRHAGE INTRACRANIAL  1  0/334 (0.00%)  1/330 (0.30%) 
HEADACHE  1  0/334 (0.00%)  1/330 (0.30%) 
MIGRAINE  1  1/334 (0.30%)  0/330 (0.00%) 
PARAESTHESIA  1  0/334 (0.00%)  1/330 (0.30%) 
SPINAL CORD COMPRESSION  1  1/334 (0.30%)  1/330 (0.30%) 
SYNCOPE  1  3/334 (0.90%)  0/330 (0.00%) 
Psychiatric disorders     
CONFUSIONAL STATE  1  1/334 (0.30%)  0/330 (0.00%) 
MENTAL STATUS CHANGES  1  2/334 (0.60%)  1/330 (0.30%) 
Renal and urinary disorders     
ACUTE KIDNEY INJURY  1  1/334 (0.30%)  1/330 (0.30%) 
RENAL FAILURE  1  1/334 (0.30%)  1/330 (0.30%) 
Respiratory, thoracic and mediastinal disorders     
ASTHMA  1  1/334 (0.30%)  0/330 (0.00%) 
DYSPNOEA  1  4/334 (1.20%)  1/330 (0.30%) 
HYPOXIA  1  1/334 (0.30%)  0/330 (0.00%) 
PLEURAL EFFUSION  1  2/334 (0.60%)  4/330 (1.21%) 
PLEURAL FIBROSIS  1  1/334 (0.30%)  0/330 (0.00%) 
PNEUMOTHORAX  1  1/334 (0.30%)  0/330 (0.00%) 
PULMONARY EMBOLISM  1  2/334 (0.60%)  0/330 (0.00%) 
PULMONARY HAEMORRHAGE  1  1/334 (0.30%)  0/330 (0.00%) 
PULMONARY OEDEMA  1  1/334 (0.30%)  0/330 (0.00%) 
Skin and subcutaneous tissue disorders     
ERYTHEMA  1  1/334 (0.30%)  0/330 (0.00%) 
Vascular disorders     
HYPERTENSION  1  0/334 (0.00%)  1/330 (0.30%) 
HYPOTENSION  1  2/334 (0.60%)  0/330 (0.00%) 
ORTHOSTATIC HYPOTENSION  1  1/334 (0.30%)  0/330 (0.00%) 
SUBCLAVIAN VEIN THROMBOSIS  1  0/334 (0.00%)  1/330 (0.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ribociclib 600mg + Letrozole 2.5mg Placebo + Letrozole 2.5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   329/334 (98.50%)   308/330 (93.33%) 
Blood and lymphatic system disorders     
ANAEMIA  1  59/334 (17.66%)  15/330 (4.55%) 
LEUKOPENIA  1  51/334 (15.27%)  9/330 (2.73%) 
NEUTROPENIA  1  203/334 (60.78%)  14/330 (4.24%) 
THROMBOCYTOPENIA  1  19/334 (5.69%)  2/330 (0.61%) 
Ear and labyrinth disorders     
VERTIGO  1  17/334 (5.09%)  5/330 (1.52%) 
Eye disorders     
DRY EYE  1  19/334 (5.69%)  7/330 (2.12%) 
LACRIMATION INCREASED  1  23/334 (6.89%)  6/330 (1.82%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  30/334 (8.98%)  25/330 (7.58%) 
ABDOMINAL PAIN UPPER  1  21/334 (6.29%)  18/330 (5.45%) 
CONSTIPATION  1  80/334 (23.95%)  63/330 (19.09%) 
DIARRHOEA  1  117/334 (35.03%)  73/330 (22.12%) 
DRY MOUTH  1  32/334 (9.58%)  31/330 (9.39%) 
DYSPEPSIA  1  22/334 (6.59%)  14/330 (4.24%) 
NAUSEA  1  171/334 (51.20%)  93/330 (28.18%) 
STOMATITIS  1  41/334 (12.28%)  22/330 (6.67%) 
VOMITING  1  95/334 (28.44%)  50/330 (15.15%) 
General disorders     
ASTHENIA  1  43/334 (12.87%)  38/330 (11.52%) 
FATIGUE  1  122/334 (36.53%)  99/330 (30.00%) 
INFLUENZA LIKE ILLNESS  1  16/334 (4.79%)  18/330 (5.45%) 
NON-CARDIAC CHEST PAIN  1  14/334 (4.19%)  21/330 (6.36%) 
OEDEMA PERIPHERAL  1  41/334 (12.28%)  33/330 (10.00%) 
PYREXIA  1  40/334 (11.98%)  18/330 (5.45%) 
Infections and infestations     
INFLUENZA  1  18/334 (5.39%)  12/330 (3.64%) 
NASOPHARYNGITIS  1  25/334 (7.49%)  19/330 (5.76%) 
UPPER RESPIRATORY TRACT INFECTION  1  35/334 (10.48%)  35/330 (10.61%) 
URINARY TRACT INFECTION  1  35/334 (10.48%)  27/330 (8.18%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  50/334 (14.97%)  13/330 (3.94%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  49/334 (14.67%)  12/330 (3.64%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  15/334 (4.49%)  18/330 (5.45%) 
BLOOD CREATININE INCREASED  1  23/334 (6.89%)  3/330 (0.91%) 
LYMPHOCYTE COUNT DECREASED  1  21/334 (6.29%)  3/330 (0.91%) 
NEUTROPHIL COUNT DECREASED  1  63/334 (18.86%)  3/330 (0.91%) 
WEIGHT DECREASED  1  20/334 (5.99%)  11/330 (3.33%) 
WHITE BLOOD CELL COUNT DECREASED  1  63/334 (18.86%)  5/330 (1.52%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  61/334 (18.26%)  50/330 (15.15%) 
HYPERGLYCAEMIA  1  17/334 (5.09%)  14/330 (4.24%) 
HYPOCALCAEMIA  1  17/334 (5.09%)  6/330 (1.82%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  91/334 (27.25%)  95/330 (28.79%) 
BACK PAIN  1  66/334 (19.76%)  58/330 (17.58%) 
BONE PAIN  1  23/334 (6.89%)  35/330 (10.61%) 
MUSCLE SPASMS  1  11/334 (3.29%)  19/330 (5.76%) 
MUSCULOSKELETAL CHEST PAIN  1  16/334 (4.79%)  22/330 (6.67%) 
MUSCULOSKELETAL PAIN  1  26/334 (7.78%)  39/330 (11.82%) 
MYALGIA  1  22/334 (6.59%)  21/330 (6.36%) 
PAIN IN EXTREMITY  1  35/334 (10.48%)  40/330 (12.12%) 
Nervous system disorders     
DIZZINESS  1  39/334 (11.68%)  43/330 (13.03%) 
DYSGEUSIA  1  31/334 (9.28%)  19/330 (5.76%) 
HEADACHE  1  74/334 (22.16%)  63/330 (19.09%) 
Psychiatric disorders     
ANXIETY  1  26/334 (7.78%)  20/330 (6.06%) 
DEPRESSION  1  24/334 (7.19%)  23/330 (6.97%) 
INSOMNIA  1  39/334 (11.68%)  31/330 (9.39%) 
Reproductive system and breast disorders     
BREAST PAIN  1  15/334 (4.49%)  22/330 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  65/334 (19.46%)  59/330 (17.88%) 
DYSPNOEA  1  37/334 (11.08%)  28/330 (8.48%) 
OROPHARYNGEAL PAIN  1  19/334 (5.69%)  15/330 (4.55%) 
Skin and subcutaneous tissue disorders     
ALOPECIA  1  111/334 (33.23%)  51/330 (15.45%) 
DRY SKIN  1  27/334 (8.08%)  10/330 (3.03%) 
PRURITUS  1  45/334 (13.47%)  19/330 (5.76%) 
RASH  1  57/334 (17.07%)  26/330 (7.88%) 
Vascular disorders     
HOT FLUSH  1  70/334 (20.96%)  78/330 (23.64%) 
HYPERTENSION  1  48/334 (14.37%)  49/330 (14.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Four patients who were randomized to the placebo plus letrozole arm did not receive study treatment and so are not part of the Safety Set.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01958021    
Other Study ID Numbers: CLEE011A2301
2013-003084-61 ( EudraCT Number )
First Submitted: October 4, 2013
First Posted: October 8, 2013
Results First Submitted: April 4, 2017
Results First Posted: May 12, 2017
Last Update Posted: May 4, 2022