Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. (MONALEESA-3)

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: NCT02422615
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Results First Posted : September 19, 2018
Last Update Posted : April 16, 2019
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 Breast Cancer
Interventions Drug: Ribociclib
Drug: fulvestrant
Drug: Ribociclib placebo
Enrollment 726
Recruitment Details A total of 660 patients were planned and 726 patients were randomized in a ratio of 2:1 with 484 patients in the ribociclib plus fulvestrant arm and 242 patients in the placebo plus fulvestrant arm.
Pre-assignment Details  
Arm/Group Title Ribociclib + Fulvestrant Ribociclib Placebo + Fulvestrant
Hide Arm/Group Description Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
Period Title: Overall Study
Started 484 242
Untreated 1 1
Completed [1] 204 76
Not Completed 280 166
Reason Not Completed
Progressive disease             193             142
Adverse Event             41             10
Physician Decision             22             7
Subject/guardian decision             21             5
Death             2             0
Protocol Violation             1             1
Technical problems             0             1
[1]
Completed = Treatment ongoing at the time of the cut-off 3-Nov-2017.
Arm/Group Title Ribociclib + Fulvestrant Ribociclib Placebo + Fulvestrant Total
Hide Arm/Group Description Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 Total of all reporting groups
Overall Number of Baseline Participants 484 242 726
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 484 participants 242 participants 726 participants
63.4  (9.78) 62.8  (10.59) 63.2  (10.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 484 participants 242 participants 726 participants
Female
484
 100.0%
242
 100.0%
726
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 484 participants 242 participants 726 participants
Caucasian
406
  83.9%
213
  88.0%
619
  85.3%
Asian
45
   9.3%
18
   7.4%
63
   8.7%
Native American
5
   1.0%
1
   0.4%
6
   0.8%
Black
3
   0.6%
2
   0.8%
5
   0.7%
Other
10
   2.1%
3
   1.2%
13
   1.8%
Unkown
15
   3.1%
5
   2.1%
20
   2.8%
1.Primary Outcome
Title Progression Free Survival (PFS) Per Investigator Assessment
Hide Description The primary endpoint of the study is 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 will be assessed via a local radiology assessment according to RECIST 1.1
Time Frame Up to approximately 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS population) consisted of all randomized patients.
Arm/Group Title Ribociclib + Fulvestrant Ribociclib Placebo + Fulvestrant
Hide Arm/Group Description:
Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
Overall Number of Participants Analyzed 484 242
Median (95% Confidence Interval)
Unit of Measure: Months
20.5
(18.5 to 23.5)
12.8
(10.9 to 16.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ribociclib + Fulvestrant, Ribociclib Placebo + Fulvestrant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000041
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.593
Confidence Interval (2-Sided) 95%
0.480 to 0.732
Estimation Comments [Not Specified]
2.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 58 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Progression Free Survival (PFS) Per Blinded Independant Review Committee (BICR)
Hide Description The primary endpoint of the study is 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 will be assessed via a BICR according to RECIST 1.1
Time Frame Up to approximately 26 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Response Rate (ORR)
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.
Time Frame Up to approximately 26 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 26 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 26 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 26 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change From Baseline in the Global Health Status/QoL Scale Score of the EORTC QLQ-C30
Hide Description Change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized.
Time Frame Up to approximately 26 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description Clinical benefit rate (CBR), defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1
Time Frame Up to approximately 26 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Time to Response (TTR)
Hide Description Time from randomization to the first documented and confirmed response (complete response or partial response) as defined by RECIST 1.1
Time Frame Up to approximately 26 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1
Time Frame Up to approximately 26 months
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 The adverse events summary tables included ‘on-treatment’ events/assessments, i.e. those collected on or after the first date of study treatment and collected no later than 30 days after the date of last study treatment administration.
 
Arm/Group Title Ribociclib + Fulvestrant Ribociclib Placebo + Fulvestrant
Hide Arm/Group Description Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
All-Cause Mortality
Ribociclib + Fulvestrant Ribociclib Placebo + Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   13/483 (2.69%)   8/241 (3.32%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ribociclib + Fulvestrant Ribociclib Placebo + Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   138/483 (28.57%)   40/241 (16.60%) 
Blood and lymphatic system disorders     
Anaemia  1  6/483 (1.24%)  0/241 (0.00%) 
Febrile neutropenia  1  5/483 (1.04%)  0/241 (0.00%) 
Neutropenia  1  6/483 (1.24%)  0/241 (0.00%) 
Pancytopenia  1  2/483 (0.41%)  0/241 (0.00%) 
Thrombocytopenia  1  3/483 (0.62%)  0/241 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/483 (0.21%)  0/241 (0.00%) 
Angina pectoris  1  2/483 (0.41%)  0/241 (0.00%) 
Atrial fibrillation  1  1/483 (0.21%)  0/241 (0.00%) 
Atrioventricular block second degree  1  1/483 (0.21%)  0/241 (0.00%) 
Bradycardia  1  1/483 (0.21%)  0/241 (0.00%) 
Cardiac failure  1  2/483 (0.41%)  0/241 (0.00%) 
Cardiac failure congestive  1  1/483 (0.21%)  0/241 (0.00%) 
Cardiomyopathy  1  0/483 (0.00%)  1/241 (0.41%) 
Cardiopulmonary failure  1  1/483 (0.21%)  0/241 (0.00%) 
Ischaemic cardiomyopathy  1  1/483 (0.21%)  0/241 (0.00%) 
Myocardial infarction  1  1/483 (0.21%)  0/241 (0.00%) 
Pericardial effusion  1  1/483 (0.21%)  0/241 (0.00%) 
Supraventricular tachycardia  1  1/483 (0.21%)  1/241 (0.41%) 
Tachyarrhythmia  1  1/483 (0.21%)  0/241 (0.00%) 
Tachycardia  1  0/483 (0.00%)  1/241 (0.41%) 
Ventricular arrhythmia  1  1/483 (0.21%)  0/241 (0.00%) 
Ventricular tachycardia  1  0/483 (0.00%)  1/241 (0.41%) 
Ear and labyrinth disorders     
Vertigo  1  1/483 (0.21%)  0/241 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  0/483 (0.00%)  1/241 (0.41%) 
Eye disorders     
Myopia  1  1/483 (0.21%)  0/241 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  5/483 (1.04%)  1/241 (0.41%) 
Abdominal pain upper  1  2/483 (0.41%)  0/241 (0.00%) 
Ascites  1  1/483 (0.21%)  1/241 (0.41%) 
Constipation  1  3/483 (0.62%)  0/241 (0.00%) 
Diarrhoea  1  1/483 (0.21%)  1/241 (0.41%) 
Dysphagia  1  1/483 (0.21%)  0/241 (0.00%) 
Faecaloma  1  1/483 (0.21%)  0/241 (0.00%) 
Gastrointestinal haemorrhage  1  0/483 (0.00%)  1/241 (0.41%) 
Gastrointestinal perforation  1  1/483 (0.21%)  0/241 (0.00%) 
Gastrooesophageal reflux disease  1  1/483 (0.21%)  0/241 (0.00%) 
Ileus  1  2/483 (0.41%)  0/241 (0.00%) 
Intestinal obstruction  1  1/483 (0.21%)  0/241 (0.00%) 
Nausea  1  7/483 (1.45%)  0/241 (0.00%) 
Small intestinal obstruction  1  2/483 (0.41%)  0/241 (0.00%) 
Vomiting  1  7/483 (1.45%)  1/241 (0.41%) 
General disorders     
Asthenia  1  2/483 (0.41%)  0/241 (0.00%) 
Fatigue  1  2/483 (0.41%)  0/241 (0.00%) 
General physical health deterioration  1  2/483 (0.41%)  2/241 (0.83%) 
Non-cardiac chest pain  1  4/483 (0.83%)  0/241 (0.00%) 
Pyrexia  1  5/483 (1.04%)  1/241 (0.41%) 
Systemic inflammatory response syndrome  1  1/483 (0.21%)  0/241 (0.00%) 
Terminal state  1  1/483 (0.21%)  0/241 (0.00%) 
Hepatobiliary disorders     
Acute hepatic failure  1  0/483 (0.00%)  2/241 (0.83%) 
Cholelithiasis  1  2/483 (0.41%)  1/241 (0.41%) 
Drug-induced liver injury  1  1/483 (0.21%)  1/241 (0.41%) 
Hepatic failure  1  1/483 (0.21%)  0/241 (0.00%) 
Hepatocellular injury  1  1/483 (0.21%)  0/241 (0.00%) 
Hepatotoxicity  1  1/483 (0.21%)  0/241 (0.00%) 
Immune system disorders     
Anaphylactic shock  1  1/483 (0.21%)  0/241 (0.00%) 
Infections and infestations     
Anal abscess  1  1/483 (0.21%)  0/241 (0.00%) 
Breast cellulitis  1  1/483 (0.21%)  0/241 (0.00%) 
Bronchitis  1  1/483 (0.21%)  0/241 (0.00%) 
Cystitis  1  1/483 (0.21%)  0/241 (0.00%) 
Erysipelas  1  1/483 (0.21%)  0/241 (0.00%) 
Escherichia pyelonephritis  1  1/483 (0.21%)  0/241 (0.00%) 
Gastroenteritis  1  1/483 (0.21%)  0/241 (0.00%) 
Influenza  1  1/483 (0.21%)  1/241 (0.41%) 
Lower respiratory tract infection  1  1/483 (0.21%)  1/241 (0.41%) 
Lung infection  1  0/483 (0.00%)  1/241 (0.41%) 
Neutropenic sepsis  1  1/483 (0.21%)  0/241 (0.00%) 
Pneumonia  1  9/483 (1.86%)  0/241 (0.00%) 
Postoperative wound infection  1  1/483 (0.21%)  0/241 (0.00%) 
Pyelonephritis  1  1/483 (0.21%)  0/241 (0.00%) 
Respiratory tract infection  1  1/483 (0.21%)  0/241 (0.00%) 
Sepsis  1  1/483 (0.21%)  0/241 (0.00%) 
Urinary tract infection  1  4/483 (0.83%)  2/241 (0.83%) 
Urosepsis  1  1/483 (0.21%)  1/241 (0.41%) 
Viral infection  1  1/483 (0.21%)  0/241 (0.00%) 
Wound infection  1  1/483 (0.21%)  0/241 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/483 (0.21%)  0/241 (0.00%) 
Fall  1  1/483 (0.21%)  0/241 (0.00%) 
Femoral neck fracture  1  1/483 (0.21%)  0/241 (0.00%) 
Femur fracture  1  1/483 (0.21%)  1/241 (0.41%) 
Hip fracture  1  3/483 (0.62%)  1/241 (0.41%) 
Humerus fracture  1  0/483 (0.00%)  1/241 (0.41%) 
Infusion related reaction  1  0/483 (0.00%)  1/241 (0.41%) 
Multiple fractures  1  1/483 (0.21%)  0/241 (0.00%) 
Overdose  1  1/483 (0.21%)  0/241 (0.00%) 
Rib fracture  1  1/483 (0.21%)  0/241 (0.00%) 
Spinal fracture  1  1/483 (0.21%)  0/241 (0.00%) 
Subdural haematoma  1  1/483 (0.21%)  1/241 (0.41%) 
Toxicity to various agents  1  1/483 (0.21%)  0/241 (0.00%) 
Upper limb fracture  1  1/483 (0.21%)  0/241 (0.00%) 
Wound dehiscence  1  1/483 (0.21%)  0/241 (0.00%) 
Wrist fracture  1  1/483 (0.21%)  0/241 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  4/483 (0.83%)  0/241 (0.00%) 
Aspartate aminotransferase increased  1  3/483 (0.62%)  0/241 (0.00%) 
Blood alkaline phosphatase increased  1  0/483 (0.00%)  1/241 (0.41%) 
Blood creatinine increased  1  2/483 (0.41%)  0/241 (0.00%) 
Blood phosphorus decreased  1  1/483 (0.21%)  0/241 (0.00%) 
Electrocardiogram QT prolonged  1  2/483 (0.41%)  1/241 (0.41%) 
Hepatic enzyme increased  1  1/483 (0.21%)  0/241 (0.00%) 
Liver function test abnormal  1  1/483 (0.21%)  0/241 (0.00%) 
Liver function test increased  1  1/483 (0.21%)  0/241 (0.00%) 
White blood cell count decreased  1  1/483 (0.21%)  0/241 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/483 (0.21%)  0/241 (0.00%) 
Dehydration  1  3/483 (0.62%)  1/241 (0.41%) 
Hypercalcaemia  1  2/483 (0.41%)  2/241 (0.83%) 
Hypocalcaemia  1  2/483 (0.41%)  0/241 (0.00%) 
Hypokalaemia  1  1/483 (0.21%)  0/241 (0.00%) 
Hyponatraemia  1  2/483 (0.41%)  0/241 (0.00%) 
Hypophagia  1  0/483 (0.00%)  1/241 (0.41%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/483 (0.21%)  1/241 (0.41%) 
Back pain  1  2/483 (0.41%)  1/241 (0.41%) 
Bone pain  1  1/483 (0.21%)  1/241 (0.41%) 
Osteonecrosis of jaw  1  0/483 (0.00%)  1/241 (0.41%) 
Pain in extremity  1  1/483 (0.21%)  1/241 (0.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  0/483 (0.00%)  1/241 (0.41%) 
Endometrial cancer  1  0/483 (0.00%)  1/241 (0.41%) 
Malignant melanoma  1  0/483 (0.00%)  1/241 (0.41%) 
Malignant pleural effusion  1  1/483 (0.21%)  0/241 (0.00%) 
Metastases to central nervous system  1  1/483 (0.21%)  1/241 (0.41%) 
Metastases to lung  1  0/483 (0.00%)  1/241 (0.41%) 
Metastases to peritoneum  1  1/483 (0.21%)  0/241 (0.00%) 
Squamous cell carcinoma of skin  1  1/483 (0.21%)  0/241 (0.00%) 
Transitional cell carcinoma  1  1/483 (0.21%)  0/241 (0.00%) 
Tumour pain  1  1/483 (0.21%)  0/241 (0.00%) 
Uterine cancer  1  0/483 (0.00%)  1/241 (0.41%) 
Nervous system disorders     
Carotid artery stenosis  1  1/483 (0.21%)  0/241 (0.00%) 
Cerebral haemorrhage  1  1/483 (0.21%)  1/241 (0.41%) 
Cerebral infarction  1  1/483 (0.21%)  0/241 (0.00%) 
Cerebral ischaemia  1  1/483 (0.21%)  0/241 (0.00%) 
Cerebrovascular accident  1  1/483 (0.21%)  1/241 (0.41%) 
Dizziness  1  4/483 (0.83%)  0/241 (0.00%) 
Dysarthria  1  1/483 (0.21%)  0/241 (0.00%) 
Headache  1  2/483 (0.41%)  0/241 (0.00%) 
Hemiparesis  1  1/483 (0.21%)  0/241 (0.00%) 
Ischaemic stroke  1  1/483 (0.21%)  0/241 (0.00%) 
Presyncope  1  1/483 (0.21%)  1/241 (0.41%) 
Seizure  1  1/483 (0.21%)  0/241 (0.00%) 
Somnolence  1  1/483 (0.21%)  0/241 (0.00%) 
Spinal cord compression  1  2/483 (0.41%)  0/241 (0.00%) 
Syncope  1  1/483 (0.21%)  0/241 (0.00%) 
Transient ischaemic attack  1  1/483 (0.21%)  0/241 (0.00%) 
Trigeminal neuralgia  1  1/483 (0.21%)  0/241 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/483 (0.21%)  1/241 (0.41%) 
Confusional state  1  1/483 (0.21%)  0/241 (0.00%) 
Delirium  1  1/483 (0.21%)  0/241 (0.00%) 
Disorientation  1  1/483 (0.21%)  0/241 (0.00%) 
Mental status changes  1  0/483 (0.00%)  1/241 (0.41%) 
Renal and urinary disorders     
Acute kidney injury  1  5/483 (1.04%)  0/241 (0.00%) 
Prerenal failure  1  1/483 (0.21%)  0/241 (0.00%) 
Renal failure  1  2/483 (0.41%)  0/241 (0.00%) 
Ureteric obstruction  1  2/483 (0.41%)  0/241 (0.00%) 
Urinary tract obstruction  1  2/483 (0.41%)  0/241 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/483 (0.21%)  0/241 (0.00%) 
Acute respiratory distress syndrome  1  1/483 (0.21%)  0/241 (0.00%) 
Asthma  1  0/483 (0.00%)  1/241 (0.41%) 
Dyspnoea  1  6/483 (1.24%)  5/241 (2.07%) 
Dyspnoea exertional  1  1/483 (0.21%)  1/241 (0.41%) 
Hypoxia  1  1/483 (0.21%)  0/241 (0.00%) 
Pleural effusion  1  6/483 (1.24%)  3/241 (1.24%) 
Pneumothorax  1  3/483 (0.62%)  1/241 (0.41%) 
Pulmonary embolism  1  4/483 (0.83%)  1/241 (0.41%) 
Respiratory failure  1  0/483 (0.00%)  1/241 (0.41%) 
Skin and subcutaneous tissue disorders     
Rash macular  1  1/483 (0.21%)  0/241 (0.00%) 
Swelling face  1  1/483 (0.21%)  0/241 (0.00%) 
Surgical and medical procedures     
Stent placement  1  1/483 (0.21%)  0/241 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/483 (0.21%)  0/241 (0.00%) 
Embolism  1  1/483 (0.21%)  0/241 (0.00%) 
Hypertension  1  1/483 (0.21%)  0/241 (0.00%) 
Hypotension  1  2/483 (0.41%)  1/241 (0.41%) 
Ischaemia  1  1/483 (0.21%)  0/241 (0.00%) 
Shock haemorrhagic  1  1/483 (0.21%)  0/241 (0.00%) 
Superior vena cava syndrome  1  1/483 (0.21%)  0/241 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ribociclib + Fulvestrant Ribociclib Placebo + Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   473/483 (97.93%)   219/241 (90.87%) 
Blood and lymphatic system disorders     
Anaemia  1  78/483 (16.15%)  13/241 (5.39%) 
Leukopenia  1  77/483 (15.94%)  0/241 (0.00%) 
Neutropenia  1  268/483 (55.49%)  2/241 (0.83%) 
Thrombocytopenia  1  25/483 (5.18%)  4/241 (1.66%) 
Gastrointestinal disorders     
Abdominal pain  1  34/483 (7.04%)  16/241 (6.64%) 
Abdominal pain upper  1  50/483 (10.35%)  16/241 (6.64%) 
Constipation  1  117/483 (24.22%)  28/241 (11.62%) 
Diarrhoea  1  140/483 (28.99%)  49/241 (20.33%) 
Dry mouth  1  25/483 (5.18%)  3/241 (1.24%) 
Dyspepsia  1  46/483 (9.52%)  11/241 (4.56%) 
Nausea  1  215/483 (44.51%)  68/241 (28.22%) 
Stomatitis  1  48/483 (9.94%)  12/241 (4.98%) 
Vomiting  1  124/483 (25.67%)  31/241 (12.86%) 
General disorders     
Asthenia  1  68/483 (14.08%)  31/241 (12.86%) 
Fatigue  1  150/483 (31.06%)  80/241 (33.20%) 
Influenza like illness  1  24/483 (4.97%)  13/241 (5.39%) 
Oedema peripheral  1  60/483 (12.42%)  12/241 (4.98%) 
Pyrexia  1  49/483 (10.14%)  17/241 (7.05%) 
Infections and infestations     
Nasopharyngitis  1  52/483 (10.77%)  25/241 (10.37%) 
Upper respiratory tract infection  1  44/483 (9.11%)  14/241 (5.81%) 
Urinary tract infection  1  49/483 (10.14%)  22/241 (9.13%) 
Investigations     
Alanine aminotransferase increased  1  70/483 (14.49%)  11/241 (4.56%) 
Aspartate aminotransferase increased  1  63/483 (13.04%)  11/241 (4.56%) 
Blood creatinine increased  1  36/483 (7.45%)  8/241 (3.32%) 
Electrocardiogram QT prolonged  1  29/483 (6.00%)  2/241 (0.83%) 
Gamma-glutamyltransferase increased  1  33/483 (6.83%)  15/241 (6.22%) 
Neutrophil count decreased  1  89/483 (18.43%)  3/241 (1.24%) 
White blood cell count decreased  1  59/483 (12.22%)  2/241 (0.83%) 
Metabolism and nutrition disorders     
Decreased appetite  1  78/483 (16.15%)  31/241 (12.86%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  115/483 (23.81%)  64/241 (26.56%) 
Back pain  1  84/483 (17.39%)  42/241 (17.43%) 
Bone pain  1  38/483 (7.87%)  20/241 (8.30%) 
Muscle spasms  1  32/483 (6.63%)  12/241 (4.98%) 
Musculoskeletal chest pain  1  15/483 (3.11%)  17/241 (7.05%) 
Musculoskeletal pain  1  39/483 (8.07%)  32/241 (13.28%) 
Myalgia  1  37/483 (7.66%)  20/241 (8.30%) 
Neck pain  1  31/483 (6.42%)  7/241 (2.90%) 
Pain in extremity  1  65/483 (13.46%)  38/241 (15.77%) 
Nervous system disorders     
Dizziness  1  60/483 (12.42%)  19/241 (7.88%) 
Dysgeusia  1  32/483 (6.63%)  8/241 (3.32%) 
Headache  1  104/483 (21.53%)  49/241 (20.33%) 
Psychiatric disorders     
Anxiety  1  30/483 (6.21%)  12/241 (4.98%) 
Depression  1  29/483 (6.00%)  13/241 (5.39%) 
Insomnia  1  58/483 (12.01%)  26/241 (10.79%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  105/483 (21.74%)  37/241 (15.35%) 
Dyspnoea  1  68/483 (14.08%)  29/241 (12.03%) 
Oropharyngeal pain  1  28/483 (5.80%)  10/241 (4.15%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  90/483 (18.63%)  11/241 (4.56%) 
Dry skin  1  37/483 (7.66%)  5/241 (2.07%) 
Pruritus  1  96/483 (19.88%)  16/241 (6.64%) 
Rash  1  89/483 (18.43%)  14/241 (5.81%) 
Vascular disorders     
Hot flush  1  64/483 (13.25%)  41/241 (17.01%) 
Hypertension  1  48/483 (9.94%)  24/241 (9.96%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
One patient from each arm did not receive study treatment and so there two patients 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: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02422615     History of Changes
Other Study ID Numbers: CLEE011F2301
2015-000617-43 ( EudraCT Number )
First Submitted: April 1, 2015
First Posted: April 21, 2015
Results First Submitted: August 18, 2018
Results First Posted: September 19, 2018
Last Update Posted: April 16, 2019