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Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)

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: NCT02278120
Recruitment Status : Active, not recruiting
First Posted : October 29, 2014
Results First Posted : February 26, 2019
Last Update Posted : August 21, 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 Metastatic Breast Cancer
Interventions Drug: LEE011
Drug: Tamoxifen
Drug: Letrozole
Drug: Anastrozole
Drug: Goserelin
Drug: LEE011 Placebo
Enrollment 672
Recruitment Details Approximately 660 patients were planned to be randomized in a 1:1 ratio to one of the following treatment arms: Ribociclib (LEE011) arm and Placebo arm.
Pre-assignment Details  
Arm/Group Title LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Hide Arm/Group Description LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Period Title: Overall Study
Started 335 337
Completed [1] 174 121
Not Completed 161 216
Reason Not Completed
Progressive disease             122             174
Patient/guardian decision             14             8
Adverse Event             12             10
Physician Decision             8             19
Death             3             3
Lost to Follow-up             2             0
Protocol Violation             0             2
[1]
Completed = Treatment ongoing at time of data cut-off, 20-Aug-2017
Arm/Group Title LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen+ Goserelin Total
Hide Arm/Group Description LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) Total of all reporting groups
Overall Number of Baseline Participants 335 337 672
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 335 participants 337 participants 672 participants
42.6  (6.6) 43.7  (6.17) 43.1  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 335 participants 337 participants 672 participants
Female
335
 100.0%
337
 100.0%
672
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 335 participants 337 participants 672 participants
Caucasian 187 201 388
Asian 99 99 198
Black 10 9 19
Native American 3 3 6
Other 16 7 23
Unknown 20 18 38
1.Primary Outcome
Title Progression Free Survival (PFS) Per Investigator's 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 and assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1]. PFS was assessed via a local radiology assessment according to RECIST 1.1
Time Frame Up to approximatley 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).
Arm/Group Title LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Hide Arm/Group Description:
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Overall Number of Participants Analyzed 335 337
Median (95% Confidence Interval)
Unit of Measure: Months
23.8 [1] 
(19.2 to NA)
13.0
(11.0 to 16.4)
[1]
N/A = The value was not available due to insufficient number of participants with events in the treatment arm to enable estimation of the upper limit of the confidence interval.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEE011 + NSAI/Tamoxifen + Goserelin, LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio, log
Estimated Value 0.553
Confidence Interval (2-Sided) 95%
0.441 to 0.694
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 69 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Response Rate (ORR) Per Local Assessment
Hide Description ORR is the percentage of participants 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 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).
Arm/Group Title LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Hide Arm/Group Description:
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Overall Number of Participants Analyzed 335 337
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
40.9
(35.6 to 46.2)
29.7
(24.8 to 34.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEE011 + NSAI/Tamoxifen + Goserelin, LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000980
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in 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; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm.
Time Frame Up to approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).
Arm/Group Title LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Hide Arm/Group Description:
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Overall Number of Participants Analyzed 335 337
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
79.1
(74.8 to 83.5)
69.7
(64.8 to 74.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEE011 + NSAI/Tamoxifen + Goserelin, LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Safety and Tolerability of LEE011
Hide Description Safety and tolerability will be determined by type, frequency and severity of adverse events and laboratory abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame Up to approximately 26 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to Response (TTR) Per Local Investigator's Assessment
Hide Description Time to response is the time from the date of randomization to the first documented response (CR or PR, which must be confirmed subsequently) according to RECIST 1.1. All patients will be included in time to response calculations. Patients who do not achieve a confirmed response will be censored at the maximum follow-up time (i.e. first patient first visit to last patient last visit used for the analysis) for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise.
Time Frame Up to approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).
Arm/Group Title LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Hide Arm/Group Description:
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Overall Number of Participants Analyzed 335 337
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
N/A = The values were not available due to insufficient number of participants with events to enable estimation of the median as well as lower/upper limit of the confidence interval.
7.Secondary Outcome
Title Duration of Response (DOR) Per Investigator's Assessment - Patients With Confirmed Complete Response (CR) or Partial Response (PR)
Hide Description Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer
Time Frame Up to approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).
Arm/Group Title LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen+ Goserelin
Hide Arm/Group Description:
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Overall Number of Participants Analyzed 335 337
Median (95% Confidence Interval)
Unit of Measure: Months
21.3 [1] 
(18.3 to NA)
17.5 [1] 
(12.0 to NA)
[1]
NA = The value was not available due to insufficient number of participants with events to enable estimation of the upper limit of the confidence interval.
8.Secondary Outcome
Title Time to Definitive Deterioration of the ECOG PS From Baseline
Hide Description Time to deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time Frame Baseline, up to approximately 25 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Time to 10% Deterioration in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30
Hide Description Patient reported outcomes for health related quality of life
Time Frame Up to approximately 25 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30
Hide Description Patient reported outcomes for health related quality of life
Time Frame Up to approximately 25 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 randomization up to 28 days after last dose of study treatment up to 2.5 years.
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 LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen + Goserelin
Hide Arm/Group Description LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
All-Cause Mortality
LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen + Goserelin
Affected / at Risk (%) Affected / at Risk (%)
Total   5/335 (1.49%)   6/337 (1.78%) 
Show Serious Adverse Events Hide Serious Adverse Events
LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen + Goserelin
Affected / at Risk (%) Affected / at Risk (%)
Total   60/335 (17.91%)   39/337 (11.57%) 
Blood and lymphatic system disorders     
Anaemia  1  4/335 (1.19%)  0/337 (0.00%) 
Febrile neutropenia  1  3/335 (0.90%)  1/337 (0.30%) 
Neutropenia  1  1/335 (0.30%)  1/337 (0.30%) 
Cardiac disorders     
Acute myocardial infarction  1  1/335 (0.30%)  0/337 (0.00%) 
Pericardial effusion  1  0/335 (0.00%)  1/337 (0.30%) 
Sinus tachycardia  1  1/335 (0.30%)  0/337 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  5/335 (1.49%)  0/337 (0.00%) 
Ascites  1  1/335 (0.30%)  0/337 (0.00%) 
Diarrhoea  1  2/335 (0.60%)  2/337 (0.59%) 
Dysphagia  1  1/335 (0.30%)  0/337 (0.00%) 
Enterocolitis  1  1/335 (0.30%)  0/337 (0.00%) 
Ileus  1  1/335 (0.30%)  0/337 (0.00%) 
Nausea  1  2/335 (0.60%)  2/337 (0.59%) 
Stomatitis  1  1/335 (0.30%)  1/337 (0.30%) 
Subileus  1  1/335 (0.30%)  0/337 (0.00%) 
Vomiting  1  3/335 (0.90%)  2/337 (0.59%) 
General disorders     
Axillary pain  1  1/335 (0.30%)  0/337 (0.00%) 
Fatigue  1  1/335 (0.30%)  0/337 (0.00%) 
Pyrexia  1  3/335 (0.90%)  2/337 (0.59%) 
Hepatobiliary disorders     
Cholecystitis  1  0/335 (0.00%)  1/337 (0.30%) 
Cholelithiasis  1  1/335 (0.30%)  1/337 (0.30%) 
Drug-induced liver injury  1  4/335 (1.19%)  1/337 (0.30%) 
Hepatic haemorrhage  1  0/335 (0.00%)  1/337 (0.30%) 
Hepatotoxicity  1  0/335 (0.00%)  1/337 (0.30%) 
Hyperbilirubinaemia  1  0/335 (0.00%)  1/337 (0.30%) 
Immune system disorders     
Hypersensitivity  1  0/335 (0.00%)  1/337 (0.30%) 
Infections and infestations     
Acute sinusitis  1  1/335 (0.30%)  0/337 (0.00%) 
Bacteraemia  1  0/335 (0.00%)  2/337 (0.59%) 
Cellulitis  1  1/335 (0.30%)  0/337 (0.00%) 
Device related infection  1  1/335 (0.30%)  0/337 (0.00%) 
Gastroenteritis  1  2/335 (0.60%)  0/337 (0.00%) 
Gastroenteritis viral  1  0/335 (0.00%)  1/337 (0.30%) 
Influenza  1  1/335 (0.30%)  1/337 (0.30%) 
Lung infection  1  2/335 (0.60%)  0/337 (0.00%) 
Pneumonia  1  0/335 (0.00%)  1/337 (0.30%) 
Pyelonephritis  1  1/335 (0.30%)  0/337 (0.00%) 
Pyelonephritis acute  1  1/335 (0.30%)  0/337 (0.00%) 
Sepsis  1  1/335 (0.30%)  0/337 (0.00%) 
Upper respiratory tract infection  1  1/335 (0.30%)  0/337 (0.00%) 
Viral infection  1  1/335 (0.30%)  0/337 (0.00%) 
Wound infection  1  1/335 (0.30%)  0/337 (0.00%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/335 (0.30%)  0/337 (0.00%) 
Femur fracture  1  1/335 (0.30%)  2/337 (0.59%) 
Humerus fracture  1  0/335 (0.00%)  1/337 (0.30%) 
Meniscus injury  1  0/335 (0.00%)  1/337 (0.30%) 
Spinal fracture  1  1/335 (0.30%)  0/337 (0.00%) 
Wound haemorrhage  1  1/335 (0.30%)  0/337 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/335 (0.30%)  2/337 (0.59%) 
Aspartate aminotransferase increased  1  1/335 (0.30%)  2/337 (0.59%) 
Blood alkaline phosphatase increased  1  0/335 (0.00%)  1/337 (0.30%) 
Gamma-glutamyltransferase increased  1  1/335 (0.30%)  1/337 (0.30%) 
Hepatic enzyme increased  1  1/335 (0.30%)  0/337 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/335 (0.30%)  0/337 (0.00%) 
Electrolyte imbalance  1  1/335 (0.30%)  0/337 (0.00%) 
Hypercalcaemia  1  0/335 (0.00%)  2/337 (0.59%) 
Hyperglycaemia  1  1/335 (0.30%)  0/337 (0.00%) 
Hypoalbuminaemia  1  1/335 (0.30%)  0/337 (0.00%) 
Hypocalcaemia  1  1/335 (0.30%)  0/337 (0.00%) 
Hypokalaemia  1  0/335 (0.00%)  1/337 (0.30%) 
Lactic acidosis  1  1/335 (0.30%)  0/337 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/335 (1.19%)  1/337 (0.30%) 
Bone pain  1  1/335 (0.30%)  1/337 (0.30%) 
Intervertebral disc protrusion  1  1/335 (0.30%)  0/337 (0.00%) 
Musculoskeletal chest pain  1  0/335 (0.00%)  1/337 (0.30%) 
Myositis  1  0/335 (0.00%)  1/337 (0.30%) 
Neck pain  1  0/335 (0.00%)  1/337 (0.30%) 
Osteoarthritis  1  1/335 (0.30%)  0/337 (0.00%) 
Osteonecrosis  1  1/335 (0.30%)  0/337 (0.00%) 
Pathological fracture  1  1/335 (0.30%)  1/337 (0.30%) 
Rhabdomyolysis  1  0/335 (0.00%)  1/337 (0.30%) 
Spinal pain  1  1/335 (0.30%)  0/337 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  0/335 (0.00%)  1/337 (0.30%) 
Chronic myeloid leukaemia  1  0/335 (0.00%)  1/337 (0.30%) 
Intracranial tumour haemorrhage  1  1/335 (0.30%)  0/337 (0.00%) 
Lipoma  1  0/335 (0.00%)  1/337 (0.30%) 
Malignant pleural effusion  1  1/335 (0.30%)  0/337 (0.00%) 
Metastases to central nervous system  1  0/335 (0.00%)  1/337 (0.30%) 
Metastases to meninges  1  0/335 (0.00%)  2/337 (0.59%) 
Nervous system disorders     
Cerebral infarction  1  1/335 (0.30%)  0/337 (0.00%) 
Dizziness  1  1/335 (0.30%)  0/337 (0.00%) 
Haemorrhage intracranial  1  1/335 (0.30%)  0/337 (0.00%) 
Headache  1  1/335 (0.30%)  1/337 (0.30%) 
Hydrocephalus  1  1/335 (0.30%)  0/337 (0.00%) 
Superior sagittal sinus thrombosis  1  1/335 (0.30%)  0/337 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/335 (0.30%)  0/337 (0.00%) 
Obsessive-compulsive disorder  1  0/335 (0.00%)  1/337 (0.30%) 
Renal and urinary disorders     
Haematuria  1  1/335 (0.30%)  0/337 (0.00%) 
Renal failure  1  0/335 (0.00%)  2/337 (0.59%) 
Reproductive system and breast disorders     
Pelvic pain  1  0/335 (0.00%)  1/337 (0.30%) 
Vaginal haemorrhage  1  0/335 (0.00%)  1/337 (0.30%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/335 (0.30%)  0/337 (0.00%) 
Dyspnoea  1  5/335 (1.49%)  2/337 (0.59%) 
Hydrothorax  1  1/335 (0.30%)  0/337 (0.00%) 
Pleural effusion  1  6/335 (1.79%)  4/337 (1.19%) 
Pulmonary embolism  1  2/335 (0.60%)  1/337 (0.30%) 
Respiratory failure  1  1/335 (0.30%)  1/337 (0.30%) 
Sinusitis noninfective  1  1/335 (0.30%)  0/337 (0.00%) 
Vascular disorders     
Hypovolaemic shock  1  1/335 (0.30%)  0/337 (0.00%) 
Superior vena cava syndrome  1  1/335 (0.30%)  0/337 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
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%
LEE011 + NSAI/Tamoxifen + Goserelin LEE011 Placebo + NSAI/Tamoxifen + Goserelin
Affected / at Risk (%) Affected / at Risk (%)
Total   324/335 (96.72%)   304/337 (90.21%) 
Blood and lymphatic system disorders     
Anaemia  1  64/335 (19.10%)  32/337 (9.50%) 
Leukopenia  1  55/335 (16.42%)  11/337 (3.26%) 
Lymphopenia  1  19/335 (5.67%)  4/337 (1.19%) 
Neutropenia  1  182/335 (54.33%)  18/337 (5.34%) 
Thrombocytopenia  1  19/335 (5.67%)  5/337 (1.48%) 
Gastrointestinal disorders     
Abdominal pain  1  32/335 (9.55%)  24/337 (7.12%) 
Abdominal pain upper  1  16/335 (4.78%)  21/337 (6.23%) 
Constipation  1  55/335 (16.42%)  42/337 (12.46%) 
Diarrhoea  1  66/335 (19.70%)  62/337 (18.40%) 
Nausea  1  105/335 (31.34%)  65/337 (19.29%) 
Stomatitis  1  34/335 (10.15%)  26/337 (7.72%) 
Vomiting  1  63/335 (18.81%)  55/337 (16.32%) 
General disorders     
Asthenia  1  43/335 (12.84%)  41/337 (12.17%) 
Fatigue  1  78/335 (23.28%)  83/337 (24.63%) 
Non-cardiac chest pain  1  18/335 (5.37%)  8/337 (2.37%) 
Oedema peripheral  1  19/335 (5.67%)  17/337 (5.04%) 
Pyrexia  1  49/335 (14.63%)  25/337 (7.42%) 
Infections and infestations     
Influenza  1  16/335 (4.78%)  21/337 (6.23%) 
Upper respiratory tract infection  1  37/335 (11.04%)  30/337 (8.90%) 
Urinary tract infection  1  30/335 (8.96%)  27/337 (8.01%) 
Viral upper respiratory tract infection  1  19/335 (5.67%)  12/337 (3.56%) 
Investigations     
Alanine aminotransferase increased  1  43/335 (12.84%)  24/337 (7.12%) 
Aspartate aminotransferase increased  1  40/335 (11.94%)  30/337 (8.90%) 
Electrocardiogram QT prolonged  1  37/335 (11.04%)  16/337 (4.75%) 
Gamma-glutamyltransferase increased  1  17/335 (5.07%)  25/337 (7.42%) 
Neutrophil count decreased  1  107/335 (31.94%)  5/337 (1.48%) 
White blood cell count decreased  1  46/335 (13.73%)  4/337 (1.19%) 
Metabolism and nutrition disorders     
Decreased appetite  1  30/335 (8.96%)  27/337 (8.01%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  100/335 (29.85%)  92/337 (27.30%) 
Back pain  1  58/335 (17.31%)  65/337 (19.29%) 
Bone pain  1  26/335 (7.76%)  31/337 (9.20%) 
Musculoskeletal chest pain  1  9/335 (2.69%)  17/337 (5.04%) 
Musculoskeletal pain  1  30/335 (8.96%)  36/337 (10.68%) 
Myalgia  1  34/335 (10.15%)  37/337 (10.98%) 
Pain in extremity  1  34/335 (10.15%)  34/337 (10.09%) 
Nervous system disorders     
Dizziness  1  22/335 (6.57%)  19/337 (5.64%) 
Headache  1  77/335 (22.99%)  82/337 (24.33%) 
Psychiatric disorders     
Depression  1  21/335 (6.27%)  20/337 (5.93%) 
Insomnia  1  42/335 (12.54%)  46/337 (13.65%) 
Reproductive system and breast disorders     
Breast pain  1  18/335 (5.37%)  20/337 (5.93%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  50/335 (14.93%)  39/337 (11.57%) 
Dyspnoea  1  19/335 (5.67%)  17/337 (5.04%) 
Oropharyngeal pain  1  26/335 (7.76%)  12/337 (3.56%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  63/335 (18.81%)  39/337 (11.57%) 
Dry skin  1  27/335 (8.06%)  7/337 (2.08%) 
Pruritus  1  31/335 (9.25%)  13/337 (3.86%) 
Rash  1  44/335 (13.13%)  29/337 (8.61%) 
Vascular disorders     
Hot flush  1  114/335 (34.03%)  113/337 (33.53%) 
Hypertension  1  29/335 (8.66%)  23/337 (6.82%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02278120     History of Changes
Other Study ID Numbers: CLEE011E2301
2014-001931-36 ( EudraCT Number )
First Submitted: October 22, 2014
First Posted: October 29, 2014
Results First Submitted: August 17, 2018
Results First Posted: February 26, 2019
Last Update Posted: August 21, 2019