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E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00388726
Recruitment Status : Completed
First Posted : October 17, 2006
Results First Posted : January 30, 2012
Last Update Posted : July 31, 2014
Sponsor:
Collaborator:
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: E7389
Drug: Physician's Choice
Enrollment 762
Recruitment Details This study was recruited at 135 centers in 19 countries during the period of Nov 2006 to May 2009.
Pre-assignment Details  
Arm/Group Title Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Hide Arm/Group Description Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8 Treatment of Physician's Choice
Period Title: Overall Study
Started 508 254
Completed 24 10
Not Completed 484 244
Reason Not Completed
Adverse Event             50             24
Progressive Disease             336             153
Clinical Progression             61             36
Withdrawal by Subject             10             7
Administrative             6             9
Physician Decision             18             13
Death             3             2
Arm/Group Title Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice Total
Hide Arm/Group Description Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8 Treatment of Physician's Choice Total of all reporting groups
Overall Number of Baseline Participants 508 254 762
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 508 participants 254 participants 762 participants
54.8  (10.34) 55.9  (10.43) 55.2  (10.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 508 participants 254 participants 762 participants
Female
508
 100.0%
254
 100.0%
762
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 508 participants 254 participants 762 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   0.6%
2
   0.8%
5
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
   3.9%
14
   5.5%
34
   4.5%
White
470
  92.5%
233
  91.7%
703
  92.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
15
   3.0%
5
   2.0%
20
   2.6%
1.Primary Outcome
Title Overall Survival
Hide Description Defined as the time from the date of randomization until the date of death from any cause.
Time Frame From date of randomization until death from any cause
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Hide Arm/Group Description:
Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
Treatment of Physician's Choice
Overall Number of Participants Analyzed 508 254
Median (Full Range)
Unit of Measure: Days
399
(360 to 434)
324
(282 to 380)
2.Secondary Outcome
Title Progression-Free Survival.
Hide Description Measured using Response Evaluation Criteria in Solid Tumors (RECIST) and defined as the time from the date of randomization until progressive disease or death from any cause in the absence of of progressive disease.
Time Frame Until disease progression or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Hide Arm/Group Description:
Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
Treatment of Physician's Choice
Overall Number of Participants Analyzed 508 254
Median (Full Range)
Unit of Measure: Days
113
(101 to 118)
68
(63 to 103)
3.Secondary Outcome
Title Best Overall Response
Hide Description Measured by RECIST criteria and defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Time Frame Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.
Hide Outcome Measure Data
Hide Analysis Population Description
Response Evaluable Population
Arm/Group Title Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Hide Arm/Group Description:
Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
Treatment of Physician's Choice
Overall Number of Participants Analyzed 468 214
Measure Type: Number
Unit of Measure: Percent of Participants
Objective Response Rate (CR+PR) 12.2 4.7
Complete Response 0.6 0
Partial Response 11.5 4.7
Stable Disease 44.4 44.9
Progressive Disease 40.6 49.1
Not Evaluable 2.6 1.4
Unknown 0.2 0
4.Secondary Outcome
Title Duration of Response.
Hide Description As measured by RECIST criteria and defined as the time from the first documented CR or PR until disease progression or death from any cause.
Time Frame From first documented CR or PR until disease progression or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Response Evaluable Population
Arm/Group Title Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Hide Arm/Group Description:
Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
Treatment of Physician's Choice
Overall Number of Participants Analyzed 468 214
Median (Full Range)
Unit of Measure: Days
128
(116 to 152)
205
(205 to 212)
5.Secondary Outcome
Title Safety Parameters: Adverse Events (AEs), Laboratory Parameters, Concomitant Medication, Electrocardiograms (ECGs), and Study Drug Exposure.
Hide Description [Not Specified]
Time Frame AEs and conmeds – until study termination; lab tests – Day 1 and weekly until study termination; ECGs - Day 1 and at study termination.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Hide Arm/Group Description Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8 Treatment of Physician's Choice
All-Cause Mortality
Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Affected / at Risk (%) Affected / at Risk (%)
Total   126/503 (25.05%)   64/247 (25.91%) 
Blood and lymphatic system disorders     
Febrile Neutropenia  21/503 (4.17%)  3/247 (1.21%) 
Neutropenia  9/503 (1.79%)  0/247 (0.00%) 
Anemia  1/503 (0.20%)  2/247 (0.81%) 
Pancytopenia  1/503 (0.20%)  0/247 (0.00%) 
Cardiac disorders     
Pericardial Effusion  2/503 (0.40%)  0/247 (0.00%) 
Cardiac Failure  1/503 (0.20%)  0/247 (0.00%) 
Extrasystoles  0/503 (0.00%)  1/247 (0.40%) 
Gastrointestinal disorders     
Nausea  7/503 (1.39%)  2/247 (0.81%) 
Vomiting  5/503 (0.99%)  1/247 (0.40%) 
Diarrhea  1/503 (0.20%)  4/247 (1.62%) 
Abdominal Pain  1/503 (0.20%)  3/247 (1.21%) 
Ascites  1/503 (0.20%)  2/247 (0.81%) 
Constipation  1/503 (0.20%)  1/247 (0.40%) 
Stomatitis  2/503 (0.40%)  0/247 (0.00%) 
Abdominal Distention  0/503 (0.00%)  1/247 (0.40%) 
Abdominal Pain Upper  0/503 (0.00%)  1/247 (0.40%) 
Colonic Obstruction  1/503 (0.20%)  0/247 (0.00%) 
Intestinal Obstruction  1/503 (0.20%)  0/247 (0.00%) 
Melena  0/503 (0.00%)  1/247 (0.40%) 
Mouth Hemorrhage  1/503 (0.20%)  0/247 (0.00%) 
Esophageal Stenosis  1/503 (0.20%)  0/247 (0.00%) 
Esophageal Varices Hemorrhage  1/503 (0.20%)  0/247 (0.00%) 
Pancreatitis  1/503 (0.20%)  0/247 (0.00%) 
Rectal Hemorrhage  1/503 (0.20%)  0/247 (0.00%) 
General disorders     
Asthenia/Fatigue  7/503 (1.39%)  6/247 (2.43%) 
Asthenia  6/503 (1.19%)  5/247 (2.02%) 
Pyrexia  7/503 (1.39%)  2/247 (0.81%) 
General Physical Health Deterioration  6/503 (1.19%)  2/247 (0.81%) 
Pain  1/503 (0.20%)  2/247 (0.81%) 
Performance Status Decreased  0/503 (0.00%)  3/247 (1.21%) 
Fatigue  1/503 (0.20%)  1/247 (0.40%) 
Mucosal Inflammation  1/503 (0.20%)  1/247 (0.40%) 
Chills  1/503 (0.20%)  0/247 (0.00%) 
Non-Cardiac Chest Pain  1/503 (0.20%)  0/247 (0.00%) 
Hepatobiliary disorders     
Bile Duct Obstruction  1/503 (0.20%)  0/247 (0.00%) 
Cytolytic Hepatitis  1/503 (0.20%)  0/247 (0.00%) 
Hepatic Failure  0/503 (0.00%)  1/247 (0.40%) 
Hyperbilirubinemia  0/503 (0.00%)  1/247 (0.40%) 
Infections and infestations     
Pneumonia  4/503 (0.80%)  1/247 (0.40%) 
Erisipelas  2/503 (0.40%)  1/247 (0.40%) 
Catheter Related Infection  2/503 (0.40%)  0/247 (0.00%) 
Cellulitis  1/503 (0.20%)  1/247 (0.40%) 
Lung Infection  2/503 (0.40%)  0/247 (0.00%) 
Urinary Tract Infection  2/503 (0.40%)  0/247 (0.00%) 
Aspergillosis  0/503 (0.00%)  1/247 (0.40%) 
Breast Cellulitis  1/503 (0.20%)  0/247 (0.00%) 
Bronchopneumonia  1/503 (0.20%)  0/247 (0.00%) 
Catheter Site Infection  1/503 (0.20%)  0/247 (0.00%) 
Central Line Infection  1/503 (0.20%)  0/247 (0.00%) 
Clostridium Difficile Colitis  1/503 (0.20%)  0/247 (0.00%) 
Herpes Zoster  1/503 (0.20%)  0/247 (0.00%) 
Lower Respiratory Tract Infection  0/503 (0.00%)  1/247 (0.40%) 
Neutropenic Sepsis  1/503 (0.20%)  0/247 (0.00%) 
Parotitis  1/503 (0.20%)  0/247 (0.00%) 
Respiratory Tract Infection  0/503 (0.00%)  1/247 (0.40%) 
Sepsis  1/503 (0.20%)  0/247 (0.00%) 
Septic Shock  1/503 (0.20%)  0/247 (0.00%) 
Staphylococcal Sepsis  0/503 (0.00%)  1/247 (0.40%) 
Viral Infection  1/503 (0.20%)  0/247 (0.00%) 
Injury, poisoning and procedural complications     
Hip Fracture  1/503 (0.20%)  1/247 (0.40%) 
Humerus Fracture  1/503 (0.20%)  1/247 (0.40%) 
Compression Fracture  0/503 (0.00%)  1/247 (0.40%) 
Fall  1/503 (0.20%)  0/247 (0.00%) 
Femur Fracture  1/503 (0.20%)  0/247 (0.00%) 
Investigations     
Body Temperature Increased  2/503 (0.40%)  1/247 (0.40%) 
Blood Creatinine Increased  1/503 (0.20%)  0/247 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcemia  7/503 (1.39%)  2/247 (0.81%) 
Dehydration  3/503 (0.60%)  2/247 (0.81%) 
Anorexia  0/503 (0.00%)  1/247 (0.40%) 
Diabetic Ketoacidosis  1/503 (0.20%)  0/247 (0.00%) 
Hyperglycemia  1/503 (0.20%)  0/247 (0.00%) 
Hypoglycemia  0/503 (0.00%)  0/247 (0.00%) 
Hypovolemia  1/503 (0.20%)  0/247 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  4/503 (0.80%)  3/247 (1.21%) 
Bone Pain  3/503 (0.60%)  0/247 (0.00%) 
Muscular Weakness  2/503 (0.40%)  0/247 (0.00%) 
Musculoskeletal Pain  2/503 (0.40%)  0/247 (0.00%) 
Arthralgia  0/503 (0.00%)  1/247 (0.40%) 
Arthralgia/Myalgia  0/503 (0.00%)  1/247 (0.40%) 
Fistula  1/503 (0.20%)  0/247 (0.00%) 
Osteonecrosis  1/503 (0.20%)  0/247 (0.00%) 
Pain in Extremity  0/503 (0.00%)  1/247 (0.40%) 
Pathological Fracture  1/503 (0.20%)  0/247 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant Neoplasm Progression  4/503 (0.80%)  2/247 (0.81%) 
Metastases to Meninges  3/503 (0.60%)  0/247 (0.00%) 
Cancer Pain  0/503 (0.00%)  2/247 (0.81%) 
Brain Cancer  0/503 (0.00%)  1/247 (0.40%) 
Metastatic Hepatic Neoplasm  0/503 (0.00%)  1/247 (0.40%) 
Metastases to Bone  1/503 (0.20%)  0/247 (0.00%) 
Ovarian Neoplasm  1/503 (0.20%)  0/247 (0.00%) 
Nervous system disorders     
Peripheral Neuropathy  3/503 (0.60%)  2/247 (0.81%) 
Headache  1/503 (0.20%)  2/247 (0.81%) 
Dizziness  1/503 (0.20%)  1/247 (0.40%) 
Epilepsy  2/503 (0.40%)  0/247 (0.00%) 
Lethargy  2/503 (0.40%)  0/247 (0.00%) 
Neuropathy Peripheral  1/503 (0.20%)  1/247 (0.40%) 
Peripheral Motor Neuropathy  1/503 (0.20%)  1/247 (0.40%) 
Convulsion  1/503 (0.20%)  0/247 (0.00%) 
Epiduritis  1/503 (0.20%)  0/247 (0.00%) 
Memory Impairment  1/503 (0.20%)  0/247 (0.00%) 
Paraesthesia  1/503 (0.20%)  0/247 (0.00%) 
Paraparesis  1/503 (0.20%)  0/247 (0.00%) 
Vocal Cord Paralysis  0/503 (0.00%)  1/247 (0.40%) 
Psychiatric disorders     
Confusional State  2/503 (0.40%)  1/247 (0.40%) 
Anxiety  1/503 (0.20%)  0/247 (0.00%) 
Mental Status Changes  1/503 (0.20%)  0/247 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute  1/503 (0.20%)  2/247 (0.81%) 
Hematuria  0/503 (0.00%)  1/247 (0.40%) 
Obstructive Uropathy  1/503 (0.20%)  0/247 (0.00%) 
Reproductive system and breast disorders     
Ovarian Mass  1/503 (0.20%)  0/247 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  7/503 (1.39%)  9/247 (3.64%) 
Pleural Effusion  6/503 (1.19%)  4/247 (1.62%) 
Pulmonary Embolism  7/503 (1.39%)  3/247 (1.21%) 
Respiratory Failure  1/503 (0.20%)  2/247 (0.81%) 
Atelectasis  0/503 (0.00%)  1/247 (0.40%) 
Cough  1/503 (0.20%)  0/247 (0.00%) 
Interstitial Lung Disease  0/503 (0.00%)  1/247 (0.40%) 
Pharyngolaryngeal Pain  1/503 (0.20%)  0/247 (0.00%) 
Pneumonitis  0/503 (0.00%)  1/247 (0.40%) 
Productive Cough  1/503 (0.20%)  0/247 (0.00%) 
Pulmonary Artery Thrombosis  1/503 (0.20%)  0/247 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar-Plantar Erythrodysaethesia Syndrome  1/503 (0.20%)  1/247 (0.40%) 
Rash  1/503 (0.20%)  1/247 (0.40%) 
Angioedema  1/503 (0.20%)  0/247 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis  2/503 (0.40%)  2/247 (0.81%) 
Cardiovascular Insufficiency  1/503 (0.20%)  1/247 (0.40%) 
Embolism  1/503 (0.20%)  1/247 (0.40%) 
Hypotension  1/503 (0.20%)  0/247 (0.00%) 
Venous Thrombosis  1/503 (0.20%)  0/247 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eribulin Mesylate 1.4 mg/kg^2 Treatment of Physician's Choice
Affected / at Risk (%) Affected / at Risk (%)
Total   497/503 (98.81%)   230/247 (93.12%) 
Blood and lymphatic system disorders     
Neutropenia  264/503 (52.49%)  74/247 (29.96%) 
Anemia  97/503 (19.28%)  56/247 (22.67%) 
Leukopenia  118/503 (23.46%)  28/247 (11.34%) 
Eye disorders     
Lacrimation Decreased  35/503 (6.96%)  8/247 (3.24%) 
Gastrointestinal disorders     
Nausea  175/503 (34.79%)  70/247 (28.34%) 
Constipation  124/503 (24.65%)  51/247 (20.65%) 
Diarrhea  96/503 (19.09%)  45/247 (18.22%) 
Vomiting  94/503 (18.69%)  44/247 (17.81%) 
Abdominal Pain Upper  46/503 (9.15%)  15/247 (6.07%) 
Abdominal Pain  39/503 (7.75%)  20/247 (8.10%) 
Dyspepsia  42/503 (8.35%)  8/247 (3.24%) 
Stomatitis  38/503 (7.55%)  12/247 (4.86%) 
Dry Mouth  29/503 (5.77%)  3/247 (1.21%) 
General disorders     
Asthenia/Fatigue  273/503 (54.27%)  99/247 (40.08%) 
Asthenia  138/503 (27.44%)  59/247 (23.89%) 
Fatigue  148/503 (29.42%)  47/247 (19.03%) 
Pyrexia  107/503 (21.27%)  31/247 (12.55%) 
Mucosal Inflammation  44/503 (8.75%)  25/247 (10.12%) 
Peripheral Edema  46/503 (9.15%)  21/247 (8.50%) 
Pain  24/503 (4.77%)  16/247 (6.48%) 
Infections and infestations     
Urinary Tract Infection  49/503 (9.74%)  13/247 (5.26%) 
Upper Respiratory Tract Infection  27/503 (5.37%)  5/247 (2.02%) 
Investigations     
Weight Decreased  107/503 (21.27%)  36/247 (14.57%) 
Alanine Aminotransferase Increased  27/503 (5.37%)  6/247 (2.43%) 
Metabolism and nutrition disorders     
Anorexia  101/503 (20.08%)  32/247 (12.96%) 
Hypokalemia  36/503 (7.16%)  5/247 (2.02%) 
Musculoskeletal and connective tissue disorders     
Arthralgia/Myalgia  112/503 (22.27%)  29/247 (11.74%) 
Back Pain  81/503 (16.10%)  18/247 (7.29%) 
Arthralgia  73/503 (14.51%)  13/247 (5.26%) 
Bone Pain  61/503 (12.13%)  23/247 (9.31%) 
Pain in Extremity  58/503 (11.53%)  25/247 (10.12%) 
Myalgia  54/503 (10.74%)  17/247 (6.88%) 
Musculoskeletal Chest Pain  37/503 (7.36%)  15/247 (6.07%) 
Musculoskeletal Pain  38/503 (7.55%)  11/247 (4.45%) 
Muscle Spasms  38/503 (7.55%)  10/247 (4.05%) 
Muscular Weakness  27/503 (5.37%)  3/247 (1.21%) 
Nervous system disorders     
Peripheral Neuropathy  174/503 (34.59%)  40/247 (16.19%) 
Headache  98/503 (19.48%)  29/247 (11.74%) 
Paresthesia  56/503 (11.13%)  16/247 (6.48%) 
Peripheral Sensory Neuropathy  62/503 (12.33%)  10/247 (4.05%) 
Dizziness  38/503 (7.55%)  14/247 (5.67%) 
Neuropathy Peripheral  39/503 (7.75%)  9/247 (3.64%) 
Dysgeusia  40/503 (7.95%)  5/247 (2.02%) 
Psychiatric disorders     
Insomnia  38/503 (7.55%)  10/247 (4.05%) 
Anxiety  27/503 (5.37%)  11/247 (4.45%) 
Depression  27/503 (5.37%)  3/247 (1.21%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  79/503 (15.71%)  31/247 (12.55%) 
Cough  74/503 (14.71%)  21/247 (8.50%) 
Pharyngolaryngeal Pain  36/503 (7.16%)  3/247 (1.21%) 
Epistaxis  12/503 (2.39%)  13/247 (5.26%) 
Skin and subcutaneous tissue disorders     
Alopecia  225/503 (44.73%)  24/247 (9.72%) 
Rash  32/503 (6.36%)  15/247 (6.07%) 
Palmar-Plantar Erythrodysaesthesia Syndrome  7/503 (1.39%)  34/247 (13.77%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Peter Tarassoff
Organization: Eisai
Phone: 888-422-4743
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00388726     History of Changes
Other Study ID Numbers: E7389-G000-305
2006-001949-34 ( EudraCT Number )
First Submitted: October 13, 2006
First Posted: October 17, 2006
Results First Submitted: December 22, 2011
Results First Posted: January 30, 2012
Last Update Posted: July 31, 2014