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Trial record 91 of 157 for:    eribulin

Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive 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: NCT01269346
Recruitment Status : Completed
First Posted : January 4, 2011
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Eribulin Mesylate
Enrollment 52
Recruitment Details  
Pre-assignment Details A total of 64 participants were screened for entry into the study, of these participants 12 were screen failures and 52 were enrolled into the study and received at least one dose of study treatment.
Arm/Group Title Eribulin Mesylate in Combination With Trastuzumab
Hide Arm/Group Description

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as an IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Period Title: Treatment Phase
Started 52
Completed 6 Cycles 45
Completed 43
Not Completed 9
Reason Not Completed
Disease progression             3
Adverse Event             3
Withdrawal by Subject             1
Not specified             2
Period Title: Extension Phase
Started 43 [1]
Completed 0
Not Completed 43
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             4
Disease progression             22
Physician decision or participant choice             9
Clinical progression             1
Started a prohibited con med             1
[1]
Out of 52 participants randomized, only 43 continued into the Extension Phase of the study.
Arm/Group Title Eribulin Mesylate in Combination With Trastuzumab
Hide Arm/Group Description

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who received at least one dose of study drug.
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants
58.7  (10.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
51
  98.1%
Male
1
   1.9%
1.Primary Outcome
Title Objective Response Rate
Hide Description The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant’s overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.
Time Frame Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of study drug.
Arm/Group Title Eribulin Mesylate in Combination With Trastuzumab
Hide Arm/Group Description:

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
71.2
(56.92 to 82.87)
2.Secondary Outcome
Title Time to First Response
Hide Description Time to first response was defined for participants whose best overall response was a CR or PR.
Time Frame From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of study drug. Analyzed for responders (CR or PR) only.
Arm/Group Title Eribulin Mesylate in Combination With Trastuzumab
Hide Arm/Group Description:

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: Months
1.3
(1.22 to 1.38)
3.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Duration of response was defined for participants whose best overall response was CR or PR. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were alive at the end of the study without reported PD were censored on the date of their last tumor assessment.
Time Frame Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of study drug. Analyzed for responders only (n = 37).
Arm/Group Title Eribulin Mesylate in Combination With Trastuzumab
Hide Arm/Group Description:

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: Months
11.1
(6.70 to 17.77)
4.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment.
Time Frame Date of first dose of study drug to date of PD or death (from any cause) whichever came first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of study drug.
Arm/Group Title Eribulin Mesylate in Combination With Trastuzumab
Hide Arm/Group Description:

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Overall Number of Participants Analyzed 52
Median (95% Confidence Interval)
Unit of Measure: Months
11.6
(9.13 to 13.93)
5.Secondary Outcome
Title Duration of Stable Disease (SD)
Hide Description Defined as the period from treatment start date to the date of PD or death, whichever occurred first. Participants who were alive without having PD as of the data cutoff date were censored as of their last tumor assessment. Calculated for participants who best response was SD.
Time Frame Start of study treatment to date of PD or death, whichever occurred first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of study drug.
Arm/Group Title Eribulin Mesylate in Combination With Trastuzumab
Hide Arm/Group Description:

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Overall Number of Participants Analyzed 13
Median (95% Confidence Interval)
Unit of Measure: Months
7.1
(5.55 to 13.50)
Time Frame From the date of signed informed consent until 30 days after discontinuation of study drug or until resolution, whichever occurred first. Up to approximately 2 years 10 months.
Adverse Event Reporting Description Treatment-emergent adverse events and serious adverse events were reported. Safety Set included all participants who received at least one dose of study drug and had at least one postbaseline safety assessment. Study treatment toxicities were graded on a 5-point scale in accordance with Common Terminology Criteria for Adverse Events, version 4.0.
 
Arm/Group Title Eribulin Mesylate in Combination With Trastuzumab
Hide Arm/Group Description

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

All-Cause Mortality
Eribulin Mesylate in Combination With Trastuzumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin Mesylate in Combination With Trastuzumab
Affected / at Risk (%)
Total   15/52 (28.85%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/52 (1.92%) 
Febrile neutropenia  2  4/52 (7.69%) 
Neutropenia  2  8/52 (15.38%) 
Cardiac disorders   
Cardiac failure chronic  2  1/52 (1.92%) 
Gastrointestinal disorders   
Vomiting  2  3/52 (5.77%) 
Diarrhoea  2  1/52 (1.92%) 
Gastric ulcer  2  1/52 (1.92%) 
Gastritis  2  1/52 (1.92%) 
Nausea  2  1/52 (1.92%) 
General disorders   
Fatigue  2  1/52 (1.92%) 
Pyrexia  2  1/52 (1.92%) 
Infections and infestations   
Gastroenteritis  2  1/52 (1.92%) 
Lobar pneumonia  2  1/52 (1.92%) 
Urinary tract infection  2  1/52 (1.92%) 
Investigations   
Electrocardiogram T wave abnormal  2  1/52 (1.92%) 
White blood cell count decreased  2  1/52 (1.92%) 
Metabolism and nutrition disorders   
Failure to thrive  2  1/52 (1.92%) 
Hypercalcaemia  2  1/52 (1.92%) 
Hyperglycaemia  2  1/52 (1.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cholangiocarcinoma  2  1/52 (1.92%) 
Nervous system disorders   
Headache  2  1/52 (1.92%) 
Neuropathy peripheral  2  3/52 (5.77%) 
Peripheral sensory neuropathy  2  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  2  1/52 (1.92%) 
Surgical and medical procedures   
Modified radical mastectomy  2  1/52 (1.92%) 
Vascular disorders   
Orthostatic hypotension  2  1/52 (1.92%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 16.0
2
Term from vocabulary, Select
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eribulin Mesylate in Combination With Trastuzumab
Affected / at Risk (%)
Total   52/52 (100.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  13/52 (25.00%) 
Febrile neutropenia  2  4/52 (7.69%) 
Leukocytosis  2  1/52 (1.92%) 
Leukopenia  2  9/52 (17.31%) 
Lymphadenopathy  2  1/52 (1.92%) 
Neutropenia  2  31/52 (59.62%) 
Normochromic normocytic anaemia  2  1/52 (1.92%) 
Thrombocytopenia * 1  1/52 (1.92%) 
Cardiac disorders   
Bundle branch block right  2  1/52 (1.92%) 
Cardiac failure chronic  2  1/52 (1.92%) 
Electrocardiogram QT prolonged  2  3/52 (5.77%) 
Palpitations  2  1/52 (1.92%) 
Pericardial effusion  2  1/52 (1.92%) 
Sinus tachycardia  2  1/52 (1.92%) 
Tachycardia  2  1/52 (1.92%) 
Ear and labyrinth disorders   
Ear discomfort  2  2/52 (3.85%) 
Ear Pain  2  1/52 (1.92%) 
External ear inflammation  2  1/52 (1.92%) 
Vertigo * 1  1/52 (1.92%) 
Eye disorders   
Cataract * 1  3/52 (5.77%) 
Dacryostenosis acquired  2  1/52 (1.92%) 
Dry eye  2  3/52 (5.77%) 
Eye allergy  2  2/52 (3.85%) 
Eye irritation  2  1/52 (1.92%) 
Lacrimation increased  2  8/52 (15.38%) 
Vision blurred  2  4/52 (7.69%) 
Visual impairment  2  5/52 (9.62%) 
Vitreous detachment  2  1/52 (1.92%) 
Gastrointestinal disorders   
Abdominal pain  2  6/52 (11.54%) 
Abdominal pain upper  2  5/52 (9.62%) 
Aphthous stomatitis  2  1/52 (1.92%) 
Constipation  2  13/52 (25.00%) 
Diarrhoea  2  17/52 (32.69%) 
Dry mouth  2  2/52 (3.85%) 
Dyspepsia  2  10/52 (19.23%) 
Dysphagia  2  1/52 (1.92%) 
Eructation  2  1/52 (1.92%) 
Faeces discoloured  2  1/52 (1.92%) 
Gastric ulcer  2  1/52 (1.92%) 
Gastritis  2  1/52 (1.92%) 
Gastrooesophageal reflux disease  2  4/52 (7.69%) 
Haematochezia * 1  1/52 (1.92%) 
Haemorrhoids  2  2/52 (3.85%) 
Lip pain  2  2/52 (3.85%) 
Nausea  2  24/52 (46.15%) 
Oesophagitis  2  1/52 (1.92%) 
Oral pain  2  4/52 (7.69%) 
Proctalgia  2  1/52 (1.92%) 
Stomatitis  2  9/52 (17.31%) 
Swollen tongue  2  1/52 (1.92%) 
Vomiting  2  12/52 (23.08%) 
General disorders   
Asthenia  2  4/52 (7.69%) 
Catheter site pain  2  1/52 (1.92%) 
Chest discomfort  2  1/52 (1.92%) 
Chest pain  2  1/52 (1.92%) 
Chills  2  8/52 (15.38%) 
Face oedema  2  2/52 (3.85%) 
Fatigue  2  36/52 (69.23%) 
Gait disturbance  2  1/52 (1.92%) 
Influenza like illness  2  2/52 (3.85%) 
Mucosal inflammation  2  3/52 (5.77%) 
Oedema  2  2/52 (3.85%) 
Oedema peripheral  2  12/52 (23.08%) 
Pain  2  3/52 (5.77%) 
Pyrexia  2  12/52 (23.08%) 
Thrombosis in device  2  1/52 (1.92%) 
Hepatobiliary disorders   
Hepatic steatosis  2  2/52 (3.85%) 
Immune system disorders   
Drug hypersensitivity  2  1/52 (1.92%) 
Food allergy  2  1/52 (1.92%) 
Multiple allergies  2  1/52 (1.92%) 
Seasonal allergy  2  3/52 (5.77%) 
Infections and infestations   
Breast infection  2  1/52 (1.92%) 
Cellulitis  2  1/52 (1.92%) 
Ear infection  2  1/52 (1.92%) 
Fungal skin infection  2  1/52 (1.92%) 
Gastroenteritis  2  1/52 (1.92%) 
Influenza  2  2/52 (3.85%) 
Lobar pneumonia  2  2/52 (3.85%) 
Nasopharyngitis  2  2/52 (3.85%) 
Oral candidiasis  2  1/52 (1.92%) 
Pharyngitis  2  1/52 (1.92%) 
Pharyngotonsillitis * 1  1/52 (1.92%) 
Rhinitis  2  1/52 (1.92%) 
Sinusitis  2  4/52 (7.69%) 
Tooth infection  2  2/52 (3.85%) 
Upper respiratory tract infection  2  4/52 (7.69%) 
Urinary tract infection  2  7/52 (13.46%) 
Vulvovaginal mycotic infection  2  1/52 (1.92%) 
Injury, poisoning and procedural complications   
Ankle fracture  2  2/52 (3.85%) 
Corneal abrasion  2  1/52 (1.92%) 
Excoriation  2  1/52 (1.92%) 
Fall  2  1/52 (1.92%) 
Infusion related reaction  2  1/52 (1.92%) 
Ligament sprain  2  1/52 (1.92%) 
Meniscus injury  2  1/52 (1.92%) 
Muscle strain  2  1/52 (1.92%) 
Spinal compression fracture  2  1/52 (1.92%) 
Investigations   
Alanine aminotransferase increased * 1  2/52 (3.85%) 
Aspartate aminotransferase increased  2  1/52 (1.92%) 
Blood alkaline phosphatase increased  2  1/52 (1.92%) 
Blood cholesterol increased  2  1/52 (1.92%) 
Blood phosphorus decreased  2  1/52 (1.92%) 
Ejection fraction decreased  2  3/52 (5.77%) 
Electrocardiogram T wave abnormal  2  1/52 (1.92%) 
Electrocardiogram abnormal  2  1/52 (1.92%) 
Vitamin D decreased  2  1/52 (1.92%) 
Weight decreased  2  6/52 (11.54%) 
Weight increased  2  1/52 (1.92%) 
White blood cell count decreased  2  4/52 (7.69%) 
Metabolism and nutrition disorders   
Decreased appetite  2  13/52 (25.00%) 
Dehydration  2  4/52 (7.69%) 
Diabetes mellitus  2  1/52 (1.92%) 
Failure to thrive  2  1/52 (1.92%) 
Hypercalcaemia  2  1/52 (1.92%) 
Hyperglycaemia  2  3/52 (5.77%) 
Hyperphosphataemia  2  1/52 (1.92%) 
Hypertriglyceridaemia  2  1/52 (1.92%) 
Hyperuricaemia  2  1/52 (1.92%) 
Hypoalbuminaemia  2  1/52 (1.92%) 
Hypocalcaemia  2  1/52 (1.92%) 
Hypokalaemia  2  4/52 (7.69%) 
Hypomagnesaemia * 1  1/52 (1.92%) 
Hyponatraemia  2  2/52 (3.85%) 
Hypophosphataemia  2  3/52 (5.77%) 
Lactose intolerance  2  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  2  5/52 (9.62%) 
Back pain  2  8/52 (15.38%) 
Bone pain  2  7/52 (13.46%) 
Flank pain  2  1/52 (1.92%) 
Muscle spasms  2  7/52 (13.46%) 
Muscular weakness  2  3/52 (5.77%) 
Musculoskeletal chest pain  2  5/52 (9.62%) 
Musculoskeletal pain  2  4/52 (7.69%) 
Myalgia  2  4/52 (7.69%) 
Myopathy  2  1/52 (1.92%) 
Neck pain  2  1/52 (1.92%) 
Pain in extremity  2  4/52 (7.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cholangiocarcinoma  2  1/52 (1.92%) 
Melanocytic naevus  2  1/52 (1.92%) 
Neuroma  2  1/52 (1.92%) 
Nervous system disorders   
Ataxia  2  1/52 (1.92%) 
Balance disorder  2  3/52 (5.77%) 
Carpal tunnel syndrome  2  1/52 (1.92%) 
Dizziness  2  8/52 (15.38%) 
Dysgeusia  2  12/52 (23.08%) 
Headache  2  10/52 (19.23%) 
Hypoaesthesia  2  1/52 (1.92%) 
Memory impairment  2  1/52 (1.92%) 
Migraine  2  1/52 (1.92%) 
Neuralgia  2  1/52 (1.92%) 
Neuropathy peripheral  2  31/52 (59.62%) 
Paraesthesia  2  1/52 (1.92%) 
Peripheral motor neuropathy  2  3/52 (5.77%) 
Peripheral sensorimotor neuropathy  2  2/52 (3.85%) 
Peripheral sensory neuropathy  2  9/52 (17.31%) 
Peroneal nerve palsy  2  1/52 (1.92%) 
Syncope  2  1/52 (1.92%) 
Psychiatric disorders   
Anxiety  2  3/52 (5.77%) 
Confusional state  2  2/52 (3.85%) 
Depression  2  6/52 (11.54%) 
Insomnia  2  7/52 (13.46%) 
Renal and urinary disorders   
Bladder pain * 1  1/52 (1.92%) 
Chromaturia  2  1/52 (1.92%) 
Dysuria  2  1/52 (1.92%) 
Haematuria  2  1/52 (1.92%) 
Pollakiuria  2  2/52 (3.85%) 
Urinary retention  2  1/52 (1.92%) 
Reproductive system and breast disorders   
Bartholin's cyst  2  1/52 (1.92%) 
Breast pain  2  2/52 (3.85%) 
Vaginal haemorrhage  2  4/52 (7.69%) 
Vulvovaginal discomfort  2  1/52 (1.92%) 
Vulvovaginal dryness  2  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis  2  1/52 (1.92%) 
Chronic obstructive pulmonary disease  2  1/52 (1.92%) 
Cough  2  4/52 (7.69%) 
Dysphonia  2  2/52 (3.85%) 
Dyspnoea  2  7/52 (13.46%) 
Dyspnoea exertional  2  1/52 (1.92%) 
Epistaxis  2  4/52 (7.69%) 
Nasal congestion  2  3/52 (5.77%) 
Oropharyngeal discomfort  2  1/52 (1.92%) 
Painful respiration  2  1/52 (1.92%) 
Paranasal sinus hypersecretion  2  2/52 (3.85%) 
Pleural effusion  2  1/52 (1.92%) 
Productive cough  2  4/52 (7.69%) 
Pulmonary embolism  2  1/52 (1.92%) 
Pulmonary hypertension  2  1/52 (1.92%) 
Rhinorrhoea  2  1/52 (1.92%) 
Sinus congestion  2  1/52 (1.92%) 
Upper respiratory tract congestion  2  1/52 (1.92%) 
Upper-airway cough syndrome  2  1/52 (1.92%) 
Oropharyngeal pain * 1  7/52 (13.46%) 
Skin and subcutaneous tissue disorders   
Alopecia  2  46/52 (88.46%) 
Dermatitis allergic  2  1/52 (1.92%) 
Dermatitis contact  2  1/52 (1.92%) 
Dry skin  2  3/52 (5.77%) 
Heat rash  2  1/52 (1.92%) 
Night sweats  2  2/52 (3.85%) 
Onychoclasis  2  1/52 (1.92%) 
Pruritus  2  2/52 (3.85%) 
Rash  2  5/52 (9.62%) 
Rash maculo-papular  2  2/52 (3.85%) 
Rash pruritic * 1  1/52 (1.92%) 
Skin exfoliation  2  1/52 (1.92%) 
Skin fissures  2  1/52 (1.92%) 
Skin hyperpigmentation  2  2/52 (3.85%) 
Telangiectasia  2  1/52 (1.92%) 
Surgical and medical procedures   
Modified radical mastectomy  2  1/52 (1.92%) 
Vascular disorders   
Deep vein thrombosis  2  1/52 (1.92%) 
Flushing  2  1/52 (1.92%) 
Hot flush  2  4/52 (7.69%) 
Hypertension  2  1/52 (1.92%) 
Hypotension  2  1/52 (1.92%) 
Jugular vein thrombosis  2  1/52 (1.92%) 
Lymphoedema  2  3/52 (5.77%) 
Orthostatic hypotension  2  1/52 (1.92%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 16.0
2
Term from vocabulary, Select
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: Eisai Medical Services
Organization: Eisai Inc.
Phone: 1-888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01269346     History of Changes
Other Study ID Numbers: E7389-A001-208
First Submitted: December 31, 2010
First Posted: January 4, 2011
Results First Submitted: October 26, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017