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Trial record 49 of 157 for:    eribulin

Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT01388647
Recruitment Status : Terminated (Closed early due to increased hematologic toxicity and possible reduced efficacy)
First Posted : July 7, 2011
Results First Posted : August 28, 2015
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Vector Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HER-2 Positive Breast Cancer
Interventions Drug: eribulin
Drug: carboplatin
Drug: trastuzumab
Enrollment 12
Recruitment Details This study was open to enrollment at four community oncology centers in the United States from July 2011 to June 2014.
Pre-assignment Details Informed consent was obtained from all subjects. Subjects must have had no prior treatment for invasive breast cancer.
Arm/Group Title Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2
Hide Arm/Group Description Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2 Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
Period Title: Overall Study
Started 6 6
Completed 5 [1] 4 [2]
Not Completed 1 2
Reason Not Completed
Adverse Event             1             2
[1]
one subject ended study treatment due to adverse events
[2]
two subjects ended study treatment due to adverse events
Arm/Group Title Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2 Total
Hide Arm/Group Description Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2 Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2 Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
53.2  (7.47) 53.0  (9.14) 53.1  (7.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
6
 100.0%
6
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants 6 participants 12 participants
32.4  (6.79) 32.4  (4.59) 32.4  (5.52)
1.Primary Outcome
Title Pathologic Response
Hide Description Definitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response (no invasive cancer in breast or lymph nodes; residual DCIS or LCIS is acceptable), partial pathologic response (residual invasive cancer in breast and/or lymph nodes), or no response (pathologic staging is equal to or worse than pretreatment clinical staging).
Time Frame Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2
Hide Arm/Group Description:
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Complete Response
16.7
(0.4 to 64.1)
16.7
(0.4 to 64.1)
Partial Response
83.3
(35.9 to 99.6)
83.3
(35.9 to 99.6)
2.Secondary Outcome
Title Clinical Response
Hide Description Clinical assessment of response will be performed 3 weeks after completion of study treatment. The treating physician will assess clinical response using physical examination and radiologic evaluation. Clinical response options are complete response (no invasive tumor in breast and lymph nodes), partial response (> 50% reduction in longest diameter of pretreatment tumor), no response (< 50% response to 10% growth of tumor as determined by longest diameter of pretreatment tumor size), and progression.
Time Frame Assessed prior to definitive surgery, approximately 18 weeks from study treatment start.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2
Hide Arm/Group Description:
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Complete Response
16.7
(0.4 to 64.1)
50.0
(11.8 to 88.2)
Partial Response
83.3
(35.9 to 99.6)
33.3
(4.3 to 77.7)
Missing
0
(0 to 0)
16.7
(0.4 to 64.1)
3.Other Pre-specified Outcome
Title Maximum Tolerated Dose (MTD) of Eribulin in Combination With Carboplatin and Trastuzuamb
Hide Description The MTD is defined as the dose at which <= 1 of 6 subjects experience DLT (Dose Limiting Toxicity) and above which >= 2 of 6 subjects experience DLT.
Time Frame Approximately 22 days from study treatment start, per subject
Hide Outcome Measure Data
Hide Analysis Population Description
The MTD of ECH as neoadjuvant therapy for HER2+ breast cancer was determined per protocol definitions; however, due to the combination of increased hematologic toxicity and possible reduced efficacy, Phase II of this trial was not initiated.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
All subjects were assigned to receive either a starting dose of eribulin 1.1 mg/m^2 or eribulin 1.4 mg/m^2.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: mg/m^2
1.1
4.Other Pre-specified Outcome
Title Dose Limiting Toxicity (DLT)
Hide Description DLT is defined as grade 4 thrombocytopenia; grade 4 anemia; grade 4 neutropenia lasting > 5 days; or any grade 3 or 4 non-hematologic toxicity occurring during Cycle 1 which is attributable to eribulin, carboplatin, trastuzumab or the combination, or the inability to deliver all three agents at the assigned dose and scheduled time during Cycle 1.The following events are excluded from the DLT definition: grade 3 nausea and/or vomiting responsive to antiemetics; grade 3 fever or infection; grade 3 diarrhea responsive to antidiarrheal therapy.
Time Frame Approximately 22 days from study treatment start, per subject
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2
Hide Arm/Group Description:
Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Grade 4 thrombocytopenia 1 1
Inability to deliver all 3 agents at assigned dose 0 2
Time Frame Adverse events were collected beginning at the start of study treatment until 21 days after the subject's last study treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2
Hide Arm/Group Description Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2 Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
All-Cause Mortality
Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2
Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   3/6 (50.00%) 
Blood and lymphatic system disorders     
Anemia * 1  1/6 (16.67%)  1/6 (16.67%) 
Febrile Neutropenia * 1  0/6 (0.00%)  1/6 (16.67%) 
Infections and infestations     
Pneumonia * 1  0/6 (0.00%)  1/6 (16.67%) 
Investigations     
Neutrophil Count Decreased * 1  1/6 (16.67%)  1/6 (16.67%) 
Metabolism and nutrition disorders     
Hyperglycaemia * 1  0/6 (0.00%)  1/6 (16.67%) 
Renal and urinary disorders     
Renal Failure Acute * 1  0/6 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism * 1  1/6 (16.67%)  0/6 (0.00%) 
Surgical and medical procedures     
Cholecystectomy * 1  1/6 (16.67%)  0/6 (0.00%) 
Vascular disorders     
Aortitis * 1  1/6 (16.67%)  0/6 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eribulin 1.1 mg/m2 Eribulin 1.4 mg/m2
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  5/6 (83.33%)  3/6 (50.00%) 
Iron Deficiency Anemia  1  1/6 (16.67%)  1/6 (16.67%) 
Congenital, familial and genetic disorders     
Hypophosphatasia  1  0/6 (0.00%)  1/6 (16.67%) 
Ear and labyrinth disorders     
Hearing Impaired  1  0/6 (0.00%)  1/6 (16.67%) 
Eye disorders     
Vision Blurred  1  1/6 (16.67%)  1/6 (16.67%) 
Gastrointestinal disorders     
Abdominal Distension  1  1/6 (16.67%)  0/6 (0.00%) 
Abdominal Pain  1  1/6 (16.67%)  3/6 (50.00%) 
Constipation  1  2/6 (33.33%)  3/6 (50.00%) 
Diarrhea  1  1/6 (16.67%)  4/6 (66.67%) 
Dyspepsia  1  1/6 (16.67%)  1/6 (16.67%) 
Gastroesophageal Reflux Disease  1  1/6 (16.67%)  2/6 (33.33%) 
Nausea  1  4/6 (66.67%)  6/6 (100.00%) 
Vomiting  1  2/6 (33.33%)  4/6 (66.67%) 
General disorders     
Adverse Drug Reaction  1  0/6 (0.00%)  1/6 (16.67%) 
Asthenia  1  1/6 (16.67%)  0/6 (0.00%) 
Chest Pain  1  0/6 (0.00%)  1/6 (16.67%) 
Chills  1  0/6 (0.00%)  2/6 (33.33%) 
Fatigue  1  5/6 (83.33%)  4/6 (66.67%) 
Gait Disturbance  1  0/6 (0.00%)  2/6 (33.33%) 
Mucosal Inflammation  1  0/6 (0.00%)  1/6 (16.67%) 
Edema Peripheral  1  1/6 (16.67%)  2/6 (33.33%) 
Pain  1  1/6 (16.67%)  1/6 (16.67%) 
Pyrexia  1  1/6 (16.67%)  3/6 (50.00%) 
Immune system disorders     
Hypersensitivity  1  2/6 (33.33%)  0/6 (0.00%) 
Seasonal Allergy  1  0/6 (0.00%)  1/6 (16.67%) 
Infections and infestations     
Skin Infection  1  0/6 (0.00%)  1/6 (16.67%) 
Upper Respiratory Tract Infection  1  1/6 (16.67%)  1/6 (16.67%) 
Urinary Tract Infection  1  1/6 (16.67%)  2/6 (33.33%) 
Vulvovaginal Mycotic Infection  1  1/6 (16.67%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/6 (0.00%)  1/6 (16.67%) 
Investigations     
Alanine Aminotransferase Increased  1  1/6 (16.67%)  1/6 (16.67%) 
Aspartate Aminotransferase Increased  1  1/6 (16.67%)  1/6 (16.67%) 
Blood Alkaline Phosphatase Increased  1  1/6 (16.67%)  0/6 (0.00%) 
Blood Bilirubin Increased  1  0/6 (0.00%)  1/6 (16.67%) 
Blood Creatinine Increased  1  0/6 (0.00%)  1/6 (16.67%) 
Neutrophil Count Decreased  1  4/6 (66.67%)  5/6 (83.33%) 
Occult Blood Positive  1  0/6 (0.00%)  1/6 (16.67%) 
Platelet Count Decreased  1  5/6 (83.33%)  3/6 (50.00%) 
Romberg Test Positive  1  0/6 (0.00%)  1/6 (16.67%) 
Weight Decreased  1  0/6 (0.00%)  1/6 (16.67%) 
White Blood Cell Count Decreased  1  2/6 (33.33%)  2/6 (33.33%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  0/6 (0.00%)  1/6 (16.67%) 
Dehydration  1  1/6 (16.67%)  0/6 (0.00%) 
Hypocalcaemia  1  0/6 (0.00%)  1/6 (16.67%) 
Hypokalemia  1  1/6 (16.67%)  3/6 (50.00%) 
Hypomagnesaemia  1  1/6 (16.67%)  4/6 (66.67%) 
Hypouricemia  1  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/6 (16.67%)  1/6 (16.67%) 
Back Pain  1  0/6 (0.00%)  2/6 (33.33%) 
Bone Pain  1  1/6 (16.67%)  0/6 (0.00%) 
Joint Range of Motion Decreased  1  0/6 (0.00%)  1/6 (16.67%) 
Muscle Spasms  1  0/6 (0.00%)  1/6 (16.67%) 
Muscular Weakness  1  0/6 (0.00%)  1/6 (16.67%) 
Myalgia  1  2/6 (33.33%)  1/6 (16.67%) 
Nervous system disorders     
Ataxia  1  0/6 (0.00%)  1/6 (16.67%) 
Dizziness  1  3/6 (50.00%)  3/6 (50.00%) 
Dysgeusia  1  0/6 (0.00%)  2/6 (33.33%) 
Headache  1  3/6 (50.00%)  3/6 (50.00%) 
Hypoesthesia  1  0/6 (0.00%)  1/6 (16.67%) 
Hyporeflexia  1  0/6 (0.00%)  1/6 (16.67%) 
Neuropathy Peripheral  1  0/6 (0.00%)  1/6 (16.67%) 
Peripheral Sensory Neuropathy  1  2/6 (33.33%)  3/6 (50.00%) 
Syncope  1  2/6 (33.33%)  0/6 (0.00%) 
Psychiatric disorders     
Agitation  1  0/6 (0.00%)  1/6 (16.67%) 
Anxiety  1  0/6 (0.00%)  1/6 (16.67%) 
Insomnia  1  0/6 (0.00%)  1/6 (16.67%) 
Renal and urinary disorders     
Dysuria  1  1/6 (16.67%)  1/6 (16.67%) 
Hematuria  1  1/6 (16.67%)  0/6 (0.00%) 
Renal Failure Acute  1  0/6 (0.00%)  1/6 (16.67%) 
Reproductive system and breast disorders     
Breast Discharge  1  1/6 (16.67%)  0/6 (0.00%) 
Breast Pain  1  1/6 (16.67%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/6 (0.00%)  2/6 (33.33%) 
Dyspnea  1  1/6 (16.67%)  2/6 (33.33%) 
Dyspnea Exertional  1  1/6 (16.67%)  1/6 (16.67%) 
Epistaxis  1  0/6 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  3/6 (50.00%)  4/6 (66.67%) 
Dry Skin  1  0/6 (0.00%)  1/6 (16.67%) 
Petechiae  1  1/6 (16.67%)  0/6 (0.00%) 
Pruritus  1  0/6 (0.00%)  1/6 (16.67%) 
Rash  1  0/6 (0.00%)  1/6 (16.67%) 
Rash Maculo-papular  1  0/6 (0.00%)  1/6 (16.67%) 
Surgical and medical procedures     
Antibiotic Prophylasis  1  0/6 (0.00%)  1/6 (16.67%) 
Vascular disorders     
Deep Vein Thrombosis  1  1/6 (16.67%)  0/6 (0.00%) 
Embolism  1  0/6 (0.00%)  1/6 (16.67%) 
Hematoma  1  0/6 (0.00%)  1/6 (16.67%) 
Hypotension  1  1/6 (16.67%)  0/6 (0.00%) 
Lymphedema  1  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Although MTD of eribulin with carboplatin & trastuzuamb as neoadjuvant therapy was determined by protocol definitions, study closed early due to increased hematologic toxicity & possible reduced efficacy. Phase II of this trial was not initiated.
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.
Results Point of Contact
Name/Title: Vice President of Scientific Affairs
Organization: Vector Oncology
Phone: 901-435-5550 ext 1759
Responsible Party: Vector Oncology
ClinicalTrials.gov Identifier: NCT01388647     History of Changes
Other Study ID Numbers: ALSSNBC1006
First Submitted: July 5, 2011
First Posted: July 7, 2011
Results First Submitted: May 28, 2015
Results First Posted: August 28, 2015
Last Update Posted: August 28, 2015