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Trial record 48 of 157 for:    eribulin

Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

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ClinicalTrials.gov Identifier: NCT01401959
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : May 7, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Eribulin
Drug: Trastuzumab
Enrollment 127
Recruitment Details Between September 2011 to April 2015, 127 female patients who did not achieve a pathologic complete response (pCR i.e. have residual invasive disease in breast or lymph node tissue) after treatment with a standard neoadjuvant chemotherapy regimen and surgery were enrolled. Of those 127 patients enrolled, 126 patients received treatment.
Pre-assignment Details  
Arm/Group Title Cohort A: Triple-negative Breast Cancer Patients Cohort B: ER/PR Positive/HER2-negative Breast Cancer Cohort C: HER2-positive Breast Cancer Patients
Hide Arm/Group Description Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
Period Title: Enrolled
Started 54 42 31
Completed 53 42 31
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Period Title: Treated
Started 53 42 31
Completed 46 34 26
Not Completed 7 8 5
Reason Not Completed
Disease Progression             2             2             1
Adverse Event             4             3             2
Withdrawal by Subject             1             2             2
Protocol Violation             0             1             0
Arm/Group Title Cohort A: Triple-negative Breast Cancer Patients Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients Cohort C: HER2-positive Breast Cancer Patients Total
Hide Arm/Group Description Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days. Total of all reporting groups
Overall Number of Baseline Participants 53 42 31 126
Hide Baseline Analysis Population Description
All patients who receive at least one dose of treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 53 participants 42 participants 31 participants 126 participants
49
(28 to 74)
55
(27 to 71)
52
(38 to 78)
52
(27 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 42 participants 31 participants 126 participants
Female
53
 100.0%
42
 100.0%
31
 100.0%
126
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 42 participants 31 participants 126 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  22.6%
4
   9.5%
2
   6.5%
18
  14.3%
White
39
  73.6%
37
  88.1%
28
  90.3%
104
  82.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   3.8%
1
   2.4%
1
   3.2%
4
   3.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 53 participants 42 participants 31 participants 126 participants
53
 100.0%
42
 100.0%
31
 100.0%
126
 100.0%
1.Primary Outcome
Title Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy
Hide Description The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who receive at least one dose of treatment
Arm/Group Title Cohort A: Triple-negative Breast Cancer Patients Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients Cohort C: HER2-positive Breast Cancer Patients
Hide Arm/Group Description:
Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
Overall Number of Participants Analyzed 53 42 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
56
(42 to 69)
83
(67 to 91)
73
(53 to 86)
2.Secondary Outcome
Title Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment Feasibility
Hide Description Examines the feasibility of administering 6 cycles (21 days per cycle) of eribulin without toxicity or disease worsening following standard neoadjuvant chemotherapy and surgery.
Time Frame up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of treatment
Arm/Group Title Cohort A: Triple-negative Breast Cancer Patients Cohort B: ER/PR Positive/HER2-negative Breast Cancer Cohort C: HER2-positive Breast Cancer Patients
Hide Arm/Group Description:
Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
Overall Number of Participants Analyzed 53 42 31
Measure Type: Count of Participants
Unit of Measure: Participants
46
  86.8%
34
  81.0%
26
  83.9%
3.Secondary Outcome
Title The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety
Hide Description A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.
Time Frame Weekly during each 21 day cycle and for 30 days after completion of protocol-specific treatment. After that patients were followed every 3 months for up to 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who receive at least one dose of treatment.
Arm/Group Title Cohort A: Triple-negative Breast Cancer Patients Cohort B: ER/PR Positive/HER2-negative Breast Cancer Cohort C: HER2-positive Breast Cancer Patients
Hide Arm/Group Description:
Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.
Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
Overall Number of Participants Analyzed 53 42 31
Measure Type: Count of Participants
Unit of Measure: Participants
50
  94.3%
41
  97.6%
31
 100.0%
Time Frame Day 1 and Day 8 of every treatment cycle and 30 days after discontinuation or completion of treatment for up to 22.2 weeks
Adverse Event Reporting Description All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
 
Arm/Group Title Cohort A: Triple-negative Breast Cancer Cohort B: ER/PR Positive/HER2-negative Breast Cancer Cohort C: HER2 Positive Breast Cancer
Hide Arm/Group Description Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.
All-Cause Mortality
Cohort A: Triple-negative Breast Cancer Cohort B: ER/PR Positive/HER2-negative Breast Cancer Cohort C: HER2 Positive Breast Cancer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/53 (11.32%)   4/42 (9.52%)   1/31 (3.23%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A: Triple-negative Breast Cancer Cohort B: ER/PR Positive/HER2-negative Breast Cancer Cohort C: HER2 Positive Breast Cancer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/53 (15.09%)   1/42 (2.38%)   3/31 (9.68%) 
Blood and lymphatic system disorders       
Febrile neutropenia * 1  1/53 (1.89%)  0/42 (0.00%)  0/31 (0.00%) 
Cardiac disorders       
Cardiac failure congestive * 1  1/53 (1.89%)  0/42 (0.00%)  0/31 (0.00%) 
Ventricular arrhythmia * 1  1/53 (1.89%)  0/42 (0.00%)  0/31 (0.00%) 
Infections and infestations       
Cellulitis * 1  0/53 (0.00%)  0/42 (0.00%)  1/31 (3.23%) 
Mastitis * 1  1/53 (1.89%)  0/42 (0.00%)  0/31 (0.00%) 
Pneumonia * 1  1/53 (1.89%)  0/42 (0.00%)  0/31 (0.00%) 
Sinusitis * 1  0/53 (0.00%)  0/42 (0.00%)  1/31 (3.23%) 
Tracheobronchitis * 1  0/53 (0.00%)  1/42 (2.38%)  0/31 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control * 1  0/53 (0.00%)  0/42 (0.00%)  1/31 (3.23%) 
Hyperglycaemia * 1  1/53 (1.89%)  0/42 (0.00%)  0/31 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastasis * 1  1/53 (1.89%)  0/42 (0.00%)  0/31 (0.00%) 
Nervous system disorders       
Seizure * 1  1/53 (1.89%)  0/42 (0.00%)  0/31 (0.00%) 
1
Term from vocabulary, CTCAE (unspecified)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A: Triple-negative Breast Cancer Cohort B: ER/PR Positive/HER2-negative Breast Cancer Cohort C: HER2 Positive Breast Cancer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   52/52 (100.00%)   42/42 (100.00%)   31/31 (100.00%) 
Blood and lymphatic system disorders       
Anemia * 1  20/52 (38.46%)  13/42 (30.95%)  16/31 (51.61%) 
Ear and labyrinth disorders       
Tinnitus * 1  2/52 (3.85%)  0/42 (0.00%)  2/31 (6.45%) 
Eye disorders       
Blurred Vision * 1  2/52 (3.85%)  2/42 (4.76%)  2/31 (6.45%) 
Watering Eyes * 1  5/52 (9.62%)  5/42 (11.90%)  1/31 (3.23%) 
Gastrointestinal disorders       
Nausea * 1  18/52 (34.62%)  16/42 (38.10%)  14/31 (45.16%) 
Constipation * 1  14/52 (26.92%)  13/42 (30.95%)  9/31 (29.03%) 
Diarrhea * 1  8/52 (15.38%)  10/42 (23.81%)  6/31 (19.35%) 
Vomiting * 1  6/52 (11.54%)  2/42 (4.76%)  5/31 (16.13%) 
Abdominal Pain * 1  5/52 (9.62%)  2/42 (4.76%)  5/31 (16.13%) 
Mucositis * 1  4/52 (7.69%)  6/42 (14.29%)  4/31 (12.90%) 
Dyspepsia * 1  8/52 (15.38%)  7/42 (16.67%)  3/31 (9.68%) 
Gastroesophageal Reflux Disease * 1  3/52 (5.77%)  4/42 (9.52%)  3/31 (9.68%) 
Cheilitis * 1  0/52 (0.00%)  0/42 (0.00%)  2/31 (6.45%) 
Dry Mouth * 1  3/52 (5.77%)  2/42 (4.76%)  0/31 (0.00%) 
General disorders       
Fatigue * 1  33/52 (63.46%)  26/42 (61.90%)  23/31 (74.19%) 
Edema * 1  4/52 (7.69%)  7/42 (16.67%)  6/31 (19.35%) 
Fever * 1  1/52 (1.92%)  5/42 (11.90%)  3/31 (9.68%) 
Pain * 1  7/52 (13.46%)  4/42 (9.52%)  2/31 (6.45%) 
Non-Cardiac Chest Pain * 1  1/52 (1.92%)  1/42 (2.38%)  2/31 (6.45%) 
Chills * 1  2/52 (3.85%)  5/42 (11.90%)  1/31 (3.23%) 
Infections and infestations       
Upper Respiratory Infection * 1  7/52 (13.46%)  4/42 (9.52%)  2/31 (6.45%) 
Urinary Tract Infection * 1  1/52 (1.92%)  0/42 (0.00%)  2/31 (6.45%) 
Nail Infection * 1  0/52 (0.00%)  3/42 (7.14%)  1/31 (3.23%) 
Infections And Infestations - Other, Herpes Zoster * 1  3/52 (5.77%)  1/42 (2.38%)  1/31 (3.23%) 
Investigations       
Neutrophil Count Decreased * 1  26/52 (50.00%)  21/42 (50.00%)  17/31 (54.84%) 
Leukopenia * 1  15/52 (28.85%)  23/42 (54.76%)  12/31 (38.71%) 
Lymphocyte Count Decreased * 1  0/52 (0.00%)  1/42 (2.38%)  5/31 (16.13%) 
Alanine Aminotransferase Increased * 1  3/52 (5.77%)  6/42 (14.29%)  3/31 (9.68%) 
Platelet Count Decreased * 1  3/52 (5.77%)  4/42 (9.52%)  2/31 (6.45%) 
Aspartate Aminotransferase Increased * 1  3/52 (5.77%)  5/42 (11.90%)  0/31 (0.00%) 
Metabolism and nutrition disorders       
Anorexia * 1  3/52 (5.77%)  5/42 (11.90%)  3/31 (9.68%) 
Hypomagnesemia * 1  3/52 (5.77%)  3/42 (7.14%)  3/31 (9.68%) 
Hyperglycemia * 1  5/52 (9.62%)  4/42 (9.52%)  2/31 (6.45%) 
Dehydration * 1  2/52 (3.85%)  1/42 (2.38%)  2/31 (6.45%) 
Hyponatremia * 1  0/52 (0.00%)  3/42 (7.14%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  20/52 (38.46%)  8/42 (19.05%)  12/31 (38.71%) 
Myalgia * 1  13/52 (25.00%)  9/42 (21.43%)  9/31 (29.03%) 
Bone Pain * 1  7/52 (13.46%)  7/42 (16.67%)  4/31 (12.90%) 
Pain In Extremity * 1  7/52 (13.46%)  4/42 (9.52%)  3/31 (9.68%) 
Generalized Muscle Weakness * 1  0/52 (0.00%)  0/42 (0.00%)  3/31 (9.68%) 
Back Pain * 1  4/52 (7.69%)  3/42 (7.14%)  2/31 (6.45%) 
Nervous system disorders       
Peripheral Sensory Neuropathy * 1  24/52 (46.15%)  25/42 (59.52%)  16/31 (51.61%) 
Headache * 1  11/52 (21.15%)  12/42 (28.57%)  5/31 (16.13%) 
Dizziness * 1  9/52 (17.31%)  6/42 (14.29%)  3/31 (9.68%) 
Dysgeusia * 1  7/52 (13.46%)  2/42 (4.76%)  1/31 (3.23%) 
Paresthesia * 1  4/52 (7.69%)  1/42 (2.38%)  1/31 (3.23%) 
Psychiatric disorders       
Insomnia * 1  11/52 (21.15%)  8/42 (19.05%)  5/31 (16.13%) 
Anxiety * 1  5/52 (9.62%)  7/42 (16.67%)  5/31 (16.13%) 
Depression * 1  4/52 (7.69%)  5/42 (11.90%)  4/31 (12.90%) 
Cognitive Disturbance * 1  0/52 (0.00%)  0/42 (0.00%)  2/31 (6.45%) 
Reproductive system and breast disorders       
Breast Pain * 1  4/52 (7.69%)  4/42 (9.52%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea * 1  5/52 (9.62%)  6/42 (14.29%)  5/31 (16.13%) 
Cough * 1  8/52 (15.38%)  6/42 (14.29%)  3/31 (9.68%) 
Nasal Congestion * 1  1/52 (1.92%)  3/42 (7.14%)  3/31 (9.68%) 
Allergic Rhinitis * 1  0/52 (0.00%)  1/42 (2.38%)  3/31 (9.68%) 
Sore Throat * 1  4/52 (7.69%)  4/42 (9.52%)  2/31 (6.45%) 
Respiratory, Thoracic And Mediastinal Disorders - Other, Runny Nose * 1  3/52 (5.77%)  4/42 (9.52%)  1/31 (3.23%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  11/52 (21.15%)  11/42 (26.19%)  5/31 (16.13%) 
Rash * 1  6/52 (11.54%)  5/42 (11.90%)  5/31 (16.13%) 
Skin And Subcutaneous Tissue Disorders - Other, Erythema * 1  2/52 (3.85%)  2/42 (4.76%)  2/31 (6.45%) 
Vascular disorders       
Lymphedema * 1  5/52 (9.62%)  1/42 (2.38%)  4/31 (12.90%) 
Hot Flashes * 1  5/52 (9.62%)  4/42 (9.52%)  3/31 (9.68%) 
Hypertension * 1  3/52 (5.77%)  6/42 (14.29%)  1/31 (3.23%) 
1
Term from vocabulary, CTCAE (unspecified)
*
Indicates events were collected by non-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.
Results Point of Contact
Name/Title: Senior Director, Regulatory Science
Organization: Sarah Cannon Development Innovations
Phone: 844-710-6157
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01401959     History of Changes
Other Study ID Numbers: SCRI BRE 186
First Submitted: July 20, 2011
First Posted: July 26, 2011
Results First Submitted: April 4, 2018
Results First Posted: May 7, 2018
Last Update Posted: June 15, 2018