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Trial record 87 of 157 for:    eribulin

Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT01498588
Recruitment Status : Terminated (Slow accrual)
First Posted : December 23, 2011
Results First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Keerthi Gogineni, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Neoplasms
Breast Cancer
Breast Tumors
Cancer of the Breast
Neoplasms, Breast
Tumors, Breast
Interventions Drug: Eribulin
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Pegfilgrastim
Enrollment 7
Recruitment Details This study was open to accrual from October 2011 to June 2015. Enrolled participants were from Winship Cancer Institute of Emory University and Emory University Hospital Midtown.
Pre-assignment Details  
Arm/Group Title Eribulin+Doxorubicin+Cyclophosphamide
Hide Arm/Group Description

Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide

Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:

Day 1: Eribulin 1.4mg/m² IV

Day 8: Eribulin 1.4mg/m² IV

Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:

Day 1: Doxorubicin 60mg/m² IV

Day 1: Cyclophosphamide 600mg/m² IV

Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Eribulin+Doxorubicin+Cyclophosphamide
Hide Arm/Group Description

Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide

Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:

Day 1: Eribulin 1.4mg/m² IV

Day 8: Eribulin 1.4mg/m² IV

Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:

Day 1: Doxorubicin 60mg/m² IV

Day 1: Cyclophosphamide 600mg/m² IV

Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
7
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
  85.7%
Unknown or Not Reported
1
  14.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native
1
  14.3%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  42.9%
White
2
  28.6%
More than one race
0
   0.0%
Unknown or Not Reported
1
  14.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Pathologic Complete Response Rate at the Time of Surgery
Hide Description Patients will receive treatment for 20 weeks with primary outcome measured at the time of surgery. Surgery is typically 4-6 weeks after completion of chemotherapy, so patients will be on study for 24 weeks on average. Response was measured by pathologist’s standard of care assessment of extent of residual disease. If the patient had no evidence of invasive or in situ residual disease present in the breast and lymph node (i.e. ypT0N0), then this was defined as a pathologic complete response (pCR). Reported is the number of participants showing pCR.
Time Frame Average of 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Pathology information at the time of definitive resection was available for six of seven patients. One patient was ultimately lost to follow-up.
Arm/Group Title Eribulin+Doxorubicin+Cyclophosphamide
Hide Arm/Group Description:

Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide

Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:

Day 1: Eribulin 1.4mg/m² IV

Day 8: Eribulin 1.4mg/m² IV

Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:

Day 1: Doxorubicin 60mg/m² IV

Day 1: Cyclophosphamide 600mg/m² IV

Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Pathologic Complete Response (pCR) 1
No pCR 5
Unknown 1
2.Secondary Outcome
Title Toxicity of Chemotherapy Regimen (Number of Participants With Any Adverse Events)
Hide Description Toxicity of chemotherapy at each physician visit using Common Toxicity Criteria for Adverse Effects (CTCAE) criteria.
Time Frame Through 20 weeks of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eribulin+Doxorubicin+Cyclophosphamide
Hide Arm/Group Description:

Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide

Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:

Day 1: Eribulin 1.4mg/m² IV

Day 8: Eribulin 1.4mg/m² IV

Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:

Day 1: Doxorubicin 60mg/m² IV

Day 1: Cyclophosphamide 600mg/m² IV

Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin+Doxorubicin+Cyclophosphamide
Hide Arm/Group Description

Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide

Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:

Day 1: Eribulin 1.4mg/m² IV

Day 8: Eribulin 1.4mg/m² IV

Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:

Day 1: Doxorubicin 60mg/m² IV

Day 1: Cyclophosphamide 600mg/m² IV

Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy

All-Cause Mortality
Eribulin+Doxorubicin+Cyclophosphamide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin+Doxorubicin+Cyclophosphamide
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eribulin+Doxorubicin+Cyclophosphamide
Affected / at Risk (%)
Total   2/7 (28.57%) 
Blood and lymphatic system disorders   
Hemorrhage *  1/7 (14.29%) 
Gastrointestinal disorders   
Anorexia *  1/7 (14.29%) 
General disorders   
Fatigue *  1/7 (14.29%) 
Insomnia *  1/7 (14.29%) 
Metabolism and nutrition disorders   
Hypoalbuminemia *  1/7 (14.29%) 
Elevated ALT *  1/7 (14.29%) 
Elevated AST *  1/7 (14.29%) 
Hypercalcemia *  1/7 (14.29%) 
Hyperglycemia *  1/7 (14.29%) 
Hyponatremia *  1/7 (14.29%) 
Nervous system disorders   
Neuropathy *  2/7 (28.57%) 
Respiratory, thoracic and mediastinal disorders   
Cough *  1/7 (14.29%) 
Skin and subcutaneous tissue disorders   
Rash *  1/7 (14.29%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Keerthi Gogineni, MD, MSHP
Organization: Emory University
Phone: 404-778-1801
Responsible Party: Keerthi Gogineni, Emory University
ClinicalTrials.gov Identifier: NCT01498588     History of Changes
Other Study ID Numbers: IRB00050068
WCI1937-10 ( Other Identifier: Other )
First Submitted: October 13, 2011
First Posted: December 23, 2011
Results First Submitted: June 21, 2016
Results First Posted: October 3, 2016
Last Update Posted: October 3, 2016