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

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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was open to enrollment at four community oncology centers in the United States from July 2011 to June 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Informed consent was obtained from all subjects. Subjects must have had no prior treatment for invasive breast cancer.

Reporting Groups
  Description
Eribulin 1.1 mg/m2 Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
Eribulin 1.4 mg/m2 Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2

Participant Flow:   Overall Study
    Eribulin 1.1 mg/m2   Eribulin 1.4 mg/m2
STARTED   6   6 
COMPLETED   5 [1]   4 [2] 
NOT COMPLETED   1   2 
Adverse Event                1                2 
[1] one subject ended study treatment due to adverse events
[2] two subjects ended study treatment due to adverse events



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Eribulin 1.1 mg/m2 Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
Eribulin 1.4 mg/m2 Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
Total Total of all reporting groups

Baseline Measures
   Eribulin 1.1 mg/m2   Eribulin 1.4 mg/m2   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   6   6   12 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.2  (7.47)   53.0  (9.14)   53.1  (7.96) 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   6   6   12 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 32.4  (6.79)   32.4  (4.59)   32.4  (5.52) 


  Outcome Measures
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1.  Primary:   Pathologic Response   [ Time Frame: Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start ]

2.  Secondary:   Clinical Response   [ Time Frame: Assessed prior to definitive surgery, approximately 18 weeks from study treatment start. ]

3.  Other Pre-specified:   Maximum Tolerated Dose (MTD) of Eribulin in Combination With Carboplatin and Trastuzuamb   [ Time Frame: Approximately 22 days from study treatment start, per subject ]

4.  Other Pre-specified:   Dose Limiting Toxicity (DLT)   [ Time Frame: Approximately 22 days from study treatment start, per subject ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: mwalker@vectoroncology.com



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