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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 : May 7, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort A: Triple-negative Breast Cancer Patients 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.
Cohort B: ER/PR Positive/HER2-negative Breast Cancer 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.
Cohort C: HER2-positive Breast Cancer Patients 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.

Participant Flow for 2 periods

Period 1:   Enrolled
    Cohort A: Triple-negative Breast Cancer Patients   Cohort B: ER/PR Positive/HER2-negative Breast Cancer   Cohort C: HER2-positive Breast Cancer Patients
STARTED   54   42   31 
COMPLETED   53   42   31 
NOT COMPLETED   1   0   0 
Withdrawal by Subject                1                0                0 

Period 2:   Treated
    Cohort A: Triple-negative Breast Cancer Patients   Cohort B: ER/PR Positive/HER2-negative Breast Cancer   Cohort C: HER2-positive Breast Cancer Patients
STARTED   53   42   31 
COMPLETED   46   34   26 
NOT COMPLETED   7   8   5 
Disease Progression                2                2                1 
Adverse Event                4                3                2 
Withdrawal by Subject                1                2                2 
Protocol Violation                0                1                0 



  Baseline Characteristics

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.
All patients who receive at least one dose of treatment.

Reporting Groups
  Description
Cohort A: Triple-negative Breast Cancer Patients 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.
Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients 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.
Cohort C: HER2-positive Breast Cancer Patients 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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 53   42   31   126 
Age 
[Units: Years]
Median (Full Range)
 49 
 (28 to 74) 
 55 
 (27 to 71) 
 52 
 (38 to 78) 
 52 
 (27 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
       
United States   53   42   31   126 


  Outcome Measures

1.  Primary:   Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy   [ Time Frame: Up to 2 years ]

2.  Secondary:   Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment Feasibility   [ Time Frame: up to 18 weeks ]

3.  Secondary:   The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety   [ Time Frame: Weekly during each 21 day cycle and for 30 days after completion of protocol-specific treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 less than or equal to 60 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: Senior Director, Regulatory Science
Organization: Sarah Cannon Development Innovations
phone: 844-710-6157
e-mail: CANN.InnovationsMedical@sarahcannon.com


Publications:

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: May 7, 2018