Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01527487
First received: January 31, 2012
Last updated: July 15, 2016
Last verified: July 2016
Results First Received: March 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HER2 Negative Breast Cancer
Interventions: Drug: Eribulin
Drug: Cyclophosphamide
Drug: Docetaxel

  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 neoadjuvant trial evaluated the combination of eribulin/cyclophosphamide (ErC) versus docetaxel/cyclophosphamide (TC) in women with clinical stage II-III breast cancers. Between JUN 2012 and APR 2014, 76 patients were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a 10-patient lead-in to confirm safety and feasibility of ErC, subsequent patients (66) were randomized 2 to 1 for treatment with: (1) ErC (44 patients) or (2) TC (22 patients). Both regimens were administered every 21 days for 6 cycles followed by surgery.

Reporting Groups
  Description
Eribulin+Cyclophosphamide: ErC

Eribulin (Er): 1.4 mg/m^2 by IV infusion (Days 1 and 8); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)

Administered every 21 days for 6 cycles followed by surgery.

Docetaxel+Cyclophosphamide: TC

Docetaxel (T): 75 mg/m^2 by IV infusion (Day 1); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)tandard.

Administered every 21 days for 6 cycles followed by surgery.


Participant Flow:   Overall Study
    Eribulin+Cyclophosphamide: ErC     Docetaxel+Cyclophosphamide: TC  
STARTED     54 [1]   22  
COMPLETED     46 [2]   15  
NOT COMPLETED     8     7  
MD Discretion/Lack of Efficacy                 3                 4  
Disease Progression                 4                 1  
Adverse Event                 1                 1  
Death                 0                 1  
[1] Includes 10 patients from safety lead-in.
[2] Patients who completed 6 cycles plus surgery.



  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.
Analysis population for ErC includes 10 lead-in and 44 randomized patients.

Reporting Groups
  Description
Eribulin+Cyclophosphamide (ErC)

Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard;

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard

Docetaxel+Cyclophosphamide (TC)

Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion;

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard

Total Total of all reporting groups

Baseline Measures
    Eribulin+Cyclophosphamide (ErC)     Docetaxel+Cyclophosphamide (TC)     Total  
Number of Participants  
[units: participants]
  54     22     76  
Age  
[units: years]
Median (Full Range)
  53  
  (23 to 77)  
  51  
  (38 to 73)  
  52  
  (23 to 77)  
Gender  
[units: participants]
     
Female     54     22     76  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     54     22     76  



  Outcome Measures
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1.  Primary:   Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery   [ Time Frame: 18 weeks ]

2.  Secondary:   The Number of Adverse Events as a Measure of Safety and Tolerability.   [ Time Frame: 43 months ]

3.  Secondary:   Clinical Response Rate (cRR) of ErC as Neoadjuvant Therapy   [ Time Frame: 43 months ]

4.  Secondary:   Disease-Free Survival (DFS) at 2 Years   [ Time Frame: 24 months ]


  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
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01527487     History of Changes
Other Study ID Numbers: SCRI BRE 197
Study First Received: January 31, 2012
Results First Received: March 18, 2016
Last Updated: July 15, 2016
Health Authority: United States: Institutional Review Board