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Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

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ClinicalTrials.gov Identifier: NCT00193206
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Sponsor:
Collaborators:
Eli Lilly and Company
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Gemcitabine
Drug: Epirubicin
Drug: Albumin-bound Paclitaxel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Intervention

Systemic Therapy

ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles

Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles

Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles


Participant Flow for 3 periods

Period 1:   Preoperative Therapy
    Intervention
STARTED   123 
COMPLETED   116 
NOT COMPLETED   7 
Lack of Efficacy                2 
Adverse Event                2 
Withdrawal by Subject                2 
False Positive Pregnancy Test                1 

Period 2:   Surgery
    Intervention
STARTED   116 
COMPLETED   116 
NOT COMPLETED   0 

Period 3:   Postoperative Therapy
    Intervention
STARTED   116 
COMPLETED   102 
NOT COMPLETED   14 
Withdrawal by Subject                7 
Physician Decision                3 
Intercurrent Illness                2 
Lack of Efficacy                1 
Protocol Violation                1 



  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.
No text entered.

Reporting Groups
  Description
Intervention

Systemic Therapy

ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles

Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles

Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles


Baseline Measures
   Intervention 
Overall Participants Analyzed 
[Units: Participants]
 123 
Age 
[Units: Years]
Median (Full Range)
 51 
 (29 to 82) 
Gender 
[Units: Participants]
 
Female   123 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   123 


  Outcome Measures

1.  Primary:   Pathologic Complete Response   [ Time Frame: 18 months ]

2.  Secondary:   Clinical Response Rates   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Time to Disease Progression   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Rates of Breast Preservation   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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: 877-691-7274
e-mail: ASKSARAH@scresearch.net


Publications:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193206     History of Changes
Other Study ID Numbers: SCRI BRE 73
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: August 22, 2012
Results First Posted: November 30, 2012
Last Update Posted: November 30, 2012