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Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Pharmacia and Upjohn
Eli Lilly and Company
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193050
First received: September 12, 2005
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
Results First Received: August 22, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Gemcitabine
Drug: Epirubicin
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention

In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles

Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.

After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.

After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.

Participant Flow for 3 periods

 Period 1:   Neoadjuvant Treatment
    Intervention  
STARTED     110  
COMPLETED     101  
NOT COMPLETED     9  
Lack of Efficacy                 2  
Intercurrent Illness                 3  
Physician Decision                 2  
Adverse Event                 2  

Period 2:   Surgery
    Intervention  
STARTED     103 [1]
COMPLETED     103  
NOT COMPLETED     0  
[1] 2 patients had surgery after 2 cycles of neoadjuvant treatment

Period 3:   Adjuvant
    Intervention  
STARTED     87 [1]
COMPLETED     77  
NOT COMPLETED     10  
Physician Decision                 5  
Intercurrent Hospitalization                 3  
Lack of Efficacy                 2  
[1] 16 patients never initiated postoperative adjuvant therapy



  Baseline Characteristics
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Reporting Groups
  Description
Intervention

In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles

Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.

After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.

After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.

Baseline Measures
    Intervention  
Number of Participants  
[units: participants]
 		  110  
Age  
[units: years]
Median ( Full Range ) 		  51  
  ( 27 to 75 )  
Gender  
[units: participants]
 		 
Female     110  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     110  



  Outcome Measures

1.  Primary:   Pathologic Complete Response (pCR)   [ Time Frame: 18 Months ]
  Show Outcome Measure 1

2.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: 69 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 48 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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 of Results:


Responsible Party: Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00193050     History of Changes
Other Study ID Numbers: SCRI BRE 51
Study First Received: September 12, 2005
Results First Received: August 22, 2012
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board