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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):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193050
First received: September 12, 2005
Last updated: August 22, 2012
Last verified: August 2012
Results First Received: August 22, 2012  
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: Docetaxel

  Participant Flow
  Hide 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

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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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

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 
Overall Participants Analyzed 
[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 ]

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

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 48 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: 877-691-7274
e-mail: ASKSarah@scresearch.net


Publications of Results:

Responsible Party: SCRI Development Innovations, LLC
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