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

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ClinicalTrials.gov Identifier: NCT00193050
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : September 21, 2012
Last Update Posted : September 21, 2012
Sponsor:
Collaborators:
Pharmacia and Upjohn
Eli Lilly and Company
Aventis Pharmaceuticals
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: Docetaxel
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention
Hide Arm/Group Description

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.

Period Title: Neoadjuvant Treatment
Started 110
Completed 101
Not Completed 9
Reason Not Completed
Lack of Efficacy             2
Intercurrent Illness             3
Physician Decision             2
Adverse Event             2
Period Title: Surgery
Started 103 [1]
Completed 103
Not Completed 0
[1]
2 patients had surgery after 2 cycles of neoadjuvant treatment
Period Title: Adjuvant
Started 87 [1]
Completed 77
Not Completed 10
Reason Not Completed
Physician Decision             5
Intercurrent Hospitalization             3
Lack of Efficacy             2
[1]
16 patients never initiated postoperative adjuvant therapy
Arm/Group Title Intervention
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 110
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 110 participants
51
(27 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female
110
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants
110
1.Primary Outcome
Title Pathologic Complete Response (pCR)
Hide Description [Not Specified]
Time Frame 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18
(11 to 26)
2.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description [Not Specified]
Time Frame 69 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame 48 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention
Hide Arm/Group Description

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.

All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention
Affected / at Risk (%) # Events
Total   17/110 (15.45%)    
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/110 (0.91%)  1
Gastrointestinal disorders   
Esophagitis  1  1/110 (0.91%)  1
Dysphagia  1  1/110 (0.91%)  1
Nausea/Vomiting  1  1/110 (0.91%)  1
Nausea  1  1/110 (0.91%)  1
General disorders   
Fever  1  1/110 (0.91%)  1
Infections and infestations   
Febrile Neutropenia  1  11/110 (10.00%)  15
Infection - Other  1 [2]  1/110 (0.91%)  1
Infection - Pneumonia  1  1/110 (0.91%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/110 (1.82%)  2
Hypoxia  1  1/110 (0.91%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Anemia
[2]
Fatal Legionnaire's disease
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention
Affected / at Risk (%) # Events
Total   71/110 (64.55%)    
Blood and lymphatic system disorders   
Neutrophils  1 [1]  45/110 (40.91%) 
Platelets  1 [2]  19/110 (17.27%) 
Hemoglobin  1 [3]  13/110 (11.82%) 
Gastrointestinal disorders   
Nausea  1  14/110 (12.73%) 
Vomiting  1  10/110 (9.09%) 
Diarrhea  1  5/110 (4.55%) 
General disorders   
Fatigue  1  10/110 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Neutropenia
[2]
Thrombocytopenia
[3]
Anemia
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 sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 877-691-7274
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193050     History of Changes
Other Study ID Numbers: SCRI BRE 51
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: August 22, 2012
Results First Posted: September 21, 2012
Last Update Posted: September 21, 2012