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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
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention
Hide Arm/Group Description

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

Period Title: Preoperative Therapy
Started 123
Completed 116
Not Completed 7
Reason Not Completed
Lack of Efficacy             2
Adverse Event             2
Withdrawal by Subject             2
False Positive Pregnancy Test             1
Period Title: Surgery
Started 116
Completed 116
Not Completed 0
Period Title: Postoperative Therapy
Started 116
Completed 102
Not Completed 14
Reason Not Completed
Withdrawal by Subject             7
Physician Decision             3
Intercurrent Illness             2
Lack of Efficacy             1
Protocol Violation             1
Arm/Group Title Intervention
Hide Arm/Group Description

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

Overall Number of Baseline Participants 123
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 123 participants
51
(29 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants
Female
123
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 123 participants
123
1.Primary Outcome
Title Pathologic Complete Response
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:

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

Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: participants
23
2.Secondary Outcome
Title Clinical Response Rates
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to Disease Progression
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Rates of Breast Preservation
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention
Hide Arm/Group Description

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

All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention
Affected / at Risk (%) # Events
Total   22/123 (17.89%)    
Cardiac disorders   
Cardiac Ischemia/Infarction  1 [1]  1/123 (0.81%)  1
Pain - Chest  1  2/123 (1.63%)  2
Gastrointestinal disorders   
Dehydration  1  2/123 (1.63%)  2
General disorders   
Death  1 [2]  1/123 (0.81%)  1
Weakness  1  1/123 (0.81%)  1
Hepatobiliary disorders   
Pain - Liver  1  1/123 (0.81%)  1
Infections and infestations   
Infection - Skin  1 [3]  3/123 (2.44%)  3
Infection - Gastrointestinal  1 [4]  1/123 (0.81%)  1
Infection - Vein  1 [5]  2/123 (1.63%)  2
Infection - Pneumonia  1  1/123 (0.81%)  1
Infection - Skin  1 [6]  3/123 (2.44%)  4
Musculoskeletal and connective tissue disorders   
Fracture  1  2/123 (1.63%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death  1 [7]  1/123 (0.81%)  1
Psychiatric disorders   
Neurology - Other  1 [8]  1/123 (0.81%)  1
Vascular disorders   
Thrombosis/Thrombus/Embolism  1  2/123 (1.63%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Angina
[2]
Intercurrent Illness
[3]
Cellulitis
[4]
Colitis
[5]
Septic Thrombophlebitis
[6]
Port Site Infection
[7]
Progressive Disease
[8]
Suicidal Ideations
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   41/123 (33.33%)    
Blood and lymphatic system disorders   
Neutrophils  1 [1]  13/123 (10.57%) 
Platelets  1 [2]  7/123 (5.69%) 
General disorders   
Fatigue  1  7/123 (5.69%) 
Musculoskeletal and connective tissue disorders   
Arthralgia/Myalgia  1  8/123 (6.50%) 
Vascular disorders   
Thrombosis/Thrombus/Embolism  1  6/123 (4.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Neutropenia
[2]
Thrombocytopenia
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: 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