Status:
COMPLETED
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Eli Lilly and Company
Celgene Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this ...
Detailed Description
Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen: Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegf...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Locally advanced/inflammatory adenocarcinoma of the breast
- 18 years of age or older
- Normal heart function
- Able to perform activities of daily living with minimal assistance
- No prior chemotherapy for breast cancer
- Adequate bone marrow, liver and kidney function
- No evidence or history of significant cardiovascular abnormalities
- Sentinel node or axillary dissection
- Sign an informed consent form
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Pregnant or breast feeding
- History of heart disease with congestive heart failure
- Heart attack within the previous 6 months
- Prior chemotherapy or hormone therapy for breast cancer
- History of active uncontrolled infection
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00193206
Start Date
September 1 2005
End Date
May 1 2009
Last Update
November 23 2021
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
3
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
4
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804