Breast Cancer Clinical Trial
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
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 triplet.
Full 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 + Pegfilgrastim
Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim
Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.
Eligibility Criteria
Inclusion Criteria:
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
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Exclusion Criteria:
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.
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There are 13 Locations for this study
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32256, United States
Lakeland Florida, 33805, United States
Orlando Florida, 32804, United States
Gainesville Georgia, 30501, United States
Louisville Kentucky, 40207, United States
Alexandria Louisiana, 71301, United States
Portland Maine, 04101, United States
Cincinnati Ohio, 45242, United States
Spartanburg South Carolina, 29303, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Newport News Virginia, 23601, United States
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