Spots Global Cancer Trial Database for Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
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Trial Identification
Brief Title: Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Official Title: Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Study ID: NCT00193206
Conditions
Study Description
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 triplet.
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 + 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Florida Cancer Specialists, Fort Myers, Florida, United States
Integrated Community Oncology Network, Jacksonville, Florida, United States
Watson Clinic Center for Cancer Care and Research, Lakeland, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Consultants in Blood Disorders and Cancer, Louisville, Kentucky, United States
Hematology Oncology Life Center, Alexandria, Louisiana, United States
Mercy Hospital, Portland, Maine, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Chattanooga Oncology and Hematology Associates, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Peninsula Cancer Institute, Newport News, Virginia, United States
Contact Details
Name: Denise A. Yardley, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
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