Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00193206

Run by

SCRI Development Innovations, LLC

People needed

123

Starts

2005-09-01

Expected to finish

2009-05-01

Last updated by the study team

2021-11-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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