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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Celgene Corporation; Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Epirubicin; Gemcitabine; Paclitaxel

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

• Sign an informed consent form

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.