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.

View Full Description

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.

View Eligibility Criteria

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
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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

123

Study ID:

NCT00193206

Recruitment Status:

Completed

Sponsor:

SCRI Development Innovations, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 13 Locations for this study

See Locations Near You

Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Integrated Community Oncology Network
Jacksonville Florida, 32256, United States
Watson Clinic Center for Cancer Care and Research
Lakeland Florida, 33805, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Consultants in Blood Disorders and Cancer
Louisville Kentucky, 40207, United States
Hematology Oncology Life Center
Alexandria Louisiana, 71301, United States
Mercy Hospital
Portland Maine, 04101, United States
Oncology Hematology Care
Cincinnati Ohio, 45242, United States
Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Chattanooga Oncology and Hematology Associates
Chattanooga Tennessee, 37404, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Peninsula Cancer Institute
Newport News Virginia, 23601, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

123

Study ID:

NCT00193206

Recruitment Status:

Completed

Sponsor:


SCRI Development Innovations, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider