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Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI BRE 73

NCT ID:

NCT00193206

Start Date:

September 2005

Completion Date:

May 2009

Related Keywords:

  • Breast Cancer
  • Locally Advanced Breast Cancer
  • Inflammatory Breast Cancer
  • Breast Cancer
  • Abraxane
  • nab Paclitaxel
  • Epirubicin
  • Gemcitabine
  • Gemzar
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms

Name

Location

Florida Hospital Cancer InstituteOrlando, Florida  32804
Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Peninsula Cancer InstituteNewport News, Virginia  23601
Mercy HospitalPortland, Maine  04101
Chattanooga Oncology and Hematology AssociatesChattanooga, Tennessee  37404
Hematology Oncology Life CenterAlexandria, Louisiana  71301
Tennessee OncologyNashville, Tennessee  37203
Oncology Hematology CareCincinnati, Ohio  45242
Watson Clinic Center for Cancer Care and ResearchLakeland, Florida  33805