Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
NCT ID: NCT00193206
Last Updated: 2021-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2005-09-30
2009-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.
Gemcitabine
Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Epirubicin
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Albumin-bound Paclitaxel
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Interventions
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Gemcitabine
Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Epirubicin
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Albumin-bound Paclitaxel
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Celgene Corporation
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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Denise A. Yardley, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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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
Countries
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References
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Yardley DA, Zubkus J, Daniel B, Inhorn R, Lane CM, Vazquez ER, Naot Y, Burris HA 3rd, Hainsworth JD. A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer. Clin Breast Cancer. 2010 Oct 1;10(5):367-72. doi: 10.3816/CBC.2010.n.048.
Other Identifiers
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SCRI BRE 73
Identifier Type: -
Identifier Source: org_study_id
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