- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193206
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists
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Jacksonville, Florida, United States, 32256
- Integrated Community Oncology Network
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Lakeland, Florida, United States, 33805
- Watson Clinic Center for Cancer Care and Research
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Orlando, Florida, United States, 32804
- Florida Hospital Cancer Institute
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Georgia
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40207
- Consultants in Blood Disorders and Cancer
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Louisiana
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Alexandria, Louisiana, United States, 71301
- Hematology Oncology Life Center
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Maine
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Portland, Maine, United States, 04101
- Mercy Hospital
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Ohio
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care
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South Carolina
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Spartanburg, South Carolina, United States, 29303
- Spartanburg Regional Medical Center
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology and Hematology Associates
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Nashville, Tennessee, United States, 37203
- Tennessee Oncology
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Virginia
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Newport News, Virginia, United States, 23601
- Peninsula Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
Other Names:
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Other Names:
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic Complete Response
Time Frame: 18 months
|
For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection.
Residual ductal or lobular carcinoma in situ was not considered in pCR assessments.
Percentage of participants who experienced pCR is reported.
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response Rates
Time Frame: 18 months
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Clinical response rate is defined as percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment).
Clinical tumor response was defined as complete if there was no clinical evidence of palpable tumor in either the breast or axilla at the time of surgery.
Reduction of total tumor size >50 % at the time surgery was considered a clinical partial response.
Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
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18 months
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Time to Disease Progression
Time Frame: 36 months
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Time to progression is the length of time from the start of treatment until the disease progressed.
Progressive disease is defined as an increase of >25% in the total calculated product of the tumor's measurements or development of a new lesion.
Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
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36 months
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Rates of Breast Preservation
Time Frame: 18 months
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Number of patients who underwent breast conservation after neo adjuvant chemotherapy
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18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Denise A. Yardley, MD, SCRI Development Innovations, LLC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Inflammatory Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Gemcitabine
- Paclitaxel
- Epirubicin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- SCRI BRE 73
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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