Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00193206
- Lead Sponsor
- SCRI Development Innovations, LLC
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 123
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Albumin-bound Paclitaxel 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. Intervention Gemcitabine 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. Intervention Epirubicin 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.
- Primary Outcome Measures
Name Time Method Pathologic Complete Response 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.
- Secondary Outcome Measures
Name Time Method Rates of Breast Preservation 18 months Number of patients who underwent breast conservation after neo adjuvant chemotherapy
Clinical Response Rates 18 months 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)
Time to Disease Progression 36 months 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)
Trial Locations
- Locations (13)
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Chattanooga Oncology and Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Mercy Hospital
🇺🇸Portland, Maine, United States
Watson Clinic Center for Cancer Care and Research
🇺🇸Lakeland, Florida, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Hematology Oncology Life Center
🇺🇸Alexandria, Louisiana, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Integrated Community Oncology Network
🇺🇸Jacksonville, Florida, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Consultants in Blood Disorders and Cancer
🇺🇸Louisville, Kentucky, United States