A Phase II Study of E7389 in Patients With Breast Cancer, Previously Treated With Anthracycline, Taxane and Capecitabine
- Registration Number
- NCT00246090
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who are refractory to the last prior therapy for their disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 298
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Female patients with histologically or cytologically confirmed carcinoma of the breast. Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.
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Patients with locally advanced or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least one of which was administered for treatment of locally advanced or metastatic disease.
Prior therapy must be documented by the following criteria prior to entry onto study:
- Regimens must have included an anthracycline (eg, doxorubicin, epirubicin), a taxane (eg, paclitaxel, docetaxel) and capecitabine in any combination or order.
- One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy.
- Patients with human epidermal growth factor receptor 2 (HER2/neu) over-expressing tumors must additionally have been treated with trastuzumab.
- Patients with estrogen receptor-expressing tumors may have additionally been treated with estrogen-specific therapy.
- Prior hormonal therapy, biological therapy, (eg, trastuzumab, bevacizumab), or immunotherapy, is not to be counted as one of the 2 to 5 prior chemotherapy regimens allowed. However, hormonal therapy must be discontinued one week before administration of E7389, and biological therapy must be discontinued two weeks before E7389 administration.
- Patients who are being treated with bisphosphonates when they enter the study are allowed to continue the medication as long as the dosing does not change. In case a change in dosing is deemed necessary, the case needs to be discussed with the Sponsor.
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Progression on or within six months of the last regimen for advanced disease, documented by the following:
- The dates of treatment, doses, outcome of therapy and the reason for discontinuation of prior anthracycline, taxane, capecitabine, and trastuzumab therapy must be provided.
- Prior to entry onto the study, information ensuring that the last therapy fulfills eligibility criteria is required, which includes progression while receiving this last prior chemotherapy regimen, or within six months of receiving that therapy.
- Chemotherapy medication administration sheets or other official medical/hospital records indicating type and dates of chemotherapy must be available for inspection, and one of the following as a reason for discontinuation of medication is required: radiographic evidence of progression, or doctor's office or hospitalization notes documenting radiologic progression, clinically documented increase in tumor burden, and/or increase in tumor-specific markers.
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Patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter [LD] by spiral computer tomography [CT] scan), or at least 20 mm by standard techniques. If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a biopsy or aspiration with cytological or histological confirmation of the diagnosis of breast carcinoma is required.
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Resolution of all chemotherapy or radiation-related toxicities to less than Grade 2 severity, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
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Age >= 18 years.
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Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
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Life expectancy of ≥ 3 months.
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Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 40 mL/minute (min) per the Cockcroft and Gault formula.
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Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x 10^9/L hemoglobin ≥ 10.0 g/dL (acceptable if it is corrected by therapeutic intervention or transfusional support), and platelet count ≥ 100 x 10^9/L.
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Adequate liver function as evidenced by bilirubin ≤ 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) ≤ 3 times the upper limits of normal (ULN) (in the case of liver metastases ≤ 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.
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Willing and able to complete the European Organization for Research on the Treatment of Cancer (EORTC) quality of life assessment, Analgesic Diary, and Pain Visual Analog Scale (VAS).
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Willing and able to comply with the study protocol for the duration of the study.
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Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
- Patients must not have received chemotherapy, radiation, or biologic therapy within two weeks, hormonal therapy within one week, or trastuzumab within three weeks, before E7389 treatment start.
- Patients must not have received radiation therapy encompassing > 30% of marrow (a lesion that has been irradiated cannot be used as a target lesion, unless it has progressed after the irradiation).
- Patients must not have pre-existing neuropathy > Grade 2.
- Patients must not have participated in a prior E7389 clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 E7389 -
- Primary Outcome Measures
Name Time Method Objective Response Rate Every two cycles Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
- Secondary Outcome Measures
Name Time Method Duration of Response From first documented complete or partial response until disease progression or death Complete response (CR) is defined as the disappearance of all lesions. Partial response (PR) is defined as 30% decrease in lesion diameter.
Trial Locations
- Locations (61)
Peachtree Hematology And Oncology Consultants
🇺🇸Atlanta, Georgia, United States
Central Indiana Cancer Center
🇺🇸Indianapolis, Indiana, United States
Texas Oncology PA
🇺🇸Houston, Texas, United States
Park Nicollet Institute
🇺🇸Minneapolis, Minnesota, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Cancer Care and Hematology Specialist of Chicagoland
🇺🇸Niles, Illinois, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Arkansas Cancer Research Center
🇺🇸Little Rock, Arkansas, United States
Hematology-Oncology Associates
🇺🇸Port Saint-Lucie, Florida, United States
Cancer Research Network
🇺🇸Plantation, Florida, United States
North Shore Hematology Oncology Associates
🇺🇸East Setakuet, New York, United States
Dr. Elizabeth Tan-Chiu, PA
🇺🇸Tamarac, Florida, United States
Willamette Valley Cancer Center
🇺🇸Eugene, Oregon, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Texas Oncology, P.A. Bedford
🇺🇸Bedford, Texas, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Centre Hospitaliere Universitaire de Montreal
🇨🇦Montreal, Quebec, Canada
Center For Oncology Research and Treatment, PA
🇺🇸Dallas, Texas, United States
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Medical University of Ohio
🇺🇸Toledo, Ohio, United States
Weill Cornell Breast Cancer Center
🇺🇸New York, New York, United States
Baylor College of Medicine, Breast Cancer Clinic
🇺🇸Houston, Texas, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Valley Oncology PA
🇺🇸Weslaco, Texas, United States
Northwest Cancer Specialist
🇺🇸Vancouver, Washington, United States
New York Oncology Hematology, P.C
🇺🇸Albany, New York, United States
El Paso Cancer Treatment Center West
🇺🇸El Paso, Texas, United States
North Texas Regional Cancer Center
🇺🇸Plano, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Hamilton Health Sciences Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Rocky Mountain Cancer Center-Midtown
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Center-Rose
🇺🇸Denver, Colorado, United States
Northwest Cancer Specialist Rose Qtr
🇺🇸Portland, Oregon, United States
Kaiser Permanente, Central Interstate Clinic, Hematology Oncology
🇺🇸Portland, Oregon, United States
Northwest Cancer Specialist Hoyt
🇺🇸Portland, Oregon, United States
McGill University, Dept. of Oncology, Clinical Research Program
🇨🇦Montreal, Quebec, Canada
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Huntington Medical Group, PC
🇺🇸Huntington Station, New York, United States
Birmingham Hematology and Oncology
🇺🇸Birmingham, Alabama, United States
Mercy Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Rocky Mountain Cancer Center
🇺🇸Littleton, Colorado, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸La Verne, California, United States
Monroe Medical Center
🇺🇸Munster, Indiana, United States
Frederick Memorial Hospital, Regional Cancer Therapy Center
🇺🇸Frederick, Maryland, United States
Montana Cancer Specialists
🇺🇸Missoula, Montana, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Raleigh Hematology Oncology Associates
🇺🇸Raleigh, North Carolina, United States
El Paso Cancer Treatment Center
🇺🇸El Paso, Texas, United States
Fairfax Northern VA Hematology Oncology PC
🇺🇸Fairfax, Virginia, United States
Sammons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
Oncology and Hematology Associates
🇺🇸Salem, Virginia, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
NW Ontario Regional Cancer Centre
🇨🇦Thunder Bay, Ontario, Canada
Northwestern Carolina Oncology And Hematology, PA
🇺🇸Hudson, North Carolina, United States
'Signal Point Hematology/Oncology, Inc.
🇺🇸Middletown, Ohio, United States
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States