Breast Cancer Clinical Trial
A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer
This is a Phase 2, multicenter, open-label, noncomparative study to evaluate safety,efficacy and of single-agent EZN 2208 administered in patients with previously treated MBC.
After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival.
EZN-2208 will be administered by i.v. infusion weekly for 3 weeks in 4-week cycles. Study treatment will be continued until evidence of disease progression, unacceptable toxicity, or withdrawal of the patient's consent for participation in the study.
Approximately 160 patients with previously treated MBC will be enrolled in this study. Eighty patients in each of two cohorts will be evaluated as follows:
AT Cohort - Patients treated with prior anthracycline and taxane as adjuvant or metastatic therapy; no more than 2 prior chemotherapy regimens for MBC
ATX Cohort - Patients treated with prior anthracycline, taxane, and XelodaÂ® (capecitabine) as adjuvant or metastatic therapy; no more than 4 prior chemotherapy regimens for MBC
After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival for at least 6 months after enrollment of the last patient in the study
Histologically confirmed breast adenocarcinoma that is metastatic. Receptor status of the tumor must be known.
Disease progression during or after immediate previous therapy, or intolerable toxicity leading to cessation of immediate previous therapy
Previous treatment for MBC:
AT Cohort: Prior AT required as adjuvant or metastatic therapy; no more than 2 prior chemotherapy regimens for MBC.
ATX Cohort: Prior ATX required as adjuvant or metastatic therapy;no more than 4 prior chemotherapy regimens for MBC.
For patients with positive receptor status:
Patients with HER2+ MBC must have received prior trastuzumab.
Patients with ER+ MBC must have received prior hormone therapy.
Measurable disease by RECIST Version 1.1
Women 18 years or older
ECOG performance status of 0 to 2
Adequate bone marrow, renal and hepatic functions
Major surgery within 3 weeks before study start
Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy
Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks before scheduled administration of EZN-2208
History of other primary cancer within 5 years of enrollment, unless
Curatively resected non-melanomatous skin cancer, or
Curatively resected cervical cancer
Lack of recovery to Grade 1 from any reversible side effects related to the administration of an investigational agent, chemotherapy, or other prior treatments for the cancer
Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an approved drug) in the 30 days before the first administration of EZN-2208
Known chronic infectious disease, such as AIDS
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There are 36 Locations for this study
Sedona Arizona, 86336, United States
Tucson Arizona, 85704, United States
Murrieta California, 92562, United States
Oxnard California, 93030, United States
Denver Colorado, 80220, United States
New Port Richey Florida, 34655, United States
Ocoee Florida, 34761, United States
Niles Illinois, 60714, United States
Carmel Indiana, 46032, United States
Minneapolis Minnesota, 55404, United States
Columbia Missouri, 65201, United States
Kansas City Missouri, 64131, United States
Henderson Nevada, 89074, United States
Troy New York, 12180, United States
Raleigh North Carolina, 27607, United States
Columbus Ohio, 43219, United States
Portland Oregon, 97213, United States
Greenville South Carolina, 29605, United States
Abilene Texas, 79606, United States
Arlington Texas, 76014, United States
Austin Texas, 78705, United States
Bedford Texas, 76022, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Dallas Texas, 75237, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Lewisville Texas, 75067, United States
McAllen Texas, 78503, United States
Midland Texas, 79701, United States
Sugar Land Texas, 77479, United States
Tyler Texas, 75702, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Salem Virginia, 24153, United States
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