KCT0004248
Not yet recruiting
未知
Randomized, Open label, Multi-Center, Phase II Trial of Eribulin with or without SB3 (Trastuzumab-biosimilar) in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Seoul National University Hospital
- Enrollment
- 180
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults \>\=20 years old.
- •\-Pathologically documented breast cancer that:
- •is unresectable or metastatic
- •has confirmed HER2 positive expression as determinded according to American Society of Clinical Oncology \- College of American Pathologists guidelines evaluated at a central laboratory. Positivity is defined as immunohistochemistry 3 and/or FISH positive.
- •was previously treated with trastuzumab, T\-DM1, and taxane (whether in recurrent/metastatic setting or neoadjuvant/adjuvant setting).
- •Less than 4 prior lines of chemotherapy or HER2 targeted therapies for treatment in metastatic disease (\<4 treatment regimens for recurrent/metastatic disease excluding adjuvant treatments)
- •\-Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy).
- •\-Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- •\-Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months after the last dose of study treatment.
- •\-Adequate hematopoietic, renal and hepatic functions.
Exclusion Criteria
- •\-Prior treatment with eribulin
- •\-Uncontrolled or significant cardiovascular disease
- •\-History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF \<50%)
- •\-High\-risk uncontrolled arrhythmias (ventricular tachycardia, high\-grade AV\-block, supraventricular arrhythmias, prolonged QTc which are not adequately rate\-controlled)
- •\-Angina pectoris requiring antianginal medication
- •\-Clinically significant valvular heart disease
- •\-Evidence of transmural infarction on ECG
- •\-Poorly controlled hypertension (e.g. systolic \>180mm Hg or diastolic \>100mm Hg)
- •\-Pregnant or lactating women or women of childbearing potential, including women whose last menstrual period was ,12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during the study treatment period.
- •\-Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer and thyroid cancer. For other types of cancer, patients could be included if there is no evidence of disease for more than 3 years.
Outcomes
Primary Outcomes
Not specified
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