Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy

Sun Yat-sen University Cancer Center

Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.

This is a phase II, multi-center study. Sixty-seven patients are planned to be enrolled. All patients will receive Icotinib 125 mg BID administered for 8 weeks. Patients with a complete response, partial response or stable disease at that time may continue to be treated based on physician discretion. Follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.

Inclusion Criteria:

• Age 18 years or older
• ECOG 0 or 1
• Primary or metastatic tumor onfirmed as triple negative
• Measurable disease per RECIST version 1.1
• normal organ function, including bone marrow function, renal function, liver function, and cardiac function
• Two or more prior chemotherapy
• signed and dated an informed consent form
• Life expectancy of at least 12 weeks

Exclusion Criteria:

• Pregnant or breast feeding
• ECOG score ≧2
• Uncontrolled medical problems
• Hepatic, renal, or bone marrow dysfunction as detailed above
• Concurrent malignancy or history of other malignancy within the last five years except as noted above
• Patients were unable or unwilling to comply with program requirements