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

• Status: Terminated
• Trial end date: 2020-12-15
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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