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

Sun Yat-sen University

Status and phase

Terminated

Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Drug: Icotinib

Study type

Interventional

Funder types

Other

Identifiers

NCT02362230

SYSUCC-006

Details and patient eligibility

About

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.

Full description

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.

Enrollment

26 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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