Metastatic Breast Cancer
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGIcotinib
Icotinib 125 mg BID
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 36 months | the time from randomization to the date of disease progression or death from any causes |
Countries
China
Outcome results
None listed