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

Phase 2

Terminated

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Icotinib

• Registration Number: NCT02362230
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-08
• Study First Submitted QC: 2015-02-08
• Study First Posted: 2015-02-12
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib	Icotinib	Icotinib 125 mg BID

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	36 months	the time from randomization to the date of disease progression or death from any causes

Trial Locations

Locations (1)

Sun Yat-sen University, Cancer Center; 🇨🇳 Guangzhou, Guangdong, China