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

Metastatic Breast Cancer Clinical Trial

Official title:

Sun Yat-sen University Cancer Center

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02362230
• Other study ID #: SYSUCC-006
• Status: Terminated
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: December 15, 2020

Study information

• Verified date: January 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Icotinib
Icotinib 125 mg BID

Locations

Country	Name	City	State
China	Sun Yat-sen University, Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	the time from randomization to the date of disease progression or death from any causes	36 months