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

Sun Yat-sen University Cancer Center

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Icotinib

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University, Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib; Icotinib 125 mg BID	Drug: Icotinib; Icotinib 125 mg BID; Other Names: Conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	the time from randomization to the date of disease progression or death from any causes	36 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: February 8, 2015
• First Submitted That Met QC Criteria: February 8, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SYSUCC-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO