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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Terminated
CT.gov ID
NCT02362230
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
71.5
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sun Yat-sen University Cancer Center
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

Icotinib 125 mg BID

Drug: Icotinib
Icotinib 125 mg BID
Other Names:
  • Conmana

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [36 months]

      the time from randomization to the date of disease progression or death from any causes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University, Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Zhong-Yu Yuan, M.D., Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT02362230
    Other Study ID Numbers:
    • SYSUCC-006
    First Posted:
    Feb 12, 2015
    Last Update Posted:
    Jan 29, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jan 29, 2021