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

Primary Purpose

Metastatic Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University, Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib

Arm Description

Icotinib 125 mg BID

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 8, 2015
Last Updated
January 26, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02362230
Brief Title
Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy
Official Title
Sun Yat-sen University Cancer Center
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty accruing subjects the study accrual was closed
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Icotinib 125 mg BID
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Conmana
Intervention Description
Icotinib 125 mg BID
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
the time from randomization to the date of disease progression or death from any causes
Time Frame
36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-Yu Yuan, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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