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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02362230
Recruitment Status : Recruiting
First Posted : February 12, 2015
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
Zhong-yu Yuan, 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Icotinib 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sun Yat-sen University Cancer Center
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Icotinib
Icotinib 125 mg BID
Drug: Icotinib
Icotinib 125 mg BID
Other Name: Conmana

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 36 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02362230

Contact: Zhong-Yu Yuan, M.D. 86-20-87343794

China, Guangdong
Sun Yat-sen University, Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yuan Zhong-yu, MD    86-20-87343347   
Contact: Wang Xi, MD    86-20-62354672   
Sub-Investigator: Yuan Zhong-yu, MD         
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Zhong-Yu Yuan, M.D. Sun Yat-sen University

Responsible Party: Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University Identifier: NCT02362230     History of Changes
Other Study ID Numbers: SYSUCC-006
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases