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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Zhong-yu Yuan, Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02362230
First received: February 8, 2015
Last updated: December 19, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Metastatic Breast Cancer Drug: Icotinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sun Yat-sen University Cancer Center

Resource links provided by NLM:


Further study details as provided by Zhong-yu Yuan, Sun Yat-sen University:

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

Estimated Enrollment: 67
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Icotinib
Icotinib 125 mg BID
Drug: Icotinib
Icotinib 125 mg BID
Other Name: Conmana

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02362230

Contacts
Contact: Zhong-Yu Yuan, M.D. 86-20-87343794 yuanzhy@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University, Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yuan Zhong-yu, MD    86-20-87343347    yuanzhygz@163.com   
Contact: Wang Xi, MD    86-20-62354672    wangxi@sysucc.org.cn   
Sub-Investigator: Yuan Zhong-yu, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Zhong-Yu Yuan, M.D. Sun Yat-sen University
  More Information

Responsible Party: Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02362230     History of Changes
Other Study ID Numbers: SYSUCC-006
Study First Received: February 8, 2015
Last Updated: December 19, 2016
Individual Participant Data  
Plan to Share IPD: Yes

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

ClinicalTrials.gov processed this record on June 23, 2017