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

NCT02362230 | Terminated Phase 2 DMC

• 1 other identifier: SYSUCC-006
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

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

  36 months

Study Arms (1)

Icotinib

EXPERIMENTAL

Icotinib 125 mg BID

Drug: Icotinib

Interventions

Icotinib DRUG

Icotinib 125 mg BID

Also known as: Conmana

Icotinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

icotinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhong-Yu Yuan, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: February 12, 2015
• Study Start: January 1, 2015
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)