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

NCT ID: NCT02362230

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-12-15

Brief Summary

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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

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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.

Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Icotinib

Icotinib 125 mg BID

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

Icotinib 125 mg BID

Interventions

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Icotinib

Icotinib 125 mg BID

Intervention Type DRUG

Other Intervention Names

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Conmana

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhong-yu Yuan

Sun Yat-sen University Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhong-Yu Yuan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSUCC-006

Identifier Type: -

Identifier Source: org_study_id

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