- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02030678
A Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer
September 1, 2018 updated by: Sun Tao, Liaoning Tumor Hospital & Institute
To Evaluate the Clinical Effect of Irinotecan Monotherapy in Treatment of Local Recurrence or Metastatic Breast Cancer Patients Who Accepted at Least 2 Kinds of Chemotherapy Regimens Including Antharcycline or Taxanes.
A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer.
Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs.
The primary endpoint is Disease Control Rate and Progression free survival.
The second endpoint is 3 or 4 grade Adverse Events 、overall survival.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer.
Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs.
The primary endpoint is Disease Control Rate and Progression free survival.
The second endpoint is 3 or 4 grade Adverse Events 、overall survival.
irinotecan 100mg/m2,iv,day1,day8,every 3cycles.If no AE happens, increase irinotecan dose to125mg/m2 at the second cycle.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.
Study Type
Interventional
Enrollment (Anticipated)
124
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tao Sun, Doctor
- Email: jianong@126.com
Study Locations
-
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Liaoning
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Shenyang, Liaoning, China, 110000
- Recruiting
- SunTao
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Principal Investigator:
- Tao Sun, Doctor
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Contact:
- Tao Sun, Doctor
- Email: jianong@126.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mestatic breast cancer patients whose disease recurrent after using anthracycline or taxane drugs
Exclusion Criteria:
- Heart Disease.etc
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: irinotecan Hydrochloride
Irinotecan monotherapy (trade name: Aili; batches 180103AG [40 mg] and 171231AG [100 mg]) will be administered intravenously at a dose of 100 mg/m2 on days 1 and 8 of each 3-week cycle.
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Irinotecan monotherapy (trade name: Aili; batches 180103AG [40 mg] and 171231AG [100 mg]) will be administered intravenously at a dose of 100 mg/m2 on days 1 and 8 of each 3-week cycle.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate
Time Frame: 3cycles (21days/cycle)
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Disease Control Rate:Completely Response+Partial Response+Stable Disease
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3cycles (21days/cycle)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tao Sun, Doctor, Liaoning Tumor Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
January 7, 2014
First Submitted That Met QC Criteria
January 7, 2014
First Posted (Estimate)
January 8, 2014
Study Record Updates
Last Update Posted (Actual)
September 5, 2018
Last Update Submitted That Met QC Criteria
September 1, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STao
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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