Back to resultsA Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer
Primary Purpose
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Mestatic breast cancer patients whose disease recurrent after using anthracycline or taxane drugs
Exclusion Criteria:
- Heart Disease.etc
Sites / Locations
- SunTaoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
irinotecan Hydrochloride
Arm Description
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.
Outcomes
Primary Outcome Measures
Disease Control Rate
Disease Control Rate:Completely Response+Partial Response+Stable Disease
Secondary Outcome Measures
Full Information
NCT ID
NCT02030678
First Posted
January 7, 2014
Last Updated
September 1, 2018
Sponsor
Liaoning Tumor Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT02030678
Brief Title
A Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaoning Tumor Hospital & Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
irinotecan Hydrochloride
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
irinotecan
Other Intervention Name(s)
Kaiputuo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease Control Rate
Description
Disease Control Rate:Completely Response+Partial Response+Stable Disease
Time Frame
3cycles (21days/cycle)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mestatic breast cancer patients whose disease recurrent after using anthracycline or taxane drugs
Exclusion Criteria:
Heart Disease.etc
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Sun, Doctor
Email
jianong@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Sun, Doctor
Organizational Affiliation
Liaoning Tumor Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
SunTao
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Sun, Doctor
Email
jianong@126.com
First Name & Middle Initial & Last Name & Degree
Tao Sun, Doctor
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer
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