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A Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02030678
Recruitment Status : Recruiting
First Posted : January 8, 2014
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Tao, Liaoning Tumor Hospital & Institute

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.

Condition or disease Intervention/treatment Phase
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer Drug: irinotecan Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.
Drug: irinotecan
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 Name: Kaiputuo




Primary Outcome Measures :
  1. Disease Control Rate [ Time Frame: 3cycles (21days/cycle) ]
    Disease Control Rate:Completely Response+Partial Response+Stable Disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mestatic breast cancer patients whose disease recurrent after using anthracycline or taxane drugs

Exclusion Criteria:

  • Heart Disease.etc

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030678


Contacts
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Contact: Tao Sun, Doctor jianong@126.com

Locations
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China, Liaoning
SunTao Recruiting
Shenyang, Liaoning, China, 110000
Contact: Tao Sun, Doctor       jianong@126.com   
Principal Investigator: Tao Sun, Doctor         
Sponsors and Collaborators
Liaoning Tumor Hospital & Institute
Investigators
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Principal Investigator: Tao Sun, Doctor Liaoning Tumor Hospital & Institute

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Responsible Party: Sun Tao, Director of Oncology, Liaoning Tumor Hospital & Institute
ClinicalTrials.gov Identifier: NCT02030678     History of Changes
Other Study ID Numbers: STao
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Irinotecan
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents