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

Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02030678
• Other study ID #: STao
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Liaoning Tumor Hospital & Institute
• Contact: Tao Sun, Doctor
• Email: jianong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Heart Disease.etc

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrence
• Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
China	SunTao	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Liaoning Tumor Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate	Disease Control Rate:Completely Response+Partial Response+Stable Disease	3cycles (21days/cycle)