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

NCT ID: NCT02030678

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2020-12-31

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.

Conditions

Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

irinotecan

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Kaiputuo

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Heart Disease.etc

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Sun Tao

Director of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tao Sun, Doctor

Role: PRINCIPAL_INVESTIGATOR

Liaoning Cancer Hospital & Institute

Locations

SunTao

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Sun, Doctor

Role: CONTACT

jianong@126.com

Facility Contacts

Tao Sun, Doctor

Role: primary

jianong@126.com

Other Identifiers

STao

Identifier Type: -

Identifier Source: org_study_id