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

Phase 2

• Conditions: Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
• Interventions: Drug: irinotecan

• Registration Number: NCT02030678
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Study Start: 2014-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-01
• Last Update Posted: 2018-09-05
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

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

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Exclusion Criteria

• Heart Disease.etc

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
irinotecan Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Disease Control Rate	3cycles (21days/cycle)	Disease Control Rate:Completely Response+Partial Response+Stable Disease

Trial Locations

Locations (1)

SunTao; 🇨🇳 Shenyang, Liaoning, China