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

Sponsor

Liaoning Tumor Hospital & Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT02030678

Collaborator

(none)

124

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

N/A

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 :

Sep 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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 Names: Kaiputuo

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 Names:

Kaiputuo

Outcome Measures

Primary Outcome Measures

Disease Control Rate [3cycles (21days/cycle)]
Disease Control Rate:Completely Response+Partial Response+Stable Disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Heart Disease.etc

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SunTao	Shenyang	Liaoning	China	110000

Sponsors and Collaborators

Liaoning Tumor Hospital & Institute

Investigators

Principal Investigator: Tao Sun, Doctor, Liaoning Tumor Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Tao, Director of Oncology, Liaoning Tumor Hospital & Institute

ClinicalTrials.gov Identifier:

NCT02030678

Other Study ID Numbers:

STao

First Posted:

Jan 8, 2014

Last Update Posted:

Sep 5, 2018

Last Verified:

Sep 1, 2018

Additional relevant MeSH terms:

Breast Neoplasms

Recurrence

Irinotecan

Study Results

No Results Posted as of Sep 5, 2018