NCT02030678

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

5.3 years

First QC Date

January 7, 2014

Last Update Submit

September 1, 2018

Conditions

Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Disease Control Rate

    Disease Control Rate:Completely Response+Partial Response+Stable Disease

    3cycles (21days/cycle)

Study Arms (1)

irinotecan Hydrochloride

EXPERIMENTAL

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

Interventions

irinotecanDRUG

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.

Also known as: Kaiputuo
irinotecan Hydrochloride

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Heart Disease.etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SunTao

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

RecurrenceBreast Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Tao Sun, Doctor

    Liaoning Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Sun, Doctor

CONTACT

jianong@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Oncology

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 8, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

CN(1)