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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02030678

Enrollment

124

Registered

2014-01-08

Start date

2014-09-30

Completion date

2020-12-31

Last updated

2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

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.

Interventions

DRUGirinotecan

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Heart Disease.etc

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactTao Sun, Doctor

jianong@126.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026