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

NCT02030678 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-09-05

No results posted yet for this study

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.

Conditions

  • Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Interventions

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.

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Tao Sun, Doctor · Liaoning Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02030678 on ClinicalTrials.gov