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

Sponsor
Liaoning Cancer Hospital & Institute
Study ID
NCT02030678
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • irinotecan — DRUG
    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 Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Sep 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2020

Study Design

Enrollment
124 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Disease Control Rate [ Time Frame: 3cycles (21days/cycle) ]

Central Contacts