Irinotecan for Advanced and Metastatic Breast Cancer

Sponsor
Liaoning Cancer Hospital & Institute
Study ID
NCT03562390
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    The patients will receive treatment using intravenous irinotecan hydrochloride until the patient develops disease progression or fulfills a withdrawal criterion.

Study Details

This trial aims to evaluate the safety and efficacy of third-line or later irinotecan treatment for locally recurrent or metastatic breast cancer among Chinese patients who have received at least two regimens containing anthracyclines and taxanes.

Key Dates

Start date
Apr 1, 2017
Status verified
Jun 2018
Primary completion
Jan 31, 2020
Completion
Dec 31, 2021

Study Design

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

Arms

  • Experimental: Experimental group
    124 women with locally recurrent or metastatic breast cancer who will receive treatment at 17 research centers in Liaoning Province and Heilongjiang Province of China. Irinotecan is administered intravenously on days 1 and 8 of each 3-week cycle.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 1 year ]

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