Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Phase 2CompletedNCT01019577

R-Pharm54 enrolled

Overview

The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

IxabepiloneDRUG

Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 20 years or older * Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination Exclusion Criteria: * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2

Outcomes

Primary Outcomes

To assess the tumor response using RECIST Criteria to determine the best overall response and response rate

Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

Secondary Outcomes

To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria

Time frame: Every cycle

To evaluate the duration of achieved responses

Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

To evaluate time to progression (TTP)

Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

Data from ClinicalTrials.gov

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