Abraxane in Treatment of Metastatic Breast Cancer

Celgene

Status: Completed

Conditions: Metastatic Breast Cancer

Treatments: Drug: nab-paclitaxel

Study type: Observational

Funder types: Industry

Identifiers

NCT02555696

NIPMS-Celgene-AUT-002

Details and patient eligibility

About

This observational project is collecting tolerability, safety and efficacy data with the routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on the dosage of Abraxane and general data on the disease and the health status of the patient will be collected.

Full description

This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labelled indication in metastatic breast cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.

A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.

This data might also be supportive for further treatment optimization of Abraxane in Metastatic Breast Cancer (MBC).

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC)
2. Signed Informed Consent
3. Participants > 18 Years of Age

Exclusion criteria

1. Pregnant or lactating females
2. Neutrophils <1.5 X 10^9/L
3. Hypersensivity to nab-paclitaxel

Trial design

203 participants in 1 patient group

nab-paclitaxel

Description:

nab-paclitaxel 260mg/m\^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity

Treatment:

Drug: nab-paclitaxel