Metastatic Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, nab-paclitaxel, Abraxane
Brief summary
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.
Detailed 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).
Interventions
DRUGnab-paclitaxel
nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 3 years | Includes the number of participants with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response | Up to 3 years | Number of participants who achieve a response |
Countries
Austria
Outcome results
None listed