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Nabucco - Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

Nabucco - Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer


The main focus of this non-interventional study is set on answering the following questions:

- Can the results observed in controlled clinical trials regarding efficacy and safety be
reproduced in the routine clinical setting?

- Are the side-effects of nab-paclitaxel therapy observed in this study comparable to the
previously described safety-profile in terms of frequency and intensity?

- What are the main reasons for modification or termination of the nab-paclitaxel
therapy?

- How does nab-paclitaxel therapy influence the patients' quality of life?

- What are the criteria for selecting nab-paclitaxel as therapy for metastatic breast
cancer?


Inclusion Criteria:



- Female Patients with metastatic breast cancer, who are at least 18 years old (no
upper age limit)

Exclusion Criteria:

- Contraindication according to the summary of product characteristics of Abraxane®

- No signed patient informed consent form available

- pregnant or breastfeeding patients.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time to Tumor Progression (TTP)

Outcome Time Frame:

6 months after last-patient-in (LPI)

Safety Issue:

No

Principal Investigator

Christoph Salat, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

IOM-02240

NCT ID:

NCT01689610

Start Date:

April 2012

Completion Date:

April 2015

Related Keywords:

  • Metastatic Breast Cancer
  • Nab-Paclitaxel
  • Abraxane
  • Nabucco
  • safety
  • breast cancer
  • daily routine
  • peripheral neuropathy
  • iOMEDICO
  • Breast Neoplasms

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