Clinical trial NCT01689610: Non-interventional Study With Nab-Paclitaxel (Abraxane®)
Official title: Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Nab-Paclitaxel
Abraxane
Nabucco
safety
breast cancer
daily routine
peripheral neuropathy
iOMEDICO
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 705
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with metastatic breast cancer

Brief summary: The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.

Detailed description: 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?

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: 6 months after last-patient-in (LPI)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 6 months after last-patient-in (LPI)
measure: Overall survival (OS)
timeFrame: 6 months after last-patient-in (LPI)
measure: Time to treatment discontinuation
timeFrame: 6 months after last-patient-in (LPI)
measure: Number of participants with Adverse Events as a measure of safety and tolerability
timeFrame: Until 30 days after discontinuation of Nab-paclitaxel
measure: Relative dosage of Nab-Paclitaxel
timeFrame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Intensity of peripheral neuropathy
timeFrame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Occurence of neutropenia
timeFrame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics)
timeFrame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Patient reported outcome on Quality of life and adverse events
timeFrame: At baseline, 3 and 6 months after start of treatment
measure: Reasons for dose modifications or discontinuation of treatment
timeFrame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Occurence of febrile neutropenia
timeFrame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Occurence of peripheral neuropathy
timeFrame: Until discontinuation of Nab-Paclitaxel, up to 6 month
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO AG
state: Baden-Wuerttemberg
Study officials:
affiliation: Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany
name: Christoph Salat, Prof.
role: PRINCIPAL_INVESTIGATOR
References: