Non-interventional Study With Nab-Paclitaxel (Abraxane®) (NABUCCO)
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ClinicalTrials.gov Identifier: NCT01689610 |
Recruitment Status :
Completed
First Posted : September 21, 2012
Last Update Posted : June 20, 2018
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Condition or disease |
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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?
Study Type : | Observational |
Actual Enrollment : | 705 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | March 2016 |

Group/Cohort |
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Adult female patients with MBC
This is an observational study, no interventions are specified
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- Time to Tumor Progression (TTP) [ Time Frame: 6 months after last-patient-in (LPI) ]
- Overall Response Rate (ORR) [ Time Frame: 6 months after last-patient-in (LPI) ]
- Overall survival (OS) [ Time Frame: 6 months after last-patient-in (LPI) ]
- Time to treatment discontinuation [ Time Frame: 6 months after last-patient-in (LPI) ]
- Number of participants with Adverse Events as a measure of safety and tolerability [ Time Frame: Until 30 days after discontinuation of Nab-paclitaxel ]
- Relative dosage of Nab-Paclitaxel [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]
- Intensity of peripheral neuropathy [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]
- Occurence of neutropenia [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]
- Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics) [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]
- Patient reported outcome on Quality of life and adverse events [ Time Frame: At baseline, 3 and 6 months after start of treatment ]Assessed by questionnaires FACT-G, FACT-B, FACT-Taxanes and a pain questionnaire of the Robert-Koch-Institute.
- Reasons for dose modifications or discontinuation of treatment [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]
- Occurence of febrile neutropenia [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]
- Occurence of peripheral neuropathy [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689610
Germany | |
iOMEDICO AG | |
Freiburg, Baden-Wuerttemberg, Germany, 79108 |
Principal Investigator: | Christoph Salat, Prof. | Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany |
Responsible Party: | iOMEDICO AG |
ClinicalTrials.gov Identifier: | NCT01689610 |
Other Study ID Numbers: |
IOM-02240 |
First Posted: | September 21, 2012 Key Record Dates |
Last Update Posted: | June 20, 2018 |
Last Verified: | June 2018 |
Nab-Paclitaxel Abraxane Nabucco safety |
breast cancer daily routine peripheral neuropathy iOMEDICO |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |