Metastatic Breast CancerNABUCCONCT01689610
Non-interventional Study With Nab-Paclitaxel (Abraxane®)
An observational study of Metastatic Breast Cancer, run by iOMEDICO AG at 1 site in Germany.
Trial summary
The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 705 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients with metastatic breast cancer
Who may be able to join
- Female Patients with metastatic breast cancer, who are at least 18 years old (no upper age limit)
Who cannot join
- Contraindication according to the summary of product characteristics of Abraxane®
- No signed patient informed consent form available
- pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer
The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.
Read the 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?
- Conditions
- Metastatic Breast Cancer
- Keywords
- Nab-Paclitaxel, Abraxane, Nabucco, safety, breast cancer, daily routine, peripheral neuropathy, iOMEDICO
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult female patients with MBC | This is an observational study, no interventions are specified |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tumor Progression (TTP)
Measured: 6 months after last-patient-in (LPI)
Secondary outcomes (12)
Overall Response Rate (ORR)
Measured: 6 months after last-patient-in (LPI)
Overall survival (OS)
Measured: 6 months after last-patient-in (LPI)
Time to treatment discontinuation
Measured: 6 months after last-patient-in (LPI)
Number of participants with Adverse Events as a measure of safety and tolerability
Measured: Until 30 days after discontinuation of Nab-paclitaxel
Relative dosage of Nab-Paclitaxel
Measured: Until discontinuation of Nab-Paclitaxel, up to 6 month
Intensity of peripheral neuropathy
Measured: Until discontinuation of Nab-Paclitaxel, up to 6 month
Occurence of neutropenia
Measured: Until discontinuation of Nab-Paclitaxel, up to 6 month
Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics)
Measured: Until discontinuation of Nab-Paclitaxel, up to 6 month
Patient reported outcome on Quality of life and adverse events
Assessed by questionnaires FACT-G, FACT-B, FACT-Taxanes and a pain questionnaire of the Robert-Koch-Institute.
Measured: At baseline, 3 and 6 months after start of treatment
Reasons for dose modifications or discontinuation of treatment
Measured: Until discontinuation of Nab-Paclitaxel, up to 6 month
Occurence of febrile neutropenia
Measured: Until discontinuation of Nab-Paclitaxel, up to 6 month
Occurence of peripheral neuropathy
Measured: Until discontinuation of Nab-Paclitaxel, up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Salat, Prof., Principal investigator, Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689610
- Sponsor's protocol ID
- IOM-02240
- Acronym
- NABUCCO
- Status last verified
- Jun 2018
- First submitted
- 14 Aug 2012
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01689610
- Acronym / sponsor ID
- NABUCCO / IOM-02240
- Conditions
- Metastatic Breast Cancer
- Keywords
- Nab-Paclitaxel, Abraxane, Nabucco, safety, breast cancer, daily routine, peripheral neuropathy, iOMEDICO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult female patients with MBC | – | –This is an observational study, no interventions are specified |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients with metastatic breast cancer
Key inclusion criteria (1 listed)
- Female Patients with metastatic breast cancer, who are at least 18 years old (no upper age limit)
Key exclusion criteria (3 listed)
- Contraindication according to the summary of product characteristics of Abraxane®
- No signed patient informed consent form available
- pregnant or breastfeeding patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Tumor Progression (TTP)
Time frame: 6 months after last-patient-in (LPI)
12 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Salat, Prof. principal investigator
Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Tumor Progression (TTP) (time frame: 6 months after last-patient-in (LPI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.