Metastatic Breast CancerNCT02555696
Abraxane in Treatment of Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by Celgene at 13 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- nab-paclitaxel
- Type of treatment
- Injection or infusion
- How many people
- 203 participants
- Where
- 13 sitesAustria
- Study dates
- 31 May 2012to 31 Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic breast cancer
Who may be able to join
- Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC)
- Signed Informed Consent
- Participants > 18 Years of Age
Who cannot join
- Pregnant or lactating females
- Neutrophils <1.5 X 10^9/L
- Hypersensivity to nab-paclitaxel
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Austria13 sites
LKH Feldkirch
Feldkirch, 6800:
Medical University Graz
Graz, 8036:
Medical University Innsbruck
Innsbruck, 6020:
LKH Leoben
Leoben, 8700:
KH Barmherzige Schwestern Linz
Linz, 4020:
LKH Salzburg
Salzburg, 5020:
LKH St. Pölten
Sankt Pölten, 3100:
LKH Steyr
Steyr, 4400:
Medical University Vienna
Vienna, 1090:
KH SMZ Ost
Vienna, 1220:
LKH Vöcklabruck
Vöcklabruck, 4840:
Klinikum Wels
Wels, 4600:
LKH Wr. Neustadt
Wiener Neustadt, 2700:
About this study
Official title: Assessment of Abraxane in Metastatic Breast Cancer in a Real-life Setting
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.
Read the 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).
- Conditions
- Metastatic Breast Cancer
- Being tested
- nab-paclitaxel
- Keywords
- Metastatic Breast Cancer, nab-paclitaxel, Abraxane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxelDrug
Also called Abraxane, ABI-007
nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel | nab-paclitaxel 260mg/m^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity Receives: Drug: nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Includes the number of participants with adverse events
Measured: Up to 3 years
Secondary outcomes (1)
Overall Response
Number of participants who achieve a response
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start31 May 2012
- Primary completion28 Feb 2016
- Study completion31 Dec 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.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guenter Voraberger, Study chair, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555696
- Sponsor's protocol ID
- NIPMS-Celgene-AUT-002
- Status last verified
- Feb 2017
- First submitted
- 18 Sep 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Abraxane in Metastatic Breast Cancer in a Real-life Setting
- ClinicalTrials.gov ID
- NCT02555696
- Acronym / sponsor ID
- NIPMS-Celgene-AUT-002
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, nab-paclitaxel, Abraxane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 31 May 2012 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 21 Sep 2015 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel | – | Drug: nab-paclitaxelnab-paclitaxel 260mg/m^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic breast cancer
Key inclusion criteria (3 listed)
- Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC)
- Signed Informed Consent
- Participants > 18 Years of Age
Key exclusion criteria (3 listed)
- Pregnant or lactating females
- Neutrophils <1.5 X 10^9/L
- Hypersensivity to nab-paclitaxel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-paclitaxelAlso: Abraxane, ABI-007nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity | Drug | nab-paclitaxel |
Primary outcome
Adverse Events
Time frame: Up to 3 years
Includes the number of participants with adverse events
1 secondary outcome
Overall Response
Time frame: Up to 3 years
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 23 Feb 2017.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Guenter Voraberger study chair
Celgene
13 sites 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 Celgene at 13 sites in Austria.
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 3 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Austria. 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?
Adverse Events (time frame: Up to 3 years). 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 23 Feb 2017.