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Breast NeoplasmsAMBERNCT02655159

Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

An observational study of Breast Neoplasms, run by Celgene Corporation at 19 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
How many people
46 participants
Where
19 sitesSpain
Study dates
Jan 2016to Aug 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 patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than third-line chemotherapy for metastatic disease between 2012 and 2014 will be enrolled consecutively. In addition, patients must meet the selection criteria established in this protocol.

Who may be able to join

  • Women ≥18 years of age.
  • Confirmed diagnosis of MBC (stage IV).
  • Breast adenocarcinoma confirmed histologically.
  • HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer.
  • Patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in HER2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment.
  • Ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given).

Who cannot join

  • Patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent.
  • Patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity.
  • Patients who have taken part in any clinical trial (interventional) during the study period.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Spain19 sites

  • Hospital Infanta Cristina

    Badajoz, Extremadura, 06006

  • Capio Clideba

    Badajoz, Extremadura, 06011

  • Hospital Vall d´Hebron

    Barcelona, Catalonia, 08035

  • Hospital Universitario Burgos

    Burgos, Castille and León, 09006

  • Hospital Santa Lucía

    Cartagena, Murcia, 30202

  • Complejo Hospitalario Jaén

    Jaén, Andalusia, 23007

  • Hospital Gregorio Marañón

    Madrid, Madrid, 28007:

  • MD Anderson

    Madrid, Madrid, 28033

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital 12 octubre

    Madrid, Madrid, 28041

  • Hospital Quirón

    Madrid, Madrid, 28223

  • Hospital Morales Meseguer

    Murcia, Murcia, 30008

  • Complejo Hospitalario Orense

    Ourense, Galicia, 32005

  • Hospital Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario San Joan Reus

    Reus, Catalonia, 43204

  • Hospital Clínico Salamanca

    Salamanca, Castille and León, 37007

  • Hospital Virgen Salud

    Toledo, Castille-La Mancha, 45071

  • Hospital Clínico Valladolid

    Valladolid, Castille and León, 47005:

  • Hospital Clínico Lozano Blesa

    Zaragoza, Aragon, 50009

Other trials in Spain

About this study

Official title: Retrospective Observational Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice.

To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.

Read the detailed description

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. Investigators will include all consecutive adult patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014). These patients must meet all the inclusion criteria and none of the exclusion criteria established in this protocol.

The primary objective is to describe the effectiveness of nab-paclitaxel in terms of response in early lines of chemotherapy for metastatic breast cancer in routine clinical practice.

This study plans to collect data retrospectively, provided they are available in the patient's medical record and according to routine clinical practice.

Keywords
Breast Cancer, Metastatic breast cancer, nab-paclitaxel, Abraxane, Observational, Retrospective, AMBER
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02655159
Study groupRoleWhat they receive
Abraxane® treatment in patients with metastatic breast cancerPatients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014) and who give their consent to data collection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    The number of patients who achieve a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria during treatment with nab-paclitaxel until disease progression, the end of treatment or the start of the study, whichever comes first.

    Measured: Up to approximately 8 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    The number of patients who achieve a complete response (CR) or partial response (PR) during the first 3 treatment cycles with nab-paclitaxel and the corresponding 95% CI will be calculated.

    Measured: Up to approximately 8 months

  2. Disease control rate (DCR)

    The percentage of patients with complete response (CR), partial response (PR), or stable disease (SD) for at least 16 weeks, and the corresponding 95% confidence intervals (CI) will be calculated.

    Measured: Up to approximately 8 months

  3. Time to disease progression (TTP)

    Is defined as the time from the start of treatment with nab-paclitaxel to disease progression or death due to progression. TTP will be estimated by using the Kaplan-Meier method. The median and confidence interval for the median at 95% reliability (95% CI) will be calculated. In patients who show no disease progression or who have not died, the date of censoring may be the day on which the patient's death is documented, the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.

    Measured: Up to approximately 8 months

  4. Progression-free survival (PFS)

    Is defined as the time from the start of treatment with nab-paclitaxel to disease progression or death from any cause. PFS will be estimated by using the Kaplan-Meier method. Patients who have shown no disease progression or who have not died at the time of data collection will be censored on the date on which it was last known that no disease progression occurred. The date of censoring may be the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.

    Measured: Up to approximately 8 months

  5. Overall survival (OS)

    Is defined as the time from the start of treatment with nab-paclitaxel to death from any cause. OS will be estimated by using the Kaplan-Meier method. Patients who have not died at the time of data collection will be censored on the date on which they are last known to be alive. The date of censoring may be the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.

    Measured: Up to approximately 8 months

  6. Adverse Events (AEs)

    Number of participants with adverse events

    Measured: Up to approximately 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Why it stopped: Given the infeasibility to achieve the study population together with the loss of originality in the scientific rationale, it was considered to cancel the study

Resources

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
Case-control
Time perspective
Retrospective
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655159
Sponsor's protocol ID
CEL-CMM-2015-01
Acronym
AMBER
Status last verified
Oct 2016
First submitted
12 Jan 2016
Last updated
1 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Celgene Corporation at 19 sites in Spain.

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 6 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: stopped early, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. 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 was stopped early (reason given: Given the infeasibility to achieve the study population together with the loss of originality in the scientific rationale, it was considered to cancel the study). Results are not available in the source record.

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?

Overall response rate (ORR) (time frame: Up to approximately 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655159.

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 1 Nov 2016.

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