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CompletedNCT02626013ABReastUpdated Nov 30, 2020

Real-world Evidence Prospective Study on the Effect of Nab-paclitaxel Treatment on the Clinical Outcomes and HRQoL in Patients With MBC in Greece

An observational study in Metastatic Breast Cancer, sponsored by Genesis Pharma S.A.. Completed at 1 site in Greece. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-30.

Sponsored by Genesis Pharma S.A. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
156
Ages
18 Years and older
Sex
Female
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Study summary

This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat population. Notably, the data generated in the context of this study will serve as complementary evidence to that of the tightly and strictly controlled pre-registration clinical trial setting, which is of essential importance especially in patient populations with diseases of complex and heterogeneous biology, such as breast cancer.

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Conditions studied

  • Metastatic Breast Cancer

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In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 156 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Genesis Pharma S.A. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with a histologically or cytologically confirmed diagnosis of MBC who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated

Inclusion criteria

Patients eligible for inclusion in this study have to meet all of the following criteria:

  • Adult patients (18 years and older);
  • Patients with a histologically or cytologically confirmed diagnosis of MBC who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated;
  • Patients for whom the decision to prescribe therapy with nab-paclitaxel according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of nab-paclitaxel is clearly separated from the physician's decision to include the patient in the current study;
  • Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
  • Patients must have signed an informed consent document;
  • Patients must be able to read, understand and complete the study specific questionnaire

Exclusion criteria

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation in this study:

  • Patients who have initiated treatment with nab-paclitaxel more than 7 days prior to their enrolment into the study;
  • Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
  • Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nab-paclitaxel.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
156 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Evaluation of the best objective response to nab-paclitaxel treatment in eligible MBC patients as measured from the start of therapy until disease progression, unacceptable toxicity, or termination of study participation

    The proportion of objective responders \[patients with either a complete response (CR) or a partial response (PR) as the best objective response\] as measured by routine assessments from the start of nab-paclitaxel therapy until disease progression, occurrence of unacceptable toxicity, or study participation termination whichever occurs sooner

    Time frame: as measured by routine assessments from the start of nab-paclitaxel therapy (at least 6 months post-treatment onset and up to 12 months) until disease progression, occurrence of unacceptable toxicity, or study participation termination

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Study locations

1 site
  • Athens
    Athens, GR11528, Greece
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References and documents

Publications

  • Koumarianou A, Makrantonakis P, Zagouri F, Papadimitriou C, Christopoulou A, Samantas E, Christodoulou C, Psyrri A, Bafaloukos D, Aravantinos G, Papakotoulas P, Baka S, Andreadis C, Alexopoulos A, Bompolaki I, Kampoli Kappa, Liori S, Karvounis K, Ardavanis A. ABREAST: a prospective, real-world study on the effect of nab-paclitaxel treatment on clinical outcomes and quality of life of patients with metastatic breast cancer. Breast Cancer Res Treat. 2020 Jul;182(1):85-96. doi: 10.1007/s10549-020-05677-4. Epub 2020 May 16. PubMed 32418045 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02626013
Lead sponsor
Genesis Pharma S.A.
Responsible party
Sponsor
First posted
Dec 10, 2015
Start date
Apr 12, 2016
Primary completion
Sep 12, 2018
Completion
Sep 12, 2018
Last update
Nov 30, 2020

Study contacts

Kiki Karvounis
study director · GenesisPharma Medical Department

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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