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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-12

Study Completion Date

2018-09-12

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kiki Karvounis

Role: STUDY_DIRECTOR

GenesisPharma Medical Department

Locations

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Athens

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type RESULT

PMID: 32418045 (View on PubMed)

Other Identifiers

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NIPMS-GENESIS-ONCO-GRC-001

Identifier Type: -

Identifier Source: org_study_id