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

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

TERMINATED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Neoplasms

Keywords

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Breast Cancer Metastatic breast cancer nab-paclitaxel Abraxane Observational Retrospective AMBER

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Abraxane® treatment in patients with metastatic breast cancer

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) and who give their consent to data collection.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

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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Lorena Pellín, MD

Role: STUDY_DIRECTOR

Celgene Spain

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Spain

Other Identifiers

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CEL-CMM-2015-01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Abraxane® treatment in patients with metastatic breast cancer

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Celgene Corporation

Responsible Party

Principal Investigators

Lorena Pellín, MD

Locations

Complejo Hospitalario Jaén

Hospital Clínico Lozano Blesa

Hospital Universitario Burgos

Hospital Clínico Salamanca

Hospital Clínico Valladolid

Hospital Virgen Salud

Hospital Vall d´Hebron

Hospital Universitario San Joan Reus

Hospital Infanta Cristina

Capio Clideba

Complejo Hospitalario Orense

Hospital Gregorio Marañón

MD Anderson

Hospital Clínico San Carlos

Hospital 12 octubre

Hospital Quirón

Hospital Santa Lucía

Hospital Morales Meseguer

Hospital Navarra

Countries

Other Identifiers

CEL-CMM-2015-01