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Spots Global Cancer Trial Database for Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

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Trial Identification

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

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

Study ID: NCT02655159

Interventions

Study Description

Brief 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. 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: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Complejo Hospitalario Jaén, Jaén, Andalucía, Spain

Hospital Clínico Lozano Blesa, Zaragoza, Aragón, Spain

Hospital Virgen Salud, Toledo, Castilla La Mancha, Spain

Hospital Universitario Burgos, Burgos, Castilla y León, Spain

Hospital Clínico Salamanca, Salamanca, Castilla y León, Spain

Hospital Clínico Valladolid, Valladolid, Castilla y León, Spain

Hospital Vall d´Hebron, Barcelona, Cataluña, Spain

Hospital Universitario San Joan Reus, Reus, Cataluña, Spain

Hospital Infanta Cristina, Badajoz, Extremadura, Spain

Capio Clideba, Badajoz, Extremadura, Spain

Complejo Hospitalario Orense, Orense, Galicia, Spain

Hospital Santa Lucía, Cartagena, Murcia, Spain

Hospital Navarra, Pamplona, Navarra, Spain

Hospital Gregorio Marañón, Madrid, , Spain

MD Anderson, Madrid, , Spain

Hospital Clínico San Carlos, Madrid, , Spain

Hospital 12 octubre, Madrid, , Spain

Hospital Quirón, Madrid, , Spain

Hospital Morales Meseguer, Murcia, , Spain

Contact Details

Name: Lorena Pellín, MD

Affiliation: Celgene Spain

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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