Clinical trial NCT02655159: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Neoplasms
Keywords: Breast Cancer
Metastatic breast cancer
nab-paclitaxel
Abraxane
Observational
Retrospective
AMBER
Lead sponsor: Celgene Corporation
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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 criteria: 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to approximately 8 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 8 months
measure: Disease control rate (DCR)
timeFrame: Up to approximately 8 months
measure: Time to disease progression (TTP)
timeFrame: Up to approximately 8 months
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 8 months
measure: Overall survival (OS)
timeFrame: Up to approximately 8 months
measure: Adverse Events (AEs)
timeFrame: Up to approximately 8 months
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Complejo Hospitalario Jaén
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
state: Aragón
city: Toledo
country: Spain
facility: Hospital Virgen Salud
state: Castilla La Mancha
city: Burgos
country: Spain
facility: Hospital Universitario Burgos
state: Castilla y León
city: Salamanca
country: Spain
facility: Hospital Clínico Salamanca
state: Castilla y León
city: Valladolid
country: Spain
facility: Hospital Clínico Valladolid
state: Castilla y León
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
state: Cataluña
city: Reus
country: Spain
facility: Hospital Universitario San Joan Reus
state: Cataluña
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
state: Extremadura
city: Badajoz
country: Spain
facility: Capio Clideba
state: Extremadura
city: Orense
country: Spain
facility: Complejo Hospitalario Orense
state: Galicia
city: Cartagena
country: Spain
facility: Hospital Santa Lucía
state: Murcia
city: Pamplona
country: Spain
facility: Hospital Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: MD Anderson
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 octubre
city: Madrid
country: Spain
facility: Hospital Quirón
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
Study officials:
affiliation: Celgene Spain
name: Lorena Pellín, MD
role: STUDY_DIRECTOR
References: