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

NCT02655159 | Terminated

• 1 other identifier: CEL-CMM-2015-01
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 19

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.

Conditions

Breast Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  The number of patients who achieve a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria during treatment with nab-paclitaxel until disease progression, the end of treatment or the start of the study, whichever comes first.

  Up to approximately 8 months

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  Up to approximately 8 months

• Disease control rate (DCR)

  Up to approximately 8 months

• Time to disease progression (TTP)

  Up to approximately 8 months

• Progression-free survival (PFS)

  Up to approximately 8 months

• Overall survival (OS)

  Up to approximately 8 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (19)

Complejo Hospitalario Jaén

Jaén, Andalusia, 23007, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario Burgos

Burgos, Castille and León, 09006, Spain

Location

Hospital Clínico Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Hospital Clínico Valladolid

Valladolid, Castille and León, 47005:, Spain

Location

Hospital Virgen Salud

Toledo, Castille-La Mancha, 45071, Spain

Location

Hospital Vall d´Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Universitario San Joan Reus

Reus, Catalonia, 43204, Spain

Location

Hospital Infanta Cristina

Badajoz, Extremadura, 06006, Spain

Location

Capio Clideba

Badajoz, Extremadura, 06011, Spain

Location

Complejo Hospitalario Orense

Ourense, Galicia, 32005, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, 28007:, Spain

Location

MD Anderson

Madrid, Madrid, 28033, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital 12 octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Quirón

Madrid, Madrid, 28223, Spain

Location

Hospital Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

Hospital Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Hospital Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lorena Pellín, MD

  Celgene Spain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 13, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

ES (19)