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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Neoplasms

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.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28033
    • MD Anderson
  • Madrid, Spain, 28041
    • Hospital 12 Octubre
  • Madrid, Spain, 28007:
    • Hospital Gregorio Marañón
  • Madrid, Spain, 28223
    • Hospital Quirón
  • Murcia, Spain, 30008
    • Hospital Morales Meseguer
  • Andalucía
    • Jaén, Andalucía, Spain, 23007
      • Complejo Hospitalario Jaén
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • Hospital Clinico Lozano Blesa
  • Castilla La Mancha
    • Toledo, Castilla La Mancha, Spain, 45071
      • Hospital Virgen Salud
  • Castilla y León
    • Burgos, Castilla y León, Spain, 09006
      • Hospital Universitario Burgos
    • Salamanca, Castilla y León, Spain, 37007
      • Hospital Clinico Salamanca
    • Valladolid, Castilla y León, Spain, 47005:
      • Hospital Clínico Valladolid
  • Cataluña
    • Barcelona, Cataluña, Spain, 08035
      • Hospital Vall d´Hebron
    • Reus, Cataluña, Spain, 43204
      • Hospital Universitario San Joan Reus
  • Extremadura
    • Badajoz, Extremadura, Spain, 06006
      • Hospital Infanta Cristina
    • Badajoz, Extremadura, Spain, 06011
      • Capio Clideba
  • Galicia
    • Orense, Galicia, Spain, 32005
      • Complejo Hospitalario Orense
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • Hospital Santa Lucía
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	The number of patients who achieve a complete response (CR) or partial response (PR) during the first 3 treatment cycles with nab-paclitaxel and the corresponding 95% CI will be calculated.	Up to approximately 8 months
Disease control rate (DCR)	The percentage of patients with complete response (CR), partial response (PR), or stable disease (SD) for at least 16 weeks, and the corresponding 95% confidence intervals (CI) will be calculated.	Up to approximately 8 months
Time to disease progression (TTP)	Is defined as the time from the start of treatment with nab-paclitaxel to disease progression or death due to progression. TTP will be estimated by using the Kaplan-Meier method. The median and confidence interval for the median at 95% reliability (95% CI) will be calculated. In patients who show no disease progression or who have not died, the date of censoring may be the day on which the patient's death is documented, the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.	Up to approximately 8 months
Progression-free survival (PFS)	Is defined as the time from the start of treatment with nab-paclitaxel to disease progression or death from any cause. PFS will be estimated by using the Kaplan-Meier method. Patients who have shown no disease progression or who have not died at the time of data collection will be censored on the date on which it was last known that no disease progression occurred. The date of censoring may be the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.	Up to approximately 8 months
Overall survival (OS)	Is defined as the time from the start of treatment with nab-paclitaxel to death from any cause. OS will be estimated by using the Kaplan-Meier method. Patients who have not died at the time of data collection will be censored on the date on which they are last known to be alive. The date of censoring may be the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.	Up to approximately 8 months
Adverse Events (AEs)	Number of participants with adverse events	Up to approximately 8 months

Collaborators and Investigators

• Sponsor: Celgene Corporation
• Investigators: Study Director: Lorena Pellín, MD, Celgene Spain

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 13, 2016

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Breast Cancer; Observational; Metastatic breast cancer; nab-paclitaxel; Abraxane; Retrospective; AMBER
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CEL-CMM-2015-01