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Completed

NCT Number: NCT02921191

Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated

Purpose:

With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents expiring and the FDA approval of new biosimilar and innovator biologics, patients being treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional therapeutic options. This observational study will describe the patient characteristics of new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of hospitalizations for febrile neutropenia. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator G-CSFs.

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Key information

About this study

Additional information:

To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with baseline period of 183 days with continuous medical and pharmacy coverage preceding the first prescription fill for G-CSF
  • Breast or lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF.

Exclusion criteria

During baseline 365 days, any patient with a claim for (or with)

  • Chemotherapy drug.
  • Skilled nursing facility (SNF) or hospice care
  • Diagnosis for a secondary breast cancer diagnosis
  • A second cancer diagnosis (i.e., not breast, lung, lymphoma)
  • Bone marrow or stem cell transplant
  • Radiotherapy
  • Chemo cycle >First: (exclude any chemotherapy cycles post the index G-CSF date)
  • HIV/AIDS
  • Hepatic disease
  • Other non-oncology related neutropenia

Treatment and study plan

filgrastim, TBO-filgrastim or pegfilgrastim

Drug

First cycle

Other names: Neupogen, Neulasta, Granix, Zarxio

Primary outcomes

  1. Hospitalizations for severe neutropenia

    Time frame: Anticipated completion February 2017

    Primary: Incidence of hospitalizations for febrile neutropenia in patients with breast or lung cancer receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF

Secondary outcomes

  1. Incidence severe neutropenia

    Time frame: Anticipated completion February 2017

    Incidence severe neutropenia (ANC<0.5g/l)

Sponsors and collaborators

Lead sponsor

Biologics & Biosimilars Collective Intelligence Consortium

Other

Collaborators

  • Aetna, Inc.
  • Amgen
  • College of Pharmacy, University of Nebraska College
  • College of Pharmacy, University of New England
  • Harvard Pilgrim Health Care
  • HealthPartners Institute
  • Henry Ford Health System
  • Momenta Pharmaceuticals, Inc.

Registry information

Official study title

Descriptive Analysis of First-Cycle Prophylactic Use of G-CSF in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated With High Neutropenia Risk Chemotherapy

Important dates

Study start
2008
Primary completion
2015
Study completion
2019
First posted
Oct 3, 2016
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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