Breast CancerNCT02921191
Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated
An observational study of Breast Cancer and Lung Cancer, run by Biologics & Biosimilars Collective Intelligence Consortium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer
- What is being tested?
- filgrastim, TBO-filgrastim or pegfilgrastim
- Type of treatment
- Injection or infusion
- How many people
- 57,725 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects are selected according to inclusion criteria from a source population within the Sentinel Common Data Mode v5.0.1 (SCDM). The SCDM includes over 100 million individuals with 358 million person-years of observation time who are covered by Aetna, Anthem, Group Health Cooperative, Harvard Pilgrim Health Care, and HealthPartners. The time period assessed will be 1/1/2008-9/30/2015.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- Radiotherapy
- Chemo cycle >First: (exclude any chemotherapy cycles post the index G-CSF date)
- HIV/AIDS
- Hepatic disease
- Other non-oncology related neutropenia
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Lung Cancer
- Being tested
- filgrastim, TBO-filgrastim or pegfilgrastim
- Keywords
- recombinant human granulocyte colony-stimulating factors, G-CSFs, biosimilar, biologics, High Neutropenia Risk Chemotherapy, Biologic and Biosimilars Collective Intelligence Consortium, bbcic
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastim, TBO-filgrastim or pegfilgrastimDrug
Also called Neupogen, Neulasta, Granix, Zarxio
First cycle
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF. Receives: Drug: filgrastim, TBO-filgrastim or pegfilgrastim | |
| Breast cancer | Breast cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF (filgrastim, TBO-filgrastim or pegfilgrastim) Receives: Drug: filgrastim, TBO-filgrastim or pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalizations for severe neutropenia
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
Measured: Anticipated completion February 2017
Secondary outcomes (1)
Incidence severe neutropenia
Incidence severe neutropenia (ANC<0.5g/l)
Measured: Anticipated completion February 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startJan 2008
- Primary completionSep 2015
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57,725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biologics & Biosimilars Collective Intelligence Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Health System, Aetna, Inc., Amgen, College of Pharmacy, University of Nebraska College, College of Pharmacy, University of New England, HealthPartners Institute, Momenta Pharmaceuticals, Inc., Harvard Pilgrim Health Care
- Responsible party
- Sponsor
- Investigators
- Vanita Pindolia, PharmD, VP, Principal investigator, Henry Ford Health SystemsPam Pawloski, PharmD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921191
- Sponsor's protocol ID
- BBCIC -GCFs
- Status last verified
- Jul 2023
- First submitted
- 28 Sep 2016
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: BBCIC Charter requires transparency and publication
Publications
AMCP Task Force on Biosimilar Collective Intelligence Systems; Baldziki M, Brown J, Chan H, Cheetham TC, Conn T, Daniel GW, Hendrickson M, Hilbrich L, Johnson A, Miller SB, Moore T, Motheral B, Priddy SA, Raebel MA, Randhawa G, Surratt P, Walraven C, White TJ, Bruns K, Carden MJ, Dragovich C, Eichelberger B, Rosato E, Sega T. Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products. J Manag Care Spec Pharm. 2015 Jan;21(1):23-34. doi: 10.18553/jmcp.2015.21.1.23.
PubMed 25562770Pawloski PA, McDermott CL, Marshall JH, Pindolia V, Lockhart CM, Panozzo CA, Brown JS, Eichelberger B. BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated With High-Neutropenia Risk Chemotherapy. J Natl Compr Canc Netw. 2021 Aug 16:jnccn20268. doi: 10.6004/jnccn.2021.7027. Online ahead of print.
PubMed 34399406
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02921191
- Acronym / sponsor ID
- BBCIC -GCFs
- Conditions
- Breast Cancer, Lung Cancer
- Keywords
- recombinant human granulocyte colony-stimulating factors, G-CSFs, biosimilar, biologics, High Neutropenia Risk Chemotherapy, Biologic and Biosimilars Collective Intelligence Consortium, bbcic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57,725 participants (actual)
- Lead sponsor
- Biologics & Biosimilars Collective Intelligence ConsortiumUniversity, hospital or other
- Collaborators
- Henry Ford Health System, Aetna, Inc., Amgen, College of Pharmacy, University of Nebraska College, College of Pharmacy, University of New England, HealthPartners Institute, Momenta Pharmaceuticals, Inc., Harvard Pilgrim Health Care
- Study start
- Jan 2008
- Primary completion
- Sep 2015 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Drug: filgrastim, TBO-filgrastim or pegfilgrastimLung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF. |
| Breast cancer | – | Drug: filgrastim, TBO-filgrastim or pegfilgrastimBreast cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF (filgrastim, TBO-filgrastim or pegfilgrastim) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects are selected according to inclusion criteria from a source population within the Sentinel Common Data Mode v5.0.1 (SCDM). The SCDM includes over 100 million individuals with 358 million person-years of observation time who are covered by Aetna, Anthem, Group Health Cooperative, Harvard Pilgrim Health Care, and HealthPartners. The time period assessed will be 1/1/2008-9/30/2015.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim, TBO-filgrastim or pegfilgrastimAlso: Neupogen, Neulasta, Granix, ZarxioFirst cycle | Drug | Breast cancer, Lung cancer |
Primary outcome
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
1 secondary outcome
Incidence severe neutropenia
Time frame: Anticipated completion February 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 25562770AMCP Task Force on Biosimilar Collective Intelligence Systems; Baldziki M, Brown J, Chan H, Cheetham TC, Conn T, Daniel GW, Hendrickson M, Hilbrich L, Johnson A, Miller SB, Moore T, Motheral B, Priddy SA, Raebel MA, Randhawa G, Surratt P, Walraven C, White TJ, Bruns K, Carden MJ, Dragovich C, Eichelberger B, Rosato E, Sega T. Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products. J Manag Care Spec Pharm. 2015 Jan;21(1):23-34. doi: 10.18553/jmcp.2015.21.1.23.
- Background: PubMed 34399406Pawloski PA, McDermott CL, Marshall JH, Pindolia V, Lockhart CM, Panozzo CA, Brown JS, Eichelberger B. BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated With High-Neutropenia Risk Chemotherapy. J Natl Compr Canc Netw. 2021 Aug 16:jnccn20268. doi: 10.6004/jnccn.2021.7027. Online ahead of print.
- The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was established in 2015 to address anticipated needs for post-marketed evidence generation for novel biologics, their corresponding biosimilars and other related products.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. BBCIC Charter requires transparency and publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanita Pindolia, PharmD, VP principal investigator
Henry Ford Health Systems
Pam Pawloski, PharmD principal investigator
HealthPartners Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by Biologics & Biosimilars Collective Intelligence Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalizations for severe neutropenia (time frame: Anticipated completion February 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921191, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.