Breast Cancer FemaleNCT03433560
An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)
An observational study of Breast Cancer Female and Breast Neoplasm Female, run by Kyowa Kirin Korea Co., Ltd. at 3 sites in South Korea.
Trial summary
The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women only
- Conditions the study is for
- Breast Cancer Female, Breast Neoplasm Female
- How many people
- 1,300 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 18 Jan 2018to 30 Jun 2021
- 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 19 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Please refer to the inclusion criteria
Who may be able to join
- ≥ 19 years old, and ≤ 64 years old, and
- Female patients with breast cancer receiving chemotherapy recently covered under national health insurance (only chemotherapy regimens in the table below), and
- Patients with neutropenic events (febrile neutropenia or grade 4 neutropenia) in any previous cycle that did not use G-CSF for the prevention of neutropenia
Who cannot join
- Patients with any of the followings are excluded.
- Patients with a history of allergic reactions to E-coli derived proteins, human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim
- Uses for off-label indications such as chronic myelogenous leukemia, myelodysplastic syndrome
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Bucheon Soonchunhyang University Hospital
Bucheon-si, Kyounggi, 14584
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Pusan National University Yangsan Hospital
Yangsan, Kyoungsang, 50612
About this study
Official title: An Observational, Prospective, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®) as Secondary Prophylaxis to Decrease the Incidence of Febrile Neutropenia in Korean Female Patients With Breast Cancer.
The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects.
Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia.
Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%
- Conditions
- Breast Cancer Female, Breast Neoplasm Female
- Keywords
- febrile neutropenia, neutropenia
- Medical subject headings
- Febrile Neutropenia, Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim
Measured: From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks)
Secondary outcomes (1)
The incidence of bone pain, or percentage of patients with relative dose intensity (RDI) or all adverse events as assessed by CTCAE
Measured: During the study period (~ 1months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start18 Jan 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Prospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433560
- Sponsor's protocol ID
- KKKR-Neulasta OS-01
- Status last verified
- May 2024
- First submitted
- 8 Feb 2018
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®) as Secondary Prophylaxis to Decrease the Incidence of Febrile Neutropenia in Korean Female Patients With Breast Cancer.
- ClinicalTrials.gov ID
- NCT03433560
- Acronym / sponsor ID
- KKKR-Neulasta OS-01
- Conditions
- Breast Cancer Female, Breast Neoplasm Female
- Keywords
- febrile neutropenia, neutropenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Kyowa Kirin Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Feb 2018 (actual)
- 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.
The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects.
Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia.
Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Please refer to the inclusion criteria
Key inclusion criteria (3 listed)
- ≥ 19 years old, and ≤ 64 years old, and
- Female patients with breast cancer receiving chemotherapy recently covered under national health insurance (only chemotherapy regimens in the table below), and
- Patients with neutropenic events (febrile neutropenia or grade 4 neutropenia) in any previous cycle that did not use G-CSF for the prevention of neutropenia
Key exclusion criteria (3 listed)
- Patients with any of the followings are excluded.
- Patients with a history of allergic reactions to E-coli derived proteins, human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim
- Uses for off-label indications such as chronic myelogenous leukemia, myelodysplastic syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim
Time frame: From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks)
1 secondary outcome
The incidence of bone pain, or percentage of patients with relative dose intensity (RDI) or all adverse events as assessed by CTCAE
Time frame: During the study period (~ 1months follow-up)
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 14 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Breast Neoplasm Female, run by Kyowa Kirin Korea Co., Ltd. at 3 sites in South Korea.
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 3 inclusion and 3 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim (time frame: From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.