NeutropeniaPhase 3NCT05283616
Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer
A Phase 3 study testing Pegfilgrastim in people with Neutropenia, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently. According to the package inserts in America, Europe, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in… Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Neutropenia
- What is being tested?
- Pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2017to 15 Oct 2021
- Phase
- Phase 3
- 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 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female aged 18-69 years
- diagnosed pathologically as early breast cancer
- with indication for adjuvant chemotherapy and suitable for AC regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after AC regimen were allowed)
- received no prior chemotherapy (chemotherapy naïve)
- have Karnofsky performance status ≥ 80,
- baseline hemoglobin ≥90g/L, white blood cell count ≥4.0X10^9/L,ANC≥2.0X10^9/L, platelet count ≥100X10^9
- adequate cardiac, hepatic and renal function
Who cannot join
- enrolled onto or had not yet completed other investigational drug trials
- allergic to any component of PEG-rhG-CSF injection, or other biological products derived from genetically engineering Escherichia coli;
- pregnant or lactating women;
- previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology
Beijing, Beijing Municipality, 100021
About this study
Official title: A Randomized Controlled Study Comparing Different Doses of Pegfilgrastim as Support for Adjuvant Chemotherapy for Breast Cancer
Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently.
According to the package inserts in America, Europe, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in Japan. It is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg.
In this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving AC regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.
Read the detailed description
All patients received AC regimen (epirubicin or pirarubincin in combination with cyclophosphamide) intravenously. Epirubicin 90mg/m^2 (or pirarubicin 60mg/m^2) and cyclophosphamide 600mg/m^2 were administered on day 1 of the chemotherapy cycle. AC regimen was administered bi-weekly or 3-weekly.
Eligible patients were randomly assigned to 3mg arm (the study arm) and 6mg arm (the control arm) in a 1:1 ratio, stratified according to body weight (≤60kg or >60kg). Patients in the study arm and the control arm received a subcutaneous injection of 3mg PEG-rhG-CSF and 6mg, respectively, forty-eight hours after completing chemotherapy infusion.
- Conditions
- Neutropenia
- Being tested
- Pegfilgrastim
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegfilgrastimDrug
Pegfilgrastim 3mg per chemotherapy cycle
| Study group | Role | What they receive |
|---|---|---|
| pegfilgrastim 3mg | Experimental | Pegfilgrastim 3mg per chemotherapy cycle Receives: Drug: Pegfilgrastim |
| pegfilgrastim 6mg | Active comparator | Pegfilgrastim 6mg per chemotherapy cycle Receives: Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
timely recovery of ANC
The proportion of patients with absolute neutrophil count (ANC) ≥2.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.
Measured: 1 month
Secondary outcomes (4)
febrile neutropenia in cycle1
the incidence of neutropenia with fever in cycle 1. Blood test was used and body temperature was taken.
Measured: 1 month
grade 3/4 neutropenia in cycle 1
the incidence of absolute neutrophil count (ANC) <1.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.
Measured: 1 month
grade 4 neutropenia in cycle 1
the incidence of absolute neutrophil count (ANC) <0.5×10^9/L before the second chemotherapy cycle. Blood routine test was used.
Measured: 1 month
hospitalization due to neutropenia
the incidence of unplanned hospitalization due to neutropenia
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start15 May 2017
- Primary completion10 Oct 2019
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pin Zhang, Principal investigator, Department of Medical Oncology, Cancer Hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283616
- Sponsor's protocol ID
- CH-CS-003
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing Different Doses of Pegfilgrastim as Support for Adjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT05283616
- Acronym / sponsor ID
- CH-CS-003
- Conditions
- Neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 17 Mar 2022 (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.
Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently.
According to the package inserts in America, Europe, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in Japan. It is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg.
In this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving AC regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.
Detailed description
All patients received AC regimen (epirubicin or pirarubincin in combination with cyclophosphamide) intravenously. Epirubicin 90mg/m^2 (or pirarubicin 60mg/m^2) and cyclophosphamide 600mg/m^2 were administered on day 1 of the chemotherapy cycle. AC regimen was administered bi-weekly or 3-weekly.
Eligible patients were randomly assigned to 3mg arm (the study arm) and 6mg arm (the control arm) in a 1:1 ratio, stratified according to body weight (≤60kg or >60kg). Patients in the study arm and the control arm received a subcutaneous injection of 3mg PEG-rhG-CSF and 6mg, respectively, forty-eight hours after completing chemotherapy infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pegfilgrastim 3mg | Experimental | Drug: PegfilgrastimPegfilgrastim 3mg per chemotherapy cycle |
| pegfilgrastim 6mg | Active comparator | Drug: PegfilgrastimPegfilgrastim 6mg per chemotherapy cycle |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- female aged 18-69 years
- diagnosed pathologically as early breast cancer
- with indication for adjuvant chemotherapy and suitable for AC regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after AC regimen were allowed)
- received no prior chemotherapy (chemotherapy naïve)
- have Karnofsky performance status ≥ 80,
Key exclusion criteria (4 listed)
- enrolled onto or had not yet completed other investigational drug trials
- allergic to any component of PEG-rhG-CSF injection, or other biological products derived from genetically engineering Escherichia coli;
- pregnant or lactating women;
- previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation
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 |
|---|---|---|
| PegfilgrastimPegfilgrastim 3mg per chemotherapy cycle | Drug | pegfilgrastim 3mg, pegfilgrastim 6mg |
Primary outcome
timely recovery of ANC
Time frame: 1 month
The proportion of patients with absolute neutrophil count (ANC) ≥2.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.
4 secondary outcomes
febrile neutropenia in cycle1
Time frame: 1 month
grade 3/4 neutropenia in cycle 1
Time frame: 1 month
grade 4 neutropenia in cycle 1
Time frame: 1 month
hospitalization due to neutropenia
Time frame: 1 month
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 19 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Pin Zhang principal investigator
Department of Medical Oncology, Cancer Hospital, CAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegfilgrastim in people with Neutropenia, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 7 inclusion and 4 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
timely recovery of ANC (time frame: 1 month). 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 19 Mar 2024.