Breast CancerPhase 3NCT02761460
The Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia
A Phase 3 study testing PEG-rhG-CSF in people with Breast Cancer, run by wang shusen at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PEG-rhG-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2016to Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent Histologically proven breast cancer
- Patients need to accept many cycles chemotherapy alone
- appears III/IV neutropenia after last cycle of chemotherapy, and plan in the subsequent cycle using the same chemotherapy program.
- KPS≥70
- Lifetime is expected to more than 3 months
- Before enrollment,ANC≥ANC ≥1.5×109 /L,Platelet Count (PLT) ≥80×109 /L, White Blood Cell （WBC ）≥3.0×109 /L.
- Sign Informed Consent Form （ICF）.
Who cannot join
- There is any difficult to control infection, or within 72 h before chemotherapy received antibiotic treatment systematically
- Any abnormal bone marrow hyperplasia and other hematopoietic function was abnormal
- Suffer from other malignant tumor was not cured, or patients with brain metastasis
- Total Bilirubin （TBIL）,Alanine Transminase （ALT）,Aspartate aminotransferase(AST)>2.5×ULN
- Cr>1.5×ULN
- Be allergic to this product or other genetically engineered e. coli sources of biological products
Show all 9Show fewer
- Mental or neurological disorders
- Women with pregnancy or lactation; The childbearing age women refused to accept contraception
- The investigators think that the person doesn't fit into the group
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shusen Wang
Guangzhou, Guangdong, 510060
shusen wang, doctor, 13926168469, wangshs@sysucc.org.cn
About this study
Official title: The Study of Evaluating the Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia
The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia
Read the detailed description
Neutrophilic granulocytopenias is one of the most common and most serious complications in chemotherapy. Research shows that about 25% ~ 40% in patients receiving standard chemotherapy can appear neutropenia with fever. It can increase the risk of infection and Chemotherapy related death, and lead to the delay of chemotherapy, and maybe Reduce the curative effect of chemotherapy. RhG-CSF has widely used to prevent neutropenia, but its half-time is short, and need daily injections to maintain the effective blood drug concentration. Patients are with poor compliance, related adverse reaction and medical costs increase. At the same time, some patients appear neutropenia thought RhG-CSF is given. Therefore, how to reduce the frequency of RhG-CSF injections and more effectively prevent neutropenia more effectively, on the premise of ensure the safety of patients to achieve better effect of chemotherapy, has always been the focus of the clinical problem.
Pegylated recombinant human granulocyte-colony stimulating factor(PEG-rhG-CSF) is a first class national new drug developed by domestic pharmaceutical companies. According to some phase Ⅱand phase Ⅲ clinical trials, PEG-rhG-CSF has a good effect. The patients need only one injection for PEG-rhG-CSF each Cycle of chemotherapy, and the effect of rising white blood cell is more smoothly, and it can avoid pain of repeated injection of PEG-rhG-CSF
- Conditions
- Breast Cancer
- Being tested
- PEG-rhG-CSF
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
PEG-rhG-CSF 6mg is given for patients Greater than or equal to 45 kg, 3mg is given for those less than 45kg 24-48 hours after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF | Experimental | PEG-rhG-CSF 6mg is given for patients Greater than or equal to 45 kg, 3mg is given for those less than 45kg 24-48 hours after chemotherapy, Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of Ⅲ or Ⅳ class of neutropenia
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start4 May 2016
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wang shusen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wang shusen, Sun Yat-sen University
- Investigators
- Shusen Wang, Doctor, Study chair, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761460
- Sponsor's protocol ID
- 2015-FXY-083
- Status last verified
- May 2017
- First submitted
- 28 Apr 2016
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Evaluating the Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia
- ClinicalTrials.gov ID
- NCT02761460
- Acronym / sponsor ID
- 2015-FXY-083
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- wang shusenUniversity, hospital or other
- Study start
- 4 May 2016 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 May 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.
The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia
Detailed description
Neutrophilic granulocytopenias is one of the most common and most serious complications in chemotherapy. Research shows that about 25% ~ 40% in patients receiving standard chemotherapy can appear neutropenia with fever. It can increase the risk of infection and Chemotherapy related death, and lead to the delay of chemotherapy, and maybe Reduce the curative effect of chemotherapy. RhG-CSF has widely used to prevent neutropenia, but its half-time is short, and need daily injections to maintain the effective blood drug concentration. Patients are with poor compliance, related adverse reaction and medical costs increase. At the same time, some patients appear neutropenia thought RhG-CSF is given. Therefore, how to reduce the frequency of RhG-CSF injections and more effectively prevent neutropenia more effectively, on the premise of ensure the safety of patients to achieve better effect of chemotherapy, has always been the focus of the clinical problem.
Pegylated recombinant human granulocyte-colony stimulating factor(PEG-rhG-CSF) is a first class national new drug developed by domestic pharmaceutical companies. According to some phase Ⅱand phase Ⅲ clinical trials, PEG-rhG-CSF has a good effect. The patients need only one injection for PEG-rhG-CSF each Cycle of chemotherapy, and the effect of rising white blood cell is more smoothly, and it can avoid pain of repeated injection of PEG-rhG-CSF
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF | Experimental | Drug: PEG-rhG-CSFPEG-rhG-CSF 6mg is given for patients Greater than or equal to 45 kg, 3mg is given for those less than 45kg 24-48 hours after chemotherapy, |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent Histologically proven breast cancer
- Patients need to accept many cycles chemotherapy alone
- appears III/IV neutropenia after last cycle of chemotherapy, and plan in the subsequent cycle using the same chemotherapy program.
- KPS≥70
- Lifetime is expected to more than 3 months
Key exclusion criteria (9 listed)
- There is any difficult to control infection, or within 72 h before chemotherapy received antibiotic treatment systematically
- Any abnormal bone marrow hyperplasia and other hematopoietic function was abnormal
- Suffer from other malignant tumor was not cured, or patients with brain metastasis
- Total Bilirubin （TBIL）,Alanine Transminase （ALT）,Aspartate aminotransferase(AST)>2.5×ULN
- Cr>1.5×ULN
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 |
|---|---|---|
| PEG-rhG-CSFPEG-rhG-CSF 6mg is given for patients Greater than or equal to 45 kg, 3mg is given for those less than 45kg 24-48 hours after chemotherapy | Drug | PEG-rhG-CSF |
Primary outcome
the rate of Ⅲ or Ⅳ class of neutropenia
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Shusen Wang, Doctor study chair
Sun Yat-Sen University Cancer Center
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 PEG-rhG-CSF in people with Breast Cancer, run by wang shusen 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 9 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: status not confirmed, as of the sponsor's last update on 1 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Xu, Doctor (13711277870, xufei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of Ⅲ or Ⅳ class of neutropenia (time frame: 1 years). 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 1 Jun 2017.