Breast CancerPhase 3NCT01611051
A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
A Phase 3 study testing Drug: Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg and rhG-CSF 5ug/kg/day in people with Breast Cancer and Neutropenia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Neutropenia, Febrile Neutropenia
- What is being tested?
- Drug: Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg and rhG-CSF 5ug/kg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Jan 2013
- 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
- Investigator diagnosis of breast cancer
- Age 18 to 70 years
- ECOG performance status ≤ 1
- Chemotherapy naïve
- Body weight ≥ 45kg
- Hemoglobin ≥ 90g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
- Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN
Who cannot join
- Prior bone marrow or stem cell transplantation
- Received systemic antibiotics treatment within 72 h of chemotherapy
- Radiation therapy within 4 weeks of randomization into this study
- Pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital Affiliated to Academy Military Medical Science
Beijing, Beijing Municipality, 100071
About this study
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.
- Conditions
- Breast Cancer, Neutropenia, Febrile Neutropenia
- Being tested
- Drug: Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg, rhG-CSF 5ug/kg/day
- Keywords
- breast cancer, neutropenia, febrile neutropenia
- Medical subject headings
- Breast Neoplasms, Neutropenia, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Pegylated rhG-CSF: 100µg/kgDrug
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
Pegylated rhG-CSF: 6mgDrug
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
rhG-CSF 5ug/kg/dayDrug
Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
| Study group | Role | What they receive |
|---|---|---|
| Pegylated rhG-CSF: 100µg/kg | Experimental | Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg Receives: Drug: Drug: Pegylated rhG-CSF: 100µg/kg |
| Pegylated rhG-CSF: 6mg | Experimental | Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg Receives: Drug: Pegylated rhG-CSF: 6mg |
| rhG-CSF 5ug/kg/day | Active comparator | Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day Receives: Drug: rhG-CSF 5ug/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and the duration of grade 3/4 neutropenia in cycle 1
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.
Measured: 21 days
Secondary outcomes (2)
Rate and the duration of grade 3/4 neutropenia in cycle 2-4
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4.
Measured: Through cycle 2 to cycle 4
Rate of the febrile neutropenia in cycle 1
Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃.
Measured: Through 4 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
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.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611051
- Sponsor's protocol ID
- HHPG-19K -III-01
- Status last verified
- Jan 2013
- First submitted
- 31 May 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01611051
- Acronym / sponsor ID
- HHPG-19K -III-01
- Conditions
- Breast Cancer, Neutropenia, Febrile Neutropenia
- Keywords
- breast cancer, neutropenia, febrile neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 4 Jun 2012 (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.
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pegylated rhG-CSF: 100µg/kg | Experimental | Drug: Drug: Pegylated rhG-CSF: 100µg/kgChemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg |
| Pegylated rhG-CSF: 6mg | Experimental | Drug: Pegylated rhG-CSF: 6mgChemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg |
| rhG-CSF 5ug/kg/day | Active comparator | Drug: rhG-CSF 5ug/kg/dayChemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Investigator diagnosis of breast cancer
- Age 18 to 70 years
- ECOG performance status ≤ 1
- Chemotherapy naïve
- Body weight ≥ 45kg
Key exclusion criteria (4 listed)
- Prior bone marrow or stem cell transplantation
- Received systemic antibiotics treatment within 72 h of chemotherapy
- Radiation therapy within 4 weeks of randomization into this study
- Pregnancy, lactation
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 |
|---|---|---|
| Drug: Pegylated rhG-CSF: 100µg/kgPatients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2). | Drug | Pegylated rhG-CSF: 100µg/kg |
| Pegylated rhG-CSF: 6mgPatients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2). | Drug | Pegylated rhG-CSF: 6mg |
| rhG-CSF 5ug/kg/dayPatients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2). | Drug | rhG-CSF 5ug/kg/day |
Primary outcome
Rate and the duration of grade 3/4 neutropenia in cycle 1
Time frame: 21 days
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.
2 secondary outcomes
Rate and the duration of grade 3/4 neutropenia in cycle 2-4
Time frame: Through cycle 2 to cycle 4
Rate of the febrile neutropenia in cycle 1
Time frame: Through 4 cycles
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 8 Jan 2013.
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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.
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 Drug: Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg and rhG-CSF 5ug/kg/day in people with Breast Cancer and Neutropenia, run by Jiangsu HengRui Medicine Co., Ltd. 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 8 Jan 2013. 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?
Rate and the duration of grade 3/4 neutropenia in cycle 1 (time frame: 21 days). 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 8 Jan 2013; AzTrials last refreshed its copy on 26 Oct 2026.