Breast CancerPhase 2NCT02119715
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
A Phase 2 study testing Pegylated rhG-CSF 100μg/kg, Pegylated rhG-CSF:150 μg/kg and rhG-CSF 5 μg/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?
- Pegylated rhG-CSF 100μg/kg, Pegylated rhG-CSF:150 μg/kg and rhG-CSF 5 μg/kg/day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Dec 2012
- Phase
- Phase 2
- 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
- Pathology diagnosis of breast cancer,Chemotherapy naïve
- ECOG performance status 0-1
- Age 18 to 70 years
- Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
- White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L
- Alanine aminotransferase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN
- No obvious cardiac dysfunction
Who cannot join
- Prior bone marrow or stem cell transplantation
- Received systemic antibiotics treatment within 72 h of chemotherapy
- Other disease might have influence on bone marrow function
- Radiation therapy within 4 weeks of randomization into this study
- Previous exposure or or allergic to Pegylated rhG-CSF
- Pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
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 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
- Pegylated rhG-CSF 100μg/kg, Pegylated rhG-CSF:150 μg/kg, rhG-CSF 5 μg/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.
Pegylated rhG-CSF 100μg/kgDrug
Also called HHPG-19K 100µg/kg
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).
Pegylated rhG-CSF:150 μg/kgDrug
Also called HHPG-19K 150μg/kg
Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).
rhG-CSF 5 μg/kg/dayDrug
Also called Jie Xin 5 μg/kg/day
Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L（3）ANC counts exceed 15×109/L at anytime.
| Study group | Role | What they receive |
|---|---|---|
| Pegylated rhG-CSF 100μg/kg | Experimental | Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4 Receives: Drug: Pegylated rhG-CSF 100μg/kg |
| Pegylated rhG-CSF 150μg/kg | Experimental | Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K)150 μg/kg in cycle 2 to 4 Receives: Drug: Pegylated rhG-CSF:150 μg/kg |
| G-CSF 5 μg/kg/d | Active comparator | Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4 Receives: Drug: rhG-CSF 5 μg/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L
Proportion and the duration of subjects developing ANC lower than 1.0×109/L
Measured: 6 weeks
Secondary outcomes (2)
Incidence of the febrile neutropenia in cycle 1 and cycle 2
Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃
Measured: 6 weeks
ANC alteration in cycle 1 and cycle 2
Weekly laboratory ANC value alteration
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionDec 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ZeFei Jiang, M.D, Principal investigator, 307 Hospital Affiliated to Academy Military Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119715
- Sponsor's protocol ID
- HHPG-19K-II-01
- Status last verified
- Apr 2014
- First submitted
- 17 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02119715
- Acronym / sponsor ID
- HHPG-19K-II-01
- Conditions
- Breast Cancer, Neutropenia, Febrile Neutropenia
- Keywords
- Breast Cancer, Neutropenia, Febrile Neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Apr 2014 (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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pegylated rhG-CSF 100μg/kg | Experimental | Drug: Pegylated rhG-CSF 100μg/kgChemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4 |
| Pegylated rhG-CSF 150μg/kg | Experimental | Drug: Pegylated rhG-CSF:150 μg/kgChemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K)150 μg/kg in cycle 2 to 4 |
| G-CSF 5 μg/kg/d | Active comparator | Drug: rhG-CSF 5 μg/kg/dayChemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathology diagnosis of breast cancer,Chemotherapy naïve
- ECOG performance status 0-1
- Age 18 to 70 years
- Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
- White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L
Key exclusion criteria (6 listed)
- Prior bone marrow or stem cell transplantation
- Received systemic antibiotics treatment within 72 h of chemotherapy
- Other disease might have influence on bone marrow function
- Radiation therapy within 4 weeks of randomization into this study
- Previous exposure or or allergic to Pegylated rhG-CSF
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 |
|---|---|---|
| Pegylated rhG-CSF 100μg/kgAlso: HHPG-19K 100µg/kgPatients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy). | Drug | Pegylated rhG-CSF 100μg/kg |
| Pegylated rhG-CSF:150 μg/kgAlso: HHPG-19K 150μg/kgPatients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy). | Drug | Pegylated rhG-CSF 150μg/kg |
| rhG-CSF 5 μg/kg/dayAlso: Jie Xin 5 μg/kg/dayPatients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L（3）ANC counts exceed 15×109/L at anytime. | Drug | G-CSF 5 μg/kg/d |
Primary outcome
Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L
Time frame: 6 weeks
Proportion and the duration of subjects developing ANC lower than 1.0×109/L
2 secondary outcomes
Incidence of the febrile neutropenia in cycle 1 and cycle 2
Time frame: 6 weeks
ANC alteration in cycle 1 and cycle 2
Time frame: 6 weeks
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 22 Apr 2014.
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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.
ZeFei Jiang, M.D principal investigator
307 Hospital Affiliated to Academy Military Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated rhG-CSF 100μg/kg, Pegylated rhG-CSF:150 μg/kg and rhG-CSF 5 μg/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 6 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 22 Apr 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L (time frame: 6 weeks). 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 22 Apr 2014.