Breast CancerPhase 4NCT04009941
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
A Phase 4 study testing PEG-rhG-CSF in people with Breast Cancer and Neutropenia, run by Peking University at 1 site in China.
Trial summary
This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Neutropenia
- What is being tested?
- PEG-rhG-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Jan 2020
- Phase
- Phase 4
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
- ECOG<=1
- Expected survival is greater than 6 months
- Qualified for chemotherapy，WBC>=3*109/L, ANC>=1.5*109/L, Hb>=80g/L, PLT>=80*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
- No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
- Liver function, ALT and AST should less than 2.5 times of the upper limit.
- Renal function, Cr and BUN should less than 1.5 times of the upper limit.
- Subjects voluntarily participate in this study and sign informed consent.
Who cannot join
- Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or epirubicin>360mg/m2
- Has received hematopoietic stem cell transplantation or bone marrow transplantation
- Other drugs are currently in clinical trials
- There are currently hard-to-control infections, body temperature is higher than 38 degrees.
- Received PEG-rhG-CSF treatment before enrollment
- Received chemotherapy in 4 weeks before enrollment
Show all 13Show fewer
- Patients with any visceral metastasis
- Patients with severe heart, kidney, liver or any other important organs chronic diseases
- Patients with severe uncontrolled diabetes
- Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
- Suspected or real drug users, substance abusers, alcoholics
- Pregnant or lactating women
- Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
- Conditions
- Breast Cancer, Neutropenia
- Being tested
- PEG-rhG-CSF
- Medical subject headings
- Breast Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
4.5mg per cycle, 24 hours after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF | Experimental | Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF. Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
RDI for each EC chemotherapy
Ratio of actual dose intensity to standard dose intensity
Measured: 60 days after the first chemotherapy
Chemotherapeutic dose adjustment due to neutropenia
percentage of dose decreasing due to neutropenia
Measured: 60 days after the first chemotherapy
overall completion rate of chemotherapy
calculate the overall chemo-completion rate among all patients
Measured: 60 days after the first chemotherapy
Secondary outcomes (3)
Incidence of febrile neutropenia
Measured: 60 days after the first chemotherapy
Incidence of Grade 3/4 ACN reduction
evaluate the incidence of Grade 3/4 absolute neutrophil count
Measured: 60 days after the first chemotherapy
Duration of Grade 3/4 ACN reduction
observe the duration of Grade 3/4 absolute neutrophil count
Measured: 60 days after the first chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Aug 2019
- Primary completion18 Jan 2020
- Study completion31 Jan 2020
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 Peking UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao OUYANG, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009941
- Sponsor's protocol ID
- BC-P26
- Status last verified
- Oct 2020
- First submitted
- 30 Jun 2019
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- 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 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT04009941
- Acronym / sponsor ID
- BC-P26
- Conditions
- Breast Cancer, Neutropenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 18 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 8 Jul 2019 (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.
This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
Study design
- Primary purpose
- Prevention
- 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-CSFPatients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
- ECOG<=1
- Expected survival is greater than 6 months
- Qualified for chemotherapy，WBC>=3*109/L, ANC>=1.5*109/L, Hb>=80g/L, PLT>=80*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
- No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
Key exclusion criteria (13 listed)
- Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or epirubicin>360mg/m2
- Has received hematopoietic stem cell transplantation or bone marrow transplantation
- Other drugs are currently in clinical trials
- There are currently hard-to-control infections, body temperature is higher than 38 degrees.
- Received PEG-rhG-CSF treatment before enrollment
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-CSF4.5mg per cycle, 24 hours after chemotherapy | Drug | PEG-rhG-CSF |
Primary outcome
RDI for each EC chemotherapy
Time frame: 60 days after the first chemotherapy
Ratio of actual dose intensity to standard dose intensity
Chemotherapeutic dose adjustment due to neutropenia
Time frame: 60 days after the first chemotherapy
percentage of dose decreasing due to neutropenia
overall completion rate of chemotherapy
Time frame: 60 days after the first chemotherapy
calculate the overall chemo-completion rate among all patients
3 secondary outcomes
Incidence of febrile neutropenia
Time frame: 60 days after the first chemotherapy
Incidence of Grade 3/4 ACN reduction
Time frame: 60 days after the first chemotherapy
Duration of Grade 3/4 ACN reduction
Time frame: 60 days after the first chemotherapy
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 28 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 4 study testing PEG-rhG-CSF in people with Breast Cancer and Neutropenia, run by Peking University 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 8 inclusion and 13 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 28 Oct 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
RDI for each EC chemotherapy (time frame: 60 days after the first chemotherapy). The study lists 3 primary outcomes in all. 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 28 Oct 2020.