Breast CancerPhase 2NCT04477616
Injection Regimen Trial of PEG-rhG-CSF During Breast Cancer Chemotherapy
A Phase 2 study testing Day 7 regimen and Day 3 regimen in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to try to find a better injection regimen (including time and dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN in breast cancer patients who receive chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Day 7 regimen and Day 3 regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2021to 6 Nov 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Received systemic or local treatment for tumors, including chemotherapy, radiotherapy, and endocrine therapy.
- A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
- The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
- Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue disease or bone marrow function suppression, and other diseases, can not tolerate chemotherapy-related treatments.
- Two-dimensional echocardiography detection LVEF <55%.
- Severe cardiovascular and cerebrovascular diseases within the first 6 months of randomization (eg unstable angina, chronic heart failure, uncontrollable hypertension> 150/90 mmHg, myocardial infarction, or cerebrovascular accident).
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- NCI peripheral neurotoxicity grade ≥2.
- Those taking glucocorticoids.
- Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab, or pertuzumab.
- Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age.
- Pregnant and lactating women.
- After joining the test, a pregnancy test (+) before using the drug.
- There are mental illness, cognitive impairment, unable to understand the test plan and side effects, unable to complete the test plan, and follow-up workers (systematic evaluation is required before the trial is enrolled).
- No personal freedom and independent civil capacity.
- The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: Injection Regimen Trial of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (PEG-rhG-CSF) in Preventing Bone Marrow Suppression and/or Febrile Neutropenia (FN) During Breast Cancer Chemotherapy
The purpose of this study is to try to find a better injection regimen (including time and dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN in breast cancer patients who receive chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Day 7 regimen, Day 3 regimen
- Keywords
- PEG-rhG-CSF, Bone marrow suppression, Febrile neutropenia, Breast cancer, Chemotherapy
- Medical subject headings
- Breast Neoplasms, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day 7 regimenDrug
patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
Day 3 regimenDrug
patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental/PEG-rhG-CSF | Experimental | patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. Receives: Drug: Day 7 regimen |
| Comparator: Comparator/PEG-rhG-CSF | Active comparator | patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. Receives: Drug: Day 3 regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rates of grade III/IV neutropenia during the first and second chemotherapy cycle
grade III or IV neutropenia (ANC < 1x 10^9/L or 0.5 x 10^9/L)
Measured: up to 9 weeks
the rates of FN during the first and second chemotherapy cycle
the occurrent rate of FN（FN：Body temperature ≥38.3°C or ≥38.0°C continued for 1 h, with neutrophil count <500/mcl or neutrophil count <1000/mcl, but expected to drop to <500/ mcl after 48 hours .）
Measured: up to 9 weeks
Secondary outcomes (2)
Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg
If WBC >= 10 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle
Measured: up to 9 weeks
Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle
Adverse reactions
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start13 Jul 2021
- Primary completion6 Oct 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jue Wang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiaoming Zha, MD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477616
- Sponsor's protocol ID
- NBC Che001
- Status last verified
- Feb 2023
- First submitted
- 16 Jul 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu Y, Huang L, Wang J, He J, Wang Y, Zhang W, Chen R, Huang X, Liu J, Wan X, Shi W, Xu L, Zha X. Exploring optimal administration timing of pegylated recombinant human granulocyte colony-stimulating factor for chemotherapy-induced neutropenia in early breast cancer treated with pharmorubicin and endoxan: a prospective randomized controlled clinical trial. BMC Cancer. 2024 Nov 12;24(1):1387. doi: 10.1186/s12885-024-13156-y.
PubMed 39533204
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Regimen Trial of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (PEG-rhG-CSF) in Preventing Bone Marrow Suppression and/or Febrile Neutropenia (FN) During Breast Cancer Chemotherapy
- ClinicalTrials.gov ID
- NCT04477616
- Acronym / sponsor ID
- NBC Che001
- Conditions
- Breast Cancer
- Keywords
- PEG-rhG-CSF, Bone marrow suppression, Febrile neutropenia, Breast cancer, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 20 Jul 2020 (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.
The purpose of this study is to try to find a better injection regimen (including time and dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN in breast cancer patients who receive chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental/PEG-rhG-CSF | Experimental | Drug: Day 7 regimenpatients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. |
| Comparator: Comparator/PEG-rhG-CSF | Active comparator | Drug: Day 3 regimenpatients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Received systemic or local treatment for tumors, including chemotherapy, radiotherapy, and endocrine therapy.
- A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
- The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
- Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue disease or bone marrow function suppression, and other diseases, can not tolerate chemotherapy-related treatments.
- Two-dimensional echocardiography detection LVEF <55%.
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 |
|---|---|---|
| Day 7 regimenpatients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. | Drug | Experimental: Experimental/PEG-rhG-CSF |
| Day 3 regimenpatients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. | Drug | Comparator: Comparator/PEG-rhG-CSF |
Primary outcome
the rates of grade III/IV neutropenia during the first and second chemotherapy cycle
Time frame: up to 9 weeks
grade III or IV neutropenia (ANC < 1x 10^9/L or 0.5 x 10^9/L)
the rates of FN during the first and second chemotherapy cycle
Time frame: up to 9 weeks
the occurrent rate of FN（FN：Body temperature ≥38.3°C or ≥38.0°C continued for 1 h, with neutrophil count <500/mcl or neutrophil count <1000/mcl, but expected to drop to <500/ mcl after 48 hours .）
2 secondary outcomes
Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg
Time frame: up to 9 weeks
Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle
Time frame: up to 9 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 23 Feb 2023.
- Derived from this study: PubMed 39533204Xu Y, Huang L, Wang J, He J, Wang Y, Zhang W, Chen R, Huang X, Liu J, Wan X, Shi W, Xu L, Zha X. Exploring optimal administration timing of pegylated recombinant human granulocyte colony-stimulating factor for chemotherapy-induced neutropenia in early breast cancer treated with pharmorubicin and endoxan: a prospective randomized controlled clinical trial. BMC Cancer. 2024 Nov 12;24(1):1387. doi: 10.1186/s12885-024-13156-y.
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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.
Xiaoming Zha, MD study director
The First Affiliated Hospital with Nanjing Medical University
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 Day 7 regimen and Day 3 regimen in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 0 inclusion and 15 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 23 Feb 2023. 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?
the rates of grade III/IV neutropenia during the first and second chemotherapy cycle (time frame: up to 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04477616, which also lists 1 linked publication.
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 23 Feb 2023.