Breast CancerNCT07899099
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
An observational study of Breast Cancer and Chemotherapy-induced Neutropenia, run by Zheng Yabing at 1 site in China.
Trial summary
This prospective, real-world observational registry study will evaluate the effectiveness and safety of mecapegfilgrastim for the prevention of chemotherapy-induced neutropenia in patients with advanced breast cancer receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Neutropenia
- What is being tested?
- No Prophylactic G-CSF, Short-acting G-CSF and Long-acting G-CSF
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2024to 31 Mar 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older with histologically confirmed advanced breast cancer, defined as locally recurrent disease not suitable for curative treatment or metastatic disease, will be prospectively enrolled at Zhejiang Cancer Hospital. Eligible participants have first recurrence or metastasis, or documented progression during palliative treatment, and are planned to receive a new systemic anticancer treatment regimen. Participants will be assessed for febrile neutropenia risk according to chemotherapy regimen and individual clinical risk factors and followed during treatment.
Who may be able to join
- Age 18 years or older.
- Histologically confirmed advanced breast cancer, defined as locally recurrent disease not suitable for curative treatment or metastatic disease.
- First recurrence or metastasis, or documented disease progression during palliative treatment, with a planned new systemic anticancer treatment regimen.
- Estimated life expectancy of at least 3 months.
- Ability and willingness to provide written informed consent.
Who cannot join
- Early-stage breast cancer.
- Ongoing systemic anticancer treatment without a need to change to a new treatment regimen.
- Pregnant or breastfeeding women.
- Any condition or other reason that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yabing Zheng, +86-13858065353, zhengyb@zjcc.org.cn
About this study
Official title: A Real-World Study of Mecapegfilgrastim for the Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
This prospective, real-world observational registry study will evaluate the effectiveness and safety of mecapegfilgrastim for the prevention of chemotherapy-induced neutropenia in patients with advanced breast cancer receiving chemotherapy. The decision to use mecapegfilgrastim will be made by the treating physician as part of routine clinical care. Participants will be followed to collect information on neutropenia, febrile neutropenia, treatment-related adverse events, and chemotherapy delivery.
- Conditions
- Breast Cancer, Chemotherapy-induced Neutropenia
- Being tested
- No Prophylactic G-CSF, Short-acting G-CSF, Long-acting G-CSF
- Keywords
- Mecapegfilgrastim, Advanced Breast Cancer, Febrile Neutropenia, Patient-Reported Outcomes, Prospective Observational Study
- 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.
No Prophylactic G-CSFOther
No prophylactic granulocyte colony-stimulating factor is administered during the chemotherapy cycle.
Short-acting G-CSFDrug
Short-acting granulocyte colony-stimulating factor is administered prophylactically according to routine clinical practice.
Long-acting G-CSFDrug
Long-acting pegylated recombinant human granulocyte colony-stimulating factor administered prophylactically according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| High FN Risk - No Prophylaxis | Participants receiving chemotherapy with a high risk of febrile neutropenia who do not receive prophylactic G-CSF. Receives: Other: No Prophylactic G-CSF | |
| High FN Risk - Short-Acting G-CSF | Participants receiving chemotherapy with a high risk of febrile neutropenia who receive prophylactic short-acting G-CSF. Receives: Drug: Short-acting G-CSF | |
| High FN Risk - Long-Acting G-CSF | Participants receiving chemotherapy with a high risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF. Receives: Drug: Long-acting G-CSF | |
| Intermediate FN Risk - No Prophylaxis | Participants receiving chemotherapy with an intermediate risk of febrile neutropenia who do not receive prophylactic G-CSF. Receives: Other: No Prophylactic G-CSF | |
| Intermediate FN Risk - Short-Acting G-CSF | Participants receiving chemotherapy with an intermediate risk of febrile neutropenia who receive prophylactic short-acting G-CSF. Receives: Drug: Short-acting G-CSF | |
| Intermediate FN Risk - Long-Acting G-CSF | Participants receiving chemotherapy with an intermediate risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF. Receives: Drug: Long-acting G-CSF | |
| Low FN Risk - No Prophylaxis | Participants receiving chemotherapy with a low risk of febrile neutropenia who do not receive prophylactic G-CSF. Receives: Other: No Prophylactic G-CSF | |
| Low FN Risk - Short-Acting G-CSF | Participants receiving chemotherapy with a low risk of febrile neutropenia who receive prophylactic short-acting G-CSF. Receives: Drug: Short-acting G-CSF | |
| Low FN Risk - Long-Acting G-CSF | Participants receiving chemotherapy with a low risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF. Receives: Drug: Long-acting G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Mecapegfilgrastim for Primary and Secondary Prophylaxis
Proportion of participants receiving mecapegfilgrastim as primary prophylaxis or secondary prophylaxis during palliative systemic anticancer therapy.
Measured: From enrollment through completion of follow-up, assessed up to 12 months.
Secondary outcomes (4)
Incidence of Febrile Neutropenia
Proportion of participants who develop febrile neutropenia during systemic anticancer treatment.
Measured: From treatment initiation through 12 months.
Patient-Reported Quality of Life
Quality of life assessed using the Chinese versions of the EORTC QLQ-C30
Measured: At baseline and during follow-up, assessed up to 12 months.
Adherence to Mecapegfilgrastim Prophylaxis
Proportion of participants who receive prophylaxis as planned, including reasons for refusal or discontinuation.
Measured: From treatment initiation through 12 months.
Patient-Reported Quality of Life
Quality of life assessed using the Chinese versions of the EORTC QLQ-BR45 questionnaires.
Measured: At baseline and during follow-up, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start24 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zheng Yabing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Yabing, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899099
- Sponsor's protocol ID
- IRB-2024-966(IIT)
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Mecapegfilgrastim for the Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07899099
- Acronym / sponsor ID
- IRB-2024-966(IIT)
- Conditions
- Breast Cancer, Chemotherapy-induced Neutropenia
- Keywords
- Mecapegfilgrastim, Advanced Breast Cancer, Febrile Neutropenia, Patient-Reported Outcomes, Prospective Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zheng YabingUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Oct 2026 (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 prospective, real-world observational registry study will evaluate the effectiveness and safety of mecapegfilgrastim for the prevention of chemotherapy-induced neutropenia in patients with advanced breast cancer receiving chemotherapy. The decision to use mecapegfilgrastim will be made by the treating physician as part of routine clinical care. Participants will be followed to collect information on neutropenia, febrile neutropenia, treatment-related adverse events, and chemotherapy delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| High FN Risk - No Prophylaxis | – | Other: No Prophylactic G-CSFParticipants receiving chemotherapy with a high risk of febrile neutropenia who do not receive prophylactic G-CSF. |
| High FN Risk - Short-Acting G-CSF | – | Drug: Short-acting G-CSFParticipants receiving chemotherapy with a high risk of febrile neutropenia who receive prophylactic short-acting G-CSF. |
| High FN Risk - Long-Acting G-CSF | – | Drug: Long-acting G-CSFParticipants receiving chemotherapy with a high risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF. |
| Intermediate FN Risk - No Prophylaxis | – | Other: No Prophylactic G-CSFParticipants receiving chemotherapy with an intermediate risk of febrile neutropenia who do not receive prophylactic G-CSF. |
| Intermediate FN Risk - Short-Acting G-CSF | – | Drug: Short-acting G-CSFParticipants receiving chemotherapy with an intermediate risk of febrile neutropenia who receive prophylactic short-acting G-CSF. |
| Intermediate FN Risk - Long-Acting G-CSF | – | Drug: Long-acting G-CSFParticipants receiving chemotherapy with an intermediate risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF. |
| Low FN Risk - No Prophylaxis | – | Other: No Prophylactic G-CSFParticipants receiving chemotherapy with a low risk of febrile neutropenia who do not receive prophylactic G-CSF. |
| Low FN Risk - Short-Acting G-CSF | – | Drug: Short-acting G-CSFParticipants receiving chemotherapy with a low risk of febrile neutropenia who receive prophylactic short-acting G-CSF. |
| Low FN Risk - Long-Acting G-CSF | – | Drug: Long-acting G-CSFParticipants receiving chemotherapy with a low risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older with histologically confirmed advanced breast cancer, defined as locally recurrent disease not suitable for curative treatment or metastatic disease, will be prospectively enrolled at Zhejiang Cancer Hospital. Eligible participants have first recurrence or metastasis, or documented progression during palliative treatment, and are planned to receive a new systemic anticancer treatment regimen. Participants will be assessed for febrile neutropenia risk according to chemotherapy regimen and individual clinical risk factors and followed during treatment.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Histologically confirmed advanced breast cancer, defined as locally recurrent disease not suitable for curative treatment or metastatic disease.
- First recurrence or metastasis, or documented disease progression during palliative treatment, with a planned new systemic anticancer treatment regimen.
- Estimated life expectancy of at least 3 months.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (4 listed)
- Early-stage breast cancer.
- Ongoing systemic anticancer treatment without a need to change to a new treatment regimen.
- Pregnant or breastfeeding women.
- Any condition or other reason that, in the investigator's judgment, makes the participant unsuitable for 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 |
|---|---|---|
| No Prophylactic G-CSFNo prophylactic granulocyte colony-stimulating factor is administered during the chemotherapy cycle. | Other | High FN Risk - No Prophylaxis, Intermediate FN Risk - No Prophylaxis, Low FN Risk - No Prophylaxis |
| Short-acting G-CSFShort-acting granulocyte colony-stimulating factor is administered prophylactically according to routine clinical practice. | Drug | High FN Risk - Short-Acting G-CSF, Intermediate FN Risk - Short-Acting G-CSF, Low FN Risk - Short-Acting G-CSF |
| Long-acting G-CSFLong-acting pegylated recombinant human granulocyte colony-stimulating factor administered prophylactically according to routine clinical practice. | Drug | High FN Risk - Long-Acting G-CSF, Intermediate FN Risk - Long-Acting G-CSF, Low FN Risk - Long-Acting G-CSF |
Primary outcome
Use of Mecapegfilgrastim for Primary and Secondary Prophylaxis
Time frame: From enrollment through completion of follow-up, assessed up to 12 months.
Proportion of participants receiving mecapegfilgrastim as primary prophylaxis or secondary prophylaxis during palliative systemic anticancer therapy.
4 secondary outcomes
Incidence of Febrile Neutropenia
Time frame: From treatment initiation through 12 months.
Patient-Reported Quality of Life
Time frame: At baseline and during follow-up, assessed up to 12 months.
Adherence to Mecapegfilgrastim Prophylaxis
Time frame: From treatment initiation through 12 months.
Patient-Reported Quality of Life
Time frame: At baseline and during follow-up, assessed up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapy-induced Neutropenia, run by Zheng Yabing 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 5 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Mecapegfilgrastim for Primary and Secondary Prophylaxis (time frame: From enrollment through completion of follow-up, assessed up to 12 months.). 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 27 Oct 2026.