An observational study in Breast Cancer and Chemotherapy-induced Neutropenia, sponsored by Zheng Yabing. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Zheng Yabing · Observational
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 200 is close to the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Zheng Yabing is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving chemotherapy with a high risk of febrile neutropenia who do not receive prophylactic G-CSF.
Other: No Prophylactic G-CSF
Participants receiving chemotherapy with a high risk of febrile neutropenia who receive prophylactic short-acting G-CSF.
Drug: Short-acting G-CSF
Participants receiving chemotherapy with a high risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF.
Drug: Long-acting G-CSF
Participants receiving chemotherapy with an intermediate risk of febrile neutropenia who do not receive prophylactic G-CSF.
Other: No Prophylactic G-CSF
Participants receiving chemotherapy with an intermediate risk of febrile neutropenia who receive prophylactic short-acting G-CSF.
Drug: Short-acting G-CSF
Participants receiving chemotherapy with an intermediate risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF.
Drug: Long-acting G-CSF
Participants receiving chemotherapy with a low risk of febrile neutropenia who do not receive prophylactic G-CSF.
Other: No Prophylactic G-CSF
Participants receiving chemotherapy with a low risk of febrile neutropenia who receive prophylactic short-acting G-CSF.
Drug: Short-acting G-CSF
Participants receiving chemotherapy with a low risk of febrile neutropenia who receive prophylactic Long-Acting G-CSF.
Drug: Long-acting G-CSF
No prophylactic granulocyte colony-stimulating factor is administered during the chemotherapy cycle.
Short-acting granulocyte colony-stimulating factor is administered prophylactically according to routine clinical practice.
Long-acting pegylated recombinant human granulocyte colony-stimulating factor administered prophylactically according to routine clinical practice.
Use of Mecapegfilgrastim for Primary and Secondary Prophylaxis
Proportion of participants receiving mecapegfilgrastim as primary prophylaxis or secondary prophylaxis during palliative systemic anticancer therapy.
Time frame: From enrollment through completion of follow-up, assessed up to 12 months.
Incidence of Febrile Neutropenia
Proportion of participants who develop febrile neutropenia during systemic anticancer treatment.
Time frame: From treatment initiation through 12 months.
Patient-Reported Quality of Life
Quality of life assessed using the Chinese versions of the EORTC QLQ-C30
Time frame: 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.
Time frame: 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.
Time frame: At baseline and during follow-up, assessed up to 12 months.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Zheng Yabing