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Chemotherapy Induced Neutropenia / Breast Cancer / Febrile Neutropenia · Observational Study
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned prospective observational study registered on ClinicalTrials.gov to evaluate bone pain associated with long-acting G-CSF prophylaxis in breast cancer patients undergoing chemotherapy. No results have been posted; the registry record describes only the protocol, planned enrollment, and primary outcome measures. Readers should not treat this as evidence of efficacy or safety until results are published.
Observational. Breast Cancer, Chemotherapy-Induced Neutropenia, Febrile Neutropenia, Bone Pain; age from 18 Years; to 69 Years. Intervention: Telpegfilgrastim Cohort; Other Long-acting G-CSF Cohort. Compared with: Non-Telpegfilgrastim long-acting G-CSF (physician-selected). n = 132. 7 study centers in China.
This is a planned prospective observational study registered on ClinicalTrials.gov to evaluate bone pain associated with long-acting G-CSF prophylaxis in breast cancer patients undergoing chemotherapy. No results have been posted; the registry record describes only the protocol, planned enrollment, and primary outcome measures. Readers should not treat this as evidence of efficacy or safety until results are published.
This is a registry record; no results have been posted and no efficacy or safety data are available.
The source did not state who this applies to in practice.
This is a registry record for a planned observational study with no results posted; it describes the protocol only and cannot support clinical conclusions.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07806084). This is a study registration, not published results. Lead sponsor: The First Affiliated Hospital with Nanjing Medical University. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 132 participants (ESTIMATED). Conditions: Breast Cancer, Chemotherapy-Induced Neutropenia, Febrile Neutropenia, Bone Pain. Primary outcome measures: Incidence of bone pain during Cycle 1 , During Cycle 1, up to 21 days after chemotherapy; Duration of bone pain during Cycle 1 , During Cycle 1, up to 21 days after chemotherapy. Brief summary: This prospective, multicenter, non-randomized controlled study aims to evaluate bone pain associated with prophylactic use of long-acting granulocyte colony-stimulating factors (G-CSFs) in patients with breast cancer receiving chemotherapy with a moderate-to-high risk of febrile neutropenia (FN). A total of 132 patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy will be enrolled at 7 study centers in China. According to the long-acting G-CSF selected by the treating physician in routine clinical practice, patients will be included in either the Telpegfilgrastim group or the non-Telpegfilgrastim group. Telpegfilgrastim is administered as a fixed 2 mg subcutaneous dose 24 hours after chemotherapy. Patients in the non-Telpegfilgrastim group receive another approved long-acting G-CSF according to the physician's clinical decision. The study will assess the incidence and duration of bone pain during the first chemotherapy cycle as the primary outcome. Bone pain during subsequent chemotherapy cycles, use of treatment for bone pain, and dose reduction or switching of long-acting G-CSF will also be evaluated. Absolute neutrophil count (ANC) and other laboratory parameters will be monitored during treatment to explore the relationship between neutrophil changes and bone pain.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.