Breast CancerBone PainNCT07806084
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
An observational study of Breast Cancer and Chemotherapy-Induced Neutropenia, run by The First Affiliated Hospital with Nanjing Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Breast Cancer, Chemotherapy-Induced Neutropenia, Febrile Neutropenia
- Type of treatment
- Injection or infusion
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 26 Mar 2027
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy with anthracycline- and/or taxane-containing regimens associated with a moderate-to-high risk of febrile neutropenia will be enrolled from 7 participating centers in China. Eligible patients receive prophylactic long-acting G-CSF according to the treating physician's clinical decision and are classified into the Telpegfilgrastim cohort or the other long-acting G-CSF cohort. Patients are followed for at least 3 chemotherapy cycles to evaluate bone pain, neutrophil counts, treatment for bone pain, and changes in long-acting G-CSF use.
Who may be able to join
- Histologically or cytologically confirmed breast cancer.
- Patients considered by the investigator to be suitable for neoadjuvant or adjuvant chemotherapy with an anthracycline- and/or taxane-containing regimen administered in 21-day cycles, and expected to receive at least 3 chemotherapy cycles.
- Age ≥18 years and <70 years.
- Body weight ≥45 kg.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate baseline white blood cell and neutrophil counts before chemotherapy: white blood cell count (WBC) ≥3.5 × 10^9/L and absolute neutrophil count (ANC) ≥1.5 × 10^9/L.
- Expected survival ≥3 months.
- Willing to participate in the study, able to understand the study procedures, and able to provide written informed consent.
Who cannot join
- Previous or anticipated large-field radiotherapy involving >25% of the total bone marrow.
- Significant dysfunction of major organs, including heart, lung, liver, or kidney; liver function abnormalities defined as ALT or total bilirubin >2.5 × ULN, or >5 × ULN in patients with liver metastases; hepatitis B virus infection, hepatitis C virus infection, or cirrhosis; or serum creatinine >1.5 × ULN.
- Pregnant or breastfeeding women.
- Previous or ongoing bone marrow transplantation or organ transplantation.
- Known hypersensitivity to G-CSF or any component of a G-CSF product.
- Patients who are unable to reliably understand or report their medical condition.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Non-Randomized Controlled Study on the Correlation Between Absolute Neutrophil Count (ANC) and Bone Pain During the Prevention of Chemotherapy-Induced Neutropenia and Febrile Neutropenia (CIN/FN) With Long-Acting G-CSF in Breast Cancer Patients Receiving Intermediate- to High-Risk Chemotherapy
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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Telpegfilgrastim Cohort | Patients with breast cancer who receive telpegfilgrastim for prophylaxis of chemotherapy-induced neutropenia according to the treating physician's clinical decision. Telpegfilgrastim is administered at a fixed dose of 2 mg by subcutaneous injection 24 hours after chemotherapy, once per chemotherapy cycle. | |
| Other Long-acting G-CSF Cohort | Patients with breast cancer who receive a long-acting G-CSF other than telpegfilgrastim for prophylaxis of chemotherapy-induced neutropenia according to the treating physician's clinical decision. The long-acting G-CSF may include PEG-rhG-CSF, mecapegfilgrastim, or efbemalenograstim alfa, administered according to the approved dose and routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bone pain during Cycle 1
The number and proportion of participants who experience bone pain during the first chemotherapy cycle will be assessed in the Telpegfilgrastim cohort and the other long-acting G-CSF cohort. Bone pain will be evaluated using the Numeric Rating Scale (NRS), ranging from 0 to 10.
Measured: During Cycle 1, up to 21 days after chemotherapy
Duration of bone pain during Cycle 1
The duration of bone pain will be defined as the number of consecutive days with bone pain after administration of the long-acting G-CSF during the first chemotherapy cycle.
Measured: During Cycle 1, up to 21 days after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion26 Feb 2027 (estimated)
- Study completion26 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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806084
- Sponsor's protocol ID
- NJMU-BC13
- Acronym
- Bone Pain
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data sharing is not planned. Study data will be managed in accordance with the approved study protocol, institutional requirements, and applicable participant privacy and data confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-Randomized Controlled Study on the Correlation Between Absolute Neutrophil Count (ANC) and Bone Pain During the Prevention of Chemotherapy-Induced Neutropenia and Febrile Neutropenia (CIN/FN) With Long-Acting G-CSF in Breast Cancer Patients Receiving Intermediate- to High-Risk Chemotherapy
- ClinicalTrials.gov ID
- NCT07806084
- Acronym / sponsor ID
- Bone Pain / NJMU-BC13
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Mar 2027 (estimated)
- First posted
- 8 Sep 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, 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telpegfilgrastim Cohort | – | –Patients with breast cancer who receive telpegfilgrastim for prophylaxis of chemotherapy-induced neutropenia according to the treating physician's clinical decision. Telpegfilgrastim is administered at a fixed dose of 2 mg by subcutaneous injection 24 hours after chemotherapy, once per chemotherapy cycle. |
| Other Long-acting G-CSF Cohort | – | –Patients with breast cancer who receive a long-acting G-CSF other than telpegfilgrastim for prophylaxis of chemotherapy-induced neutropenia according to the treating physician's clinical decision. The long-acting G-CSF may include PEG-rhG-CSF, mecapegfilgrastim, or efbemalenograstim alfa, administered according to the approved dose and routine clinical practice. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy with anthracycline- and/or taxane-containing regimens associated with a moderate-to-high risk of febrile neutropenia will be enrolled from 7 participating centers in China. Eligible patients receive prophylactic long-acting G-CSF according to the treating physician's clinical decision and are classified into the Telpegfilgrastim cohort or the other long-acting G-CSF cohort. Patients are followed for at least 3 chemotherapy cycles to evaluate bone pain, neutrophil counts, treatment for bone pain, and changes in long-acting G-CSF use.
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed breast cancer.
- Patients considered by the investigator to be suitable for neoadjuvant or adjuvant chemotherapy with an anthracycline- and/or taxane-containing regimen administered in 21-day cycles, and expected to receive at least 3 chemotherapy cycles.
- Age ≥18 years and <70 years.
- Body weight ≥45 kg.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Key exclusion criteria (7 listed)
- Previous or anticipated large-field radiotherapy involving >25% of the total bone marrow.
- Significant dysfunction of major organs, including heart, lung, liver, or kidney; liver function abnormalities defined as ALT or total bilirubin >2.5 × ULN, or >5 × ULN in patients with liver metastases; hepatitis B virus infection, hepatitis C virus infection, or cirrhosis; or serum creatinine >1.5 × ULN.
- Pregnant or breastfeeding women.
- Previous or ongoing bone marrow transplantation or organ transplantation.
- Known hypersensitivity to G-CSF or any component of a G-CSF product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of bone pain during Cycle 1
Time frame: During Cycle 1, up to 21 days after chemotherapy
The number and proportion of participants who experience bone pain during the first chemotherapy cycle will be assessed in the Telpegfilgrastim cohort and the other long-acting G-CSF cohort. Bone pain will be evaluated using the Numeric Rating Scale (NRS), ranging from 0 to 10.
Duration of bone pain during Cycle 1
Time frame: During Cycle 1, up to 21 days after chemotherapy
The duration of bone pain will be defined as the number of consecutive days with bone pain after administration of the long-acting G-CSF during the first chemotherapy cycle.
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 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data sharing is not planned. Study data will be managed in accordance with the approved study protocol, institutional requirements, and applicable participant privacy and data confidentiality requirements.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapy-Induced Neutropenia, run by The First Affiliated Hospital with Nanjing Medical University.
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 7 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Wei Li (+86 13851603656, 1155073041@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bone pain during Cycle 1 (time frame: During Cycle 1, up to 21 days after chemotherapy). 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?
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 8 Sep 2026.