An observational study in Breast Cancer, Chemotherapy-Induced Neutropenia and Febrile Neutropenia, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
Among 57 studies in Breast Neoplasms by The First Affiliated Hospital with Nanjing Medical University — 39 open to participants now, 40 under way, none of them phase 3. Breast Neoplasms · The First Affiliated Hospital with Nanjing Medical University.
Among the 57 studies in Breast Neoplasms by The First Affiliated Hospital with Nanjing Medical University, this one is the 6th largest by planned enrollment of the 13 observational ones that give a count, is one of 10 that started in 2026, is one of 13 observational ones, reaches primary completion later than 24 of the 39 other live ones, and was the 57th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →39 of the 57 studies in Breast Neoplasms by The First Affiliated Hospital with Nanjing Medical University are open now, in 1 country. Recruiting first, the newest first:
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 65–80 · Women only · Healthy volunteers
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–75 · Women only
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–70 · Women only
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–75 · Women only
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–65 · Women only
By country, each count listing its studies:
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 69 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
57 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 132 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 76 across the 44 interventional studies, 100 across the 13 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
10 of the studies in Breast Neoplasms by The First Affiliated Hospital with Nanjing Medical University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07446452The First Affiliated Hospital with Nanjing Medical UniversityDisitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study | 2026-12-06 |
| NCT06543992The First Affiliated Hospital with Nanjing Medical UniversityEfficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis | 2026-12-13 |
| NCT07113613The First Affiliated Hospital with Nanjing Medical UniversityProspective Study on Exemption of Tumor Bed Boost Radiotherapy for pCR Patients After Breast Conserving Surgery With Neoadjuvant Therapy | 2026-12-31 |
| NCT06706726The First Affiliated Hospital with Nanjing Medical UniversityTo Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection Combined With Immediate Breast Reconstruction in Breast Cancer | 2026-12-31 |
| NCT06561646The First Affiliated Hospital with Nanjing Medical UniversityTo Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer | 2026-12-31 |
Add all 10 to your calendar (.ics) → With an account.
Among the 57 studies in Breast Neoplasms by The First Affiliated Hospital with Nanjing Medical University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 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.
Time frame: During Cycle 1, up to 21 days after chemotherapy
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2027, 4 months later.
Of 1,192 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 138. This study's planned 4 months is below that.
Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →