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Completed

NCT Number: NCT04009941

Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
  • ECOG<=1
  • Expected survival is greater than 6 months
  • Qualified for chemotherapy,WBC>=3*109/L, ANC>=1.5*109/L, Hb>=80g/L, PLT>=80*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
  • No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
  • Liver function, ALT and AST should less than 2.5 times of the upper limit.
  • Renal function, Cr and BUN should less than 1.5 times of the upper limit.
  • Subjects voluntarily participate in this study and sign informed consent.

Exclusion criteria

  • Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or epirubicin>360mg/m2
  • Has received hematopoietic stem cell transplantation or bone marrow transplantation
  • Other drugs are currently in clinical trials
  • There are currently hard-to-control infections, body temperature is higher than 38 degrees.
  • Received PEG-rhG-CSF treatment before enrollment
  • Received chemotherapy in 4 weeks before enrollment
  • Patients with any visceral metastasis
  • Patients with severe heart, kidney, liver or any other important organs chronic diseases
  • Patients with severe uncontrolled diabetes
  • Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
  • Suspected or real drug users, substance abusers, alcoholics
  • Pregnant or lactating women
  • Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed

Treatment and study plan

PEG-rhG-CSF

Drug

4.5mg per cycle, 24 hours after chemotherapy

Primary outcomes

  1. RDI for each EC chemotherapy

    Time frame: 60 days after the first chemotherapy

    Ratio of actual dose intensity to standard dose intensity

  2. Chemotherapeutic dose adjustment due to neutropenia

    Time frame: 60 days after the first chemotherapy

    percentage of dose decreasing due to neutropenia

  3. overall completion rate of chemotherapy

    Time frame: 60 days after the first chemotherapy

    calculate the overall chemo-completion rate among all patients

Secondary outcomes

  1. Incidence of febrile neutropenia

    Time frame: 60 days after the first chemotherapy

  2. Incidence of Grade 3/4 ACN reduction

    Time frame: 60 days after the first chemotherapy

    evaluate the incidence of Grade 3/4 absolute neutrophil count

  3. Duration of Grade 3/4 ACN reduction

    Time frame: 60 days after the first chemotherapy

    observe the duration of Grade 3/4 absolute neutrophil count

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2019
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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