NCT04009941

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4 breast-cancer

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

June 30, 2019

Last Update Submit

October 26, 2020

Conditions

Breast CancerNeutropenia

Outcome Measures

Primary Outcomes (3)

  • RDI for each EC chemotherapy

    Ratio of actual dose intensity to standard dose intensity

    60 days after the first chemotherapy

  • Chemotherapeutic dose adjustment due to neutropenia

    percentage of dose decreasing due to neutropenia

    60 days after the first chemotherapy

  • overall completion rate of chemotherapy

    calculate the overall chemo-completion rate among all patients

    60 days after the first chemotherapy

Secondary Outcomes (3)

  • Incidence of febrile neutropenia

    60 days after the first chemotherapy

  • Incidence of Grade 3/4 ACN reduction

    60 days after the first chemotherapy

  • Duration of Grade 3/4 ACN reduction

    60 days after the first chemotherapy

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSFDRUG

4.5mg per cycle, 24 hours after chemotherapy

PEG-rhG-CSF

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Breast NeoplasmsNeutropenia

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of breast surgery

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 8, 2019

Study Start

August 1, 2019

Primary Completion

January 18, 2020

Study Completion

January 31, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)