NCT01611051

Brief Summary

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P25-P50 for phase_3 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

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

May 31, 2012

Last Update Submit

January 5, 2013

Conditions

Breast CancerNeutropeniaFebrile Neutropenia

Keywords

breast cancerneutropeniafebrile neutropenia

Outcome Measures

Primary Outcomes (1)

  • Rate and the duration of grade 3/4 neutropenia in cycle 1

    Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.

    21 days

Secondary Outcomes (2)

  • Rate and the duration of grade 3/4 neutropenia in cycle 2-4

    Through cycle 2 to cycle 4

  • Rate of the febrile neutropenia in cycle 1

    Through 4 cycles

Study Arms (3)

Pegylated rhG-CSF: 100µg/kg

EXPERIMENTAL

Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg

Drug: Drug: Pegylated rhG-CSF: 100µg/kg

Pegylated rhG-CSF: 6mg

EXPERIMENTAL

Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg

Drug: Pegylated rhG-CSF: 6mg

rhG-CSF 5ug/kg/day

ACTIVE COMPARATOR

Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day

Drug: rhG-CSF 5ug/kg/day

Interventions

Drug: Pegylated rhG-CSF: 100µg/kgDRUG

Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).

Pegylated rhG-CSF: 100µg/kg
Pegylated rhG-CSF: 6mgDRUG

Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).

Pegylated rhG-CSF: 6mg
rhG-CSF 5ug/kg/dayDRUG

Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).

rhG-CSF 5ug/kg/day

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Investigator diagnosis of breast cancer
  • Age 18 to 70 years
  • ECOG performance status ≤ 1
  • Chemotherapy naïve
  • Body weight ≥ 45kg
  • Hemoglobin ≥ 90g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
  • Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN

You may not qualify if:

  • Prior bone marrow or stem cell transplantation
  • Received systemic antibiotics treatment within 72 h of chemotherapy
  • Radiation therapy within 4 weeks of randomization into this study
  • Pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Affiliated to Academy Military Medical Science

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Breast NeoplasmsNeutropeniaFebrile Neutropenia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 4, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2013

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

CN(1)