NCT02119715

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 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

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2 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

February 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
Last Updated

April 22, 2014

Status Verified

April 1, 2014

Enrollment Period

1.5 years

First QC Date

April 17, 2014

Last Update Submit

April 17, 2014

Conditions

Breast CancerNeutropeniaFebrile Neutropenia

Keywords

Breast CancerNeutropeniaFebrile Neutropenia

Outcome Measures

Primary Outcomes (1)

  • Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L

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

    6 weeks

Secondary Outcomes (2)

  • Incidence of the febrile neutropenia in cycle 1 and cycle 2

    6 weeks

  • ANC alteration in cycle 1 and cycle 2

    6 weeks

Study Arms (3)

Pegylated rhG-CSF 100μg/kg

EXPERIMENTAL

Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4

Drug: Pegylated rhG-CSF 100μg/kg

Pegylated rhG-CSF 150μg/kg

EXPERIMENTAL

Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K)150 μg/kg in cycle 2 to 4

Drug: Pegylated rhG-CSF:150 μg/kg

G-CSF 5 μg/kg/d

ACTIVE COMPARATOR

Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4

Drug: rhG-CSF 5 μg/kg/day

Interventions

Pegylated rhG-CSF 100μg/kgDRUG

Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).

Also known as: HHPG-19K 100µg/kg
Pegylated rhG-CSF 100μg/kg
Pegylated rhG-CSF:150 μg/kgDRUG

Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).

Also known as: HHPG-19K 150μg/kg
Pegylated rhG-CSF 150μg/kg
rhG-CSF 5 μg/kg/dayDRUG

Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L（3）ANC counts exceed 15×109/L at anytime.

Also known as: Jie Xin 5 μg/kg/day
G-CSF 5 μg/kg/d

Eligibility Criteria

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

You may qualify if:

  • Pathology diagnosis of breast cancer,Chemotherapy naïve
  • ECOG performance status 0-1
  • Age 18 to 70 years
  • Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
  • White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L
  • Alanine aminotransferase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN
  • No obvious cardiac dysfunction

You may not qualify if:

  • Prior bone marrow or stem cell transplantation
  • Received systemic antibiotics treatment within 72 h of chemotherapy
  • Other disease might have influence on bone marrow function
  • Radiation therapy within 4 weeks of randomization into this study
  • Previous exposure or or allergic to Pegylated rhG-CSF
  • Pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

307 Hospital Affiliated to Academy Military Medical Science

Beijing, China

Location

MeSH Terms

Conditions

Breast NeoplasmsNeutropeniaFebrile Neutropenia

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

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

Study Officials

  • ZeFei Jiang, M.D

    307 Hospital Affiliated to Academy Military Medical Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 22, 2014

Study Start

February 1, 2011

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations

CN(1)