Back to resultsRecombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
Primary Purpose
Chemotherapy-induced Neutropenia
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rHSA-GCSF 2.4mg
GCSF
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Neutropenia focused on measuring Chemotherapy, Neutropenia, breast cancer
Eligibility Criteria
Inclusion Criteria:
- Age 18-65.
- Diagnosed breast cancer, suitable for TEC or TE .
- ECOG performance status 0 or 1.
- Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
- No obvious abnormal ecg examination.
- TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
- Cr, BUN≤2.5×ULN.
- Signed informed consent.
Exclusion Criteria:
- Chemotherapy within past 4 weeks.
- Uncontrolled inflammatory disease,axillary temperature≥38℃.
- Merging other malignant tumor.
- Pregnancy or nursing status.
- Participation in another clinical trial with and investigational product within 3 months prior to study entry.
- Severe diabetes mellitus, or poor blood sugar controller.
- Allergic disease or allergic constitution. History of protein allergy.
- History of drug addiction and alcoholism.
- Hematopoietic stem cell transplantation or organ transplantation.
- Antibiotics were treated within 72 hours before chemotherapy.
- Long-term use of hormones or immunosuppressive agents.
- Severe mental or neurological disease.
- Chronic disease of severe cardiac, kidney and liver.
- Other conditions that would be excluded from this study according to doctors'judgment.
Sites / Locations
- Chinese Academy of Medical Sciences Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group
Positive control group
Arm Description
intervention: rHSA-GCSF 2.4 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（2.4mg）will be injected subcutaneously at at 10 am (±90 min) on the 3th and 7th day of each chemotherapy cycle.After injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.
intervention: GCSF Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at 10 am (±90 min) from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. (The minimum of usage was continuous 7 days ,The maximum of usage was continuous 14 days)
Outcomes
Primary Outcome Measures
Main curative effect evaluation index
The duration of the degree of Ⅳ neutropenia
Secondary Outcome Measures
Secondary efficacy evaluation index
The duration of the degree of Ⅳ neutropenia(ANC<0.5×109/L)
Secondary efficacy evaluation index-1
The time required for neutrophil recovery to 2.0x109/L(
Secondary efficacy evaluation index-2
ANC
Secondary efficacy evaluation index-3
febrile neutropenia
Secondary efficacy evaluation index-4
The usage of antibiotics
Full Information
NCT ID
NCT03251768
First Posted
August 7, 2017
Last Updated
September 12, 2019
Sponsor
Tianjin SinoBiotech Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03251768
Brief Title
Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
Official Title
Efficacy and Safety Phase IIb Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
April 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin SinoBiotech Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia
Detailed Description
Brief Protocol: Treat the patients taking Taxotere+Epirubicin +Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE)treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
Targeted patients: breast cancer
Subjects were randomly divided into two groups. The test group received recombinant human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg treatment. Positive control group received recombinant human granulocyte colony stimuli Factor injection therapy
Number of patients: 80
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neutropenia
Keywords
Chemotherapy, Neutropenia, breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
intervention: rHSA-GCSF 2.4 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle.
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.
Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（2.4mg）will be injected subcutaneously at at 10 am (±90 min) on the 3th and 7th day of each chemotherapy cycle.After injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.
Arm Title
Positive control group
Arm Type
Active Comparator
Arm Description
intervention: GCSF Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle.
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.
Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at 10 am (±90 min) from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. (The minimum of usage was continuous 7 days ,The maximum of usage was continuous 14 days)
Intervention Type
Drug
Intervention Name(s)
rHSA-GCSF 2.4mg
Other Intervention Name(s)
Human Serum Albumin GCSF
Intervention Description
Human Serum Albumin GCSF 2.4mg at day 3 and day 7
Intervention Type
Drug
Intervention Name(s)
GCSF
Other Intervention Name(s)
jisaixin
Intervention Description
GCSF 5 mcg/kg/day
Primary Outcome Measure Information:
Title
Main curative effect evaluation index
Description
The duration of the degree of Ⅳ neutropenia
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Secondary efficacy evaluation index
Description
The duration of the degree of Ⅳ neutropenia(ANC<0.5×109/L)
Time Frame
8 weeks
Title
Secondary efficacy evaluation index-1
Description
The time required for neutrophil recovery to 2.0x109/L(
Time Frame
8 weeks
Title
Secondary efficacy evaluation index-2
Description
ANC
Time Frame
8 weeks
Title
Secondary efficacy evaluation index-3
Description
febrile neutropenia
Time Frame
8 weeks
Title
Secondary efficacy evaluation index-4
Description
The usage of antibiotics
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65.
Diagnosed breast cancer, suitable for TEC or TE .
ECOG performance status 0 or 1.
Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
No obvious abnormal ecg examination.
TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
Cr, BUN≤2.5×ULN.
Signed informed consent.
Exclusion Criteria:
Chemotherapy within past 4 weeks.
Uncontrolled inflammatory disease,axillary temperature≥38℃.
Merging other malignant tumor.
Pregnancy or nursing status.
Participation in another clinical trial with and investigational product within 3 months prior to study entry.
Severe diabetes mellitus, or poor blood sugar controller.
Allergic disease or allergic constitution. History of protein allergy.
History of drug addiction and alcoholism.
Hematopoietic stem cell transplantation or organ transplantation.
Antibiotics were treated within 72 hours before chemotherapy.
Long-term use of hormones or immunosuppressive agents.
Severe mental or neurological disease.
Chronic disease of severe cardiac, kidney and liver.
Other conditions that would be excluded from this study according to doctors'judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe XU, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33789616
Citation
Chen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, Li H, Chen Z, Sun S, Geng C, Lu J, Sun J, Wang J, Xu B. Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy. BMC Cancer. 2021 Mar 31;21(1):341. doi: 10.1186/s12885-021-08093-z.
Results Reference
derived
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Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
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