Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients

Phase 2

Completed

• Conditions: Chemotherapy-induced Neutropenia
• Interventions: Drug: rHSA-GCSF 2.4mg; Drug: GCSF

• Registration Number: NCT03251768
• Lead Sponsor: Tianjin SinoBiotech Ltd.

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

Study Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-16
• Study Start: 2017-10-19
• Primary Completion: 2018-07-23
• Status Verified: 2018-12
• Study Completion: 2019-04-24
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	rHSA-GCSF 2.4mg	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.
Positive control group	GCSF	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)

Primary Outcome Measures

Name	Time	Method
Main curative effect evaluation index	4 weeks	The duration of the degree of Ⅳ neutropenia

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy evaluation index	8 weeks	The duration of the degree of Ⅳ neutropenia(ANC\<0.5×109/L)
Secondary efficacy evaluation index-1	8 weeks	The time required for neutrophil recovery to 2.0x109/L(
Secondary efficacy evaluation index-2	8 weeks	ANC
Secondary efficacy evaluation index-3	8 weeks	febrile neutropenia
Secondary efficacy evaluation index-4	8 weeks	The usage of antibiotics

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences Cancer Hospital; 🇨🇳 Beijing, Beijing, China