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

NCT03251768 | Completed Phase 2

• 1 other identifier: CHS01N-1892
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Chemotherapy-induced Neutropenia

Keywords

Chemotherapy; Neutropenia; breast cancer

Outcome Measures

Primary Outcomes (1)

• Main curative effect evaluation index

  The duration of the degree of Ⅳ neutropenia

  4 weeks

Secondary Outcomes (5)

• Secondary efficacy evaluation index

  8 weeks

• Secondary efficacy evaluation index-1

  8 weeks

• Secondary efficacy evaluation index-2

  8 weeks

• Secondary efficacy evaluation index-3

  8 weeks

• Secondary efficacy evaluation index-4

  8 weeks

Study Arms (2)

Test group

EXPERIMENTAL

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.

Drug: rHSA-GCSF 2.4mg

Positive control group

ACTIVE COMPARATOR

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)

Drug: GCSF

Interventions

rHSA-GCSF 2.4mg DRUG

Human Serum Albumin GCSF 2.4mg at day 3 and day 7

Also known as: Human Serum Albumin GCSF

Test group

GCSF DRUG

GCSF 5 mcg/kg/day

Also known as: jisaixin

Positive control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin SinoBiotech Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• 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.

  PMID: 33789616 DERIVED

MeSH Terms

Conditions

Neutropenia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Binghe XU, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  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: August 7, 2017
• First Posted: August 16, 2017
• Study Start: October 19, 2017
• Primary Completion: July 23, 2018
• Study Completion: April 24, 2019
• Last Updated: September 13, 2019

Record last verified: 2018-12

Locations

CN (1)