Study to Compare the Efficacy and Safety of F-627 and GRAN®

NCT04174599 | Completed Phase 3 Results

• 1 other identifier: SP11631
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia

Conditions

Breast Cancer; Neutropenia

Outcome Measures

Primary Outcomes (1)

• Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1

  Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

  Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Secondary Outcomes (30)

• Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1

  Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

• Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2

  Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

• Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3

  Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

• Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4

  Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

• Duration of Grade 3 or 4 Neutropenia in Cycle 2

  Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

Study Arms (2)

F-627

EXPERIMENTAL

F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy

Drug: F-627

GRAN®

ACTIVE COMPARATOR

GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy

Drug: GRAN®

Interventions

F-627 DRUG

Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy

Also known as: Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein

F-627

GRAN® DRUG

Since day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy, continuous treatment for ≤ 2 weeks or until ANC recovers to 5.0 × 10\^9/L from nadir (investigators may refer to ANC test results from the Department of Laboratory Medicine of each study sites to decide when to discontinue GRAN®)

Also known as: Filgrastim

GRAN®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female postoperative patients with breast cancer who require adjuvant chemotherapy, and are planned to receive at least 4 cycles of EC chemotherapy, namely epirubicin 100 mg/m\^2 + cyclophosphamide 600 mg/m\^2
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the informed consent form and able to comply with protocol requirements;
• years old;
• Female postoperative patients with breast cancer who require adjuvant chemotherapy, and are planned to receive at least 4 cycles of EC chemotherapy, namely epirubicin 100 mg/m\^2 + cyclophosphamide 600 mg/m\^2;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• Absolute neutrophil count (ANC) ≥ 2.0 × 10\^9/L, hemoglobin (Hb) ≥ 11.0 g/dL, and platelet (PLT) ≥ 100 × 10\^9/L prior to enrollment;
• Hepatic and renal functions: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, serum creatinine ≤ 1.5 × ULN;
• Left ventricular ejection fraction \> 50%;
• Women without child-bearing potential, i.e., women who have had menopause for at least 1 year or who have undergone sterilization (bilateral tubal ligation, double oophorectomy or hysterectomy); patients with child-bearing potential should agree to take appropriate contraceptive measures, including condoms, spermicidal condoms, foams, gels, contraceptive barrier, intrauterine devices (IUD), and contraceptives (oral or injection), starting from 1 month before the start of the study until 30 days after the end of the study.

You may not qualify if:

• Radiation therapy within 4 weeks prior to enrollment;
• Patients with breast cancer who have received neoadjuvant chemotherapy before surgery;
• Prior bone marrow or stem cell transplant;
• With other malignant tumors other than breast cancer;
• Patients who have received a treatment with recombinant human granulocyte colony stimulating factor within 6 weeks prior to randomization;
• Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical diagnosis, ECG or other approaches;
• With any disease that may cause splenomegaly;
• With acute infection, chronic active Hepatitis B within 1 year (unless patients tested negative for HBsAg prior to enrollment), or Hepatitis C;
• Women in pregnancy or breastfeeding;
• Known HIV positive or AIDS;
• With active tuberculosis (TB); history of TB exposure, unless negative for tuberculin test; TB patients undergoing treatment; or suspected TB evaluated by chest x-ray;
• With sickle cell anemia;
• With alcohol or drug abuse that may affect the compliance with the study;
• With known hypersensitivity to granulocyte colony stimulating factor or excipients;
• Have received any other investigational drug within 1 month or 5 half-lives of the investigational drugs prior to enrollment (whichever is longer);

Sponsors & Collaborators

• EVIVE Biotechnology: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Zhang Q, Wang Z, Yao W, Wang S, Zhang G, Chen J, Hou Q, Li S, Li H, Ye C, Sun T, Yang H, Chen Z, Wang Z, Liu X, Geng C, Li X, Zhang J, Zheng H, Shao Z. A randomized, multicenter phase III Study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer. BMC Cancer. 2024 Sep 13;24(1):1143. doi: 10.1186/s12885-024-12892-5.

  PMID: 39272058 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Catrina Wang
• Organization: Evivebiotech

catrina.wang@evivebiotech.com

021-61760866

Study Officials

• Zhimin Shao, Doctor

  Fudan University Shanghai Cancer Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: November 22, 2019
• Study Start: April 12, 2018
• Primary Completion: January 24, 2019
• Study Completion: June 19, 2019
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Locations

CN (1)