Breast CancerPhase 3NCT04174599

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

A Phase 3 study testing F-627 and GRAN® in people with Breast Cancer and Neutropenia, run by EVIVE Biotechnology at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Breast Cancer, Neutropenia
What is being tested?: F-627 and GRAN®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 242 participants
Where: 1 siteChina
Study dates: 12 Apr 2018to 19 Jun 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing to sign the informed consent form and able to comply with protocol requirements;
18-75 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.

Who cannot join

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;

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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);
Patients with diseases or symptoms unsuitable for participating in the trial. For example, the study drugs may compromise the health of the patient or the assessment of adverse events may be affected.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of F-627 and GRAN® in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia

Read the detailed description

Study Stage: Phase III

Study Population: Female patients with breast cancer will be enrolled to receive at least 4 cycles of Epirubicin + Cyclophosphamide (EC) chemotherapy, that is: epirubicin 100 mg/m^2 and cyclophosphamide 600 mg/m^2.

Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical trial

Conditions: Breast Cancer, Neutropenia
Being tested: F-627, GRAN®
Medical subject headings: Breast Neoplasms, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

F-627Drug
Also called Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein
Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy
GRAN®Drug
Also called Filgrastim
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®)

Study groups in NCT04174599
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: GRAN®

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L
Measured: 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
Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L
Measured: 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
Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L
Measured: 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
Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L
Measured: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 3 or 4 Neutropenia in Cycle 2
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).
Measured: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 3 or 4 Neutropenia in Cycle 3
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).
Measured: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 3 or 4 Neutropenia in Cycle 4
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).
Measured: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 1
Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L.
Measured: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 2
Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L.
Measured: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 3
Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L.
Measured: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 4
Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L.
Measured: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 1
Grade 4 neutropenia is 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).
Measured: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 2
Grade 4 neutropenia is 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).
Measured: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 3
Grade 4 neutropenia is 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).
Measured: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 4
Grade 4 neutropenia is 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).
Measured: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles
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).
Measured: Overall 4, 21-day chemotherapy cycles(average 12 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1
Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L
Measured: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2
Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L
Measured: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3
Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L
Measured: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4
Grade 2 or greater neutropenia is defined as ANC < 1.5 × 10^9/L
Measured: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1
Grade 2 or greater neutropenia is defined as ANC < 1.5 × 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).
Measured: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2
Grade 2 or greater neutropenia is defined as ANC < 1.5 × 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).
Measured: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3
Grade 2 or greater neutropenia is defined as ANC < 1.5 × 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).
Measured: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4
Grade 2 or greater neutropenia is defined as ANC < 1.5 × 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).
Measured: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1
The minimum value of ANC measured from day 3 to day 13 of cycle 1
Measured: From day 3 to day 13 of cycle 1 (11 days)
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
FN is defined as ANC < 1.0 × 10^9/L with fever (a single measurement of body temperature >38.3 °C or body temperature ≥ 38.0 °C for more than 1 hr).
Measured: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1
If the ANC nadir during the first 13 days of the cycle is < 2.0 × 10^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10^9/L, then the recovery time = 0 days.
Measured: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2
If the ANC nadir during the first 13 days of the cycle is < 2.0 × 10^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10^9/L, then the recovery time = 0 days.
Measured: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3
If the ANC nadir during the first 13 days of the cycle is < 2.0 × 10^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10^9/L, then the recovery time = 0 days.
Measured: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4
If the ANC nadir during the first 13 days of the cycle is < 2.0 × 10^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10^9/L, then the recovery time = 0 days.
Measured: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 201819 Jun 2019

First posted22 Nov 2019
Study start12 Apr 2018
Primary completion24 Jan 2019
Study completion19 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04174599
Sponsor's protocol ID: SP11631
Status last verified: Apr 2025
First submitted: 8 Jul 2019
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 39272058

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of F-627 and GRAN® in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia
ClinicalTrials.gov ID: NCT04174599
Acronym / sponsor ID: SP11631
Conditions: Breast Cancer, Neutropenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: EVIVE BiotechnologyIndustry (pharma, biotech, devices)
Study start: 12 Apr 2018 (actual)
Primary completion: 24 Jan 2019 (actual)
Study completion: 19 Jun 2019 (actual)
First posted: 22 Nov 2019 (actual)
Results: Posted 20 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Stage: Phase III

Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical trial

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
F-627	Experimental	Drug: F-627F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
GRAN®	Active comparator	Drug: GRAN®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

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Willing to sign the informed consent form and able to comply with protocol requirements;
18-75 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;

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
F-627Also: Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion ProteinDay 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy	Drug	F-627
GRAN®Also: FilgrastimSince 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®)	Drug	GRAN®

Primary outcome

Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
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).

30 secondary outcomes

Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 3 or 4 Neutropenia in Cycle 2
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 3 or 4 Neutropenia in Cycle 3
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 3 or 4 Neutropenia in Cycle 4
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 1
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 2
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 3
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 4 Neutropenia in Cycle 4
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 1
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 2
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 3
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration of Grade 4 Neutropenia in Cycle 4
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles
Time frame: Overall 4, 21-day chemotherapy cycles(average 12 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1
Time frame: From day 3 to day 13 of cycle 1 (11 days)
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

Results and safety

Results posted to the registry on 20 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
F-627	122	113
GRAN®	120	101

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

Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks). Mean (Standard Deviation). Unit: days

Measure	F-627 n = 120	GRAN® n = 119
Value	0.68 (1.100)	0.71 (0.967)

Population analysed: All subjects who have completed cycle 1

30 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
F-627	6 of 120 (5%)	119 of 120 (99.2%)	0 of 120
GRAN®	8 of 119 (6.7%)	119 of 119 (100%)	0 of 119

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39272058Zhang 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhimin Shao, Doctor principal investigator

Fudan University Shanghai Cancer Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing F-627 and GRAN® in people with Breast Cancer and Neutropenia, run by EVIVE Biotechnology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1 (time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04174599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.